Probiotics for treatment of chronic constipation in children
Background Functional constipation is defined as chronic constipation with no identifiable underlying cause. It is a significant cause of morbidity in children, accounting for up to 25% of visits to paediatric gastroenterologists. Probiotic preparations may sufficiently alter the gut microbiome and...
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| Veröffentlicht in: | Cochrane database of systematic reviews 2022-03, Vol.2022 (3), p.CD014257 |
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| creator | Akobeng, Anthony K Wallace, Chris Sinopoulou, Vassiliki Gordon, Morris Akobeng, Anthony K Llanos-Chea, Alejandro Hungria, Gregory Febo-Rodriguez, Liz Fifi, Amanda Fernandez Valdes, Lilibet Langshaw, Amber Saps, Miguel |
| description | Background
Functional constipation is defined as chronic constipation with no identifiable underlying cause. It is a significant cause of morbidity in children, accounting for up to 25% of visits to paediatric gastroenterologists. Probiotic preparations may sufficiently alter the gut microbiome and promote normal gut physiology in a way that helps relieve functional constipation. Several studies have sought to address this hypothesis, as well as the role of probiotics in other functional gut disorders. Therefore, it is important to have a focused review to assess the evidence to date.
Objectives
To evaluate the efficacy and safety of probiotics for the management of chronic constipation without a physical explanation in children.
Search methods
On 28 June 2021, we searched CENTRAL, MEDLINE, Embase, CINAHL, AMED, WHO ICTR, and ClinicalTrials.gov, with no language, date, publication status, or document type limitations.
Selection criteria
We included randomised controlled trials (RCTs) that assessed probiotic preparations (including synbiotics) compared to placebo, no treatment or any other interventional preparation in people aged between 0 and 18 years old with a diagnosis of functional constipation according to consensus criteria (such as Rome IV).
Data collection and analysis
We used standard methodological procedures expected by Cochrane.
Main results
We included 14 studies (1127 randomised participants): 12 studies assessed probiotics in the treatment of functional constipation, whilst two studies investigated synbiotic preparations.
Three studies compared probiotics to placebo in relation to the frequency of defecation at study end, but we did not pool them as there was very significant unexplained heterogeneity. Four studies compared probiotics to placebo in relation to treatment success. There may be no difference in global improvement/treatment success (RR 1.29, 95% CI 0.73 to 2.26; 313 participants; low‐certainty evidence). Five studies compared probiotics to placebo in relation to withdrawals due to adverse events, with the pooled effect suggesting there may be no difference (RR 0.64, 95% CI 0.21 to 1.95; 357 participants; low‐certainty evidence).
The pooled estimate from three studies that compared probiotics plus an osmotic laxative to osmotic laxative alone found there may be no difference in frequency of defecation (MD ‐0.01, 95% CI ‐0.57 to 0.56; 268 participants; low‐certainty evidence). Two studies compared probiotics plus an osmotic laxat |
| doi_str_mv | 10.1002/14651858.CD014257.pub2 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8962960</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2644937187</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4032-e8545672933a29efe8bcd0ee11791f744dd46f2cfdf1b9323f560d61fd3374803</originalsourceid><addsrcrecordid>eNqFkF1LwzAYhYMobk7_wuilN535apqACDo_YaAXeh3aNHGRtplJp-zfm7IPpjdeJeSc95w3DwBjBCcIQnyBKMsQz_hkegsRxVk-WSxLfACGvZD2yuHefQBOQviAkDCB82MwIBmhAjE-BJcv3pXWdVaFxDifdF4XXaPbLnEmUXPvWqsS5drQ2UXRWdcmto3vtq68bk_BkSnqoM825wi83d-9Th_T2fPD0_R6lioKCU41z2jGciwIKbDQRvNSVVBrhHKBTE5pVVFmsDKVQaUgmJiMwYohUxGSUw7JCFytc-MfG12puJ4varnwtin8SrrCyt9Ka-fy3X1JLhgWrA843wR497nUoZONDUrXddFqtwwSM0oFyRHPo5Wtrcq7ELw2uxoEZY9ebtHLLfq-HMfB8f6Su7Et62i4WRu-ba1XUrmIN_b_k_un5QdjLpUG</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2644937187</pqid></control><display><type>article</type><title>Probiotics for treatment of chronic constipation in children</title><source>MEDLINE</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Cochrane Library</source><source>Alma/SFX Local Collection</source><creator>Akobeng, Anthony K ; Wallace, Chris ; Sinopoulou, Vassiliki ; Gordon, Morris ; Akobeng, Anthony K ; Llanos-Chea, Alejandro ; Hungria, Gregory ; Febo-Rodriguez, Liz ; Fifi, Amanda ; Fernandez Valdes, Lilibet ; Langshaw, Amber ; Saps, Miguel</creator><creatorcontrib>Akobeng, Anthony K ; Wallace, Chris ; Sinopoulou, Vassiliki ; Gordon, Morris ; Akobeng, Anthony K ; Llanos-Chea, Alejandro ; Hungria, Gregory ; Febo-Rodriguez, Liz ; Fifi, Amanda ; Fernandez Valdes, Lilibet ; Langshaw, Amber ; Saps, Miguel</creatorcontrib><description>Background
Functional constipation is defined as chronic constipation with no identifiable underlying cause. It is a significant cause of morbidity in children, accounting for up to 25% of visits to paediatric gastroenterologists. Probiotic preparations may sufficiently alter the gut microbiome and promote normal gut physiology in a way that helps relieve functional constipation. Several studies have sought to address this hypothesis, as well as the role of probiotics in other functional gut disorders. Therefore, it is important to have a focused review to assess the evidence to date.
Objectives
To evaluate the efficacy and safety of probiotics for the management of chronic constipation without a physical explanation in children.
Search methods
On 28 June 2021, we searched CENTRAL, MEDLINE, Embase, CINAHL, AMED, WHO ICTR, and ClinicalTrials.gov, with no language, date, publication status, or document type limitations.
Selection criteria
We included randomised controlled trials (RCTs) that assessed probiotic preparations (including synbiotics) compared to placebo, no treatment or any other interventional preparation in people aged between 0 and 18 years old with a diagnosis of functional constipation according to consensus criteria (such as Rome IV).
Data collection and analysis
We used standard methodological procedures expected by Cochrane.
Main results
We included 14 studies (1127 randomised participants): 12 studies assessed probiotics in the treatment of functional constipation, whilst two studies investigated synbiotic preparations.
Three studies compared probiotics to placebo in relation to the frequency of defecation at study end, but we did not pool them as there was very significant unexplained heterogeneity. Four studies compared probiotics to placebo in relation to treatment success. There may be no difference in global improvement/treatment success (RR 1.29, 95% CI 0.73 to 2.26; 313 participants; low‐certainty evidence). Five studies compared probiotics to placebo in relation to withdrawals due to adverse events, with the pooled effect suggesting there may be no difference (RR 0.64, 95% CI 0.21 to 1.95; 357 participants; low‐certainty evidence).
The pooled estimate from three studies that compared probiotics plus an osmotic laxative to osmotic laxative alone found there may be no difference in frequency of defecation (MD ‐0.01, 95% CI ‐0.57 to 0.56; 268 participants; low‐certainty evidence). Two studies compared probiotics plus an osmotic laxative to osmotic laxative alone in relation to global improvement/treatment success, and found there may be no difference between the treatments (RR 0.95, 95% CI 0.79 to 1.15; 139 participants; low‐certainty evidence). Three studies compared probiotics plus osmotic laxative to osmotic laxative alone in relation to withdrawals due to adverse events, but it is unclear if there is a difference between them (RR 2.86, 95% CI 0.12 to 68.35; 268 participants; very low‐certainty evidence).
Two studies compared probiotics versus magnesium oxide. It is unclear if there is a difference in frequency of defecation (MD 0.28, 95% CI ‐0.58 to 1.14; 36 participants), treatment success (RR 1.08, 95% CI 0.74 to 1.57; 36 participants) or withdrawals due to adverse events (RR 0.50, 95% CI 0.05 to 5.04; 77 participants). The certainty of the evidence is very low for these outcomes.
One study assessed the role of a synbiotic preparation in comparison to placebo. There may be higher treatment success in favour of synbiotics compared to placebo (RR 2.32, 95% CI 1.54 to 3.47; 155 participants; low‐certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group.
One study assessed a synbiotic plus paraffin compared to paraffin alone. It is uncertain if there is a difference in frequency of defecation (MD 0.74, 95% CI ‐0.96, 2.44; 66 participants; very low‐certainty evidence), or treatment success (RR 0.91, 95% CI 0.71 to 1.17; 66 participants; very low‐certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group.
One study compared a synbiotic preparation to paraffin. It is uncertain if there is a difference in frequency of defecation (MD ‐1.53, 95% CI ‐3.00, ‐0.06; 60 participants; very low‐certainty evidence) or in treatment success (RR 0.86, 95% CI 0.65, 1.13; 60 participants; very low‐certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group.
All secondary outcomes were either not reported or reported in a way that did not allow for analysis.
Authors' conclusions
There is insufficient evidence to conclude whether probiotics are efficacious in successfully treating chronic constipation without a physical explanation in children or changing the frequency of defecation, or whether there is a difference in withdrawals due to adverse events when compared with placebo. There is limited evidence from one study to suggest a synbiotic preparation may be more likely than placebo to lead to treatment success, with no difference in withdrawals due to adverse events.
There is insufficient evidence to draw efficacy or safety conclusions about the use of probiotics in combination with or in comparison to any of the other interventions reported. The majority of the studies that presented data on serious adverse events reported that no events occurred. Two studies did not report this outcome.
Future studies are needed to confirm efficacy, but the research community requires guidance on the best context for probiotics in such studies, considering where they should be best considered in a potential treatment hierarchy and should align with core outcome sets to support future interpretation of findings.</description><identifier>ISSN: 1465-1858</identifier><identifier>ISSN: 1469-493X</identifier><identifier>EISSN: 1465-1858</identifier><identifier>EISSN: 1469-493X</identifier><identifier>DOI: 10.1002/14651858.CD014257.pub2</identifier><identifier>PMID: 35349168</identifier><language>eng</language><publisher>Chichester, UK: John Wiley & Sons, Ltd</publisher><subject>Adolescent ; BOWEL ; Child ; Child, Preschool ; Chronic constipation ; Constipation ; Constipation - therapy ; Humans ; Infant ; Infant, Newborn ; Medicine General & Introductory Medical Sciences ; Probiotics ; Probiotics - adverse effects ; Treatment Outcome</subject><ispartof>Cochrane database of systematic reviews, 2022-03, Vol.2022 (3), p.CD014257</ispartof><rights>Copyright © 2022 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4032-e8545672933a29efe8bcd0ee11791f744dd46f2cfdf1b9323f560d61fd3374803</citedby><cites>FETCH-LOGICAL-c4032-e8545672933a29efe8bcd0ee11791f744dd46f2cfdf1b9323f560d61fd3374803</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,315,781,785,886,27929,27930</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35349168$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Akobeng, Anthony K</creatorcontrib><creatorcontrib>Wallace, Chris</creatorcontrib><creatorcontrib>Sinopoulou, Vassiliki</creatorcontrib><creatorcontrib>Gordon, Morris</creatorcontrib><creatorcontrib>Akobeng, Anthony K</creatorcontrib><creatorcontrib>Llanos-Chea, Alejandro</creatorcontrib><creatorcontrib>Hungria, Gregory</creatorcontrib><creatorcontrib>Febo-Rodriguez, Liz</creatorcontrib><creatorcontrib>Fifi, Amanda</creatorcontrib><creatorcontrib>Fernandez Valdes, Lilibet</creatorcontrib><creatorcontrib>Langshaw, Amber</creatorcontrib><creatorcontrib>Saps, Miguel</creatorcontrib><title>Probiotics for treatment of chronic constipation in children</title><title>Cochrane database of systematic reviews</title><addtitle>Cochrane Database Syst Rev</addtitle><description>Background
Functional constipation is defined as chronic constipation with no identifiable underlying cause. It is a significant cause of morbidity in children, accounting for up to 25% of visits to paediatric gastroenterologists. Probiotic preparations may sufficiently alter the gut microbiome and promote normal gut physiology in a way that helps relieve functional constipation. Several studies have sought to address this hypothesis, as well as the role of probiotics in other functional gut disorders. Therefore, it is important to have a focused review to assess the evidence to date.
Objectives
To evaluate the efficacy and safety of probiotics for the management of chronic constipation without a physical explanation in children.
Search methods
On 28 June 2021, we searched CENTRAL, MEDLINE, Embase, CINAHL, AMED, WHO ICTR, and ClinicalTrials.gov, with no language, date, publication status, or document type limitations.
Selection criteria
We included randomised controlled trials (RCTs) that assessed probiotic preparations (including synbiotics) compared to placebo, no treatment or any other interventional preparation in people aged between 0 and 18 years old with a diagnosis of functional constipation according to consensus criteria (such as Rome IV).
Data collection and analysis
We used standard methodological procedures expected by Cochrane.
Main results
We included 14 studies (1127 randomised participants): 12 studies assessed probiotics in the treatment of functional constipation, whilst two studies investigated synbiotic preparations.
Three studies compared probiotics to placebo in relation to the frequency of defecation at study end, but we did not pool them as there was very significant unexplained heterogeneity. Four studies compared probiotics to placebo in relation to treatment success. There may be no difference in global improvement/treatment success (RR 1.29, 95% CI 0.73 to 2.26; 313 participants; low‐certainty evidence). Five studies compared probiotics to placebo in relation to withdrawals due to adverse events, with the pooled effect suggesting there may be no difference (RR 0.64, 95% CI 0.21 to 1.95; 357 participants; low‐certainty evidence).
The pooled estimate from three studies that compared probiotics plus an osmotic laxative to osmotic laxative alone found there may be no difference in frequency of defecation (MD ‐0.01, 95% CI ‐0.57 to 0.56; 268 participants; low‐certainty evidence). Two studies compared probiotics plus an osmotic laxative to osmotic laxative alone in relation to global improvement/treatment success, and found there may be no difference between the treatments (RR 0.95, 95% CI 0.79 to 1.15; 139 participants; low‐certainty evidence). Three studies compared probiotics plus osmotic laxative to osmotic laxative alone in relation to withdrawals due to adverse events, but it is unclear if there is a difference between them (RR 2.86, 95% CI 0.12 to 68.35; 268 participants; very low‐certainty evidence).
Two studies compared probiotics versus magnesium oxide. It is unclear if there is a difference in frequency of defecation (MD 0.28, 95% CI ‐0.58 to 1.14; 36 participants), treatment success (RR 1.08, 95% CI 0.74 to 1.57; 36 participants) or withdrawals due to adverse events (RR 0.50, 95% CI 0.05 to 5.04; 77 participants). The certainty of the evidence is very low for these outcomes.
One study assessed the role of a synbiotic preparation in comparison to placebo. There may be higher treatment success in favour of synbiotics compared to placebo (RR 2.32, 95% CI 1.54 to 3.47; 155 participants; low‐certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group.
One study assessed a synbiotic plus paraffin compared to paraffin alone. It is uncertain if there is a difference in frequency of defecation (MD 0.74, 95% CI ‐0.96, 2.44; 66 participants; very low‐certainty evidence), or treatment success (RR 0.91, 95% CI 0.71 to 1.17; 66 participants; very low‐certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group.
One study compared a synbiotic preparation to paraffin. It is uncertain if there is a difference in frequency of defecation (MD ‐1.53, 95% CI ‐3.00, ‐0.06; 60 participants; very low‐certainty evidence) or in treatment success (RR 0.86, 95% CI 0.65, 1.13; 60 participants; very low‐certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group.
All secondary outcomes were either not reported or reported in a way that did not allow for analysis.
Authors' conclusions
There is insufficient evidence to conclude whether probiotics are efficacious in successfully treating chronic constipation without a physical explanation in children or changing the frequency of defecation, or whether there is a difference in withdrawals due to adverse events when compared with placebo. There is limited evidence from one study to suggest a synbiotic preparation may be more likely than placebo to lead to treatment success, with no difference in withdrawals due to adverse events.
There is insufficient evidence to draw efficacy or safety conclusions about the use of probiotics in combination with or in comparison to any of the other interventions reported. The majority of the studies that presented data on serious adverse events reported that no events occurred. Two studies did not report this outcome.
Future studies are needed to confirm efficacy, but the research community requires guidance on the best context for probiotics in such studies, considering where they should be best considered in a potential treatment hierarchy and should align with core outcome sets to support future interpretation of findings.</description><subject>Adolescent</subject><subject>BOWEL</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Chronic constipation</subject><subject>Constipation</subject><subject>Constipation - therapy</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Medicine General & Introductory Medical Sciences</subject><subject>Probiotics</subject><subject>Probiotics - adverse effects</subject><subject>Treatment Outcome</subject><issn>1465-1858</issn><issn>1469-493X</issn><issn>1465-1858</issn><issn>1469-493X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>RWY</sourceid><sourceid>EIF</sourceid><recordid>eNqFkF1LwzAYhYMobk7_wuilN535apqACDo_YaAXeh3aNHGRtplJp-zfm7IPpjdeJeSc95w3DwBjBCcIQnyBKMsQz_hkegsRxVk-WSxLfACGvZD2yuHefQBOQviAkDCB82MwIBmhAjE-BJcv3pXWdVaFxDifdF4XXaPbLnEmUXPvWqsS5drQ2UXRWdcmto3vtq68bk_BkSnqoM825wi83d-9Th_T2fPD0_R6lioKCU41z2jGciwIKbDQRvNSVVBrhHKBTE5pVVFmsDKVQaUgmJiMwYohUxGSUw7JCFytc-MfG12puJ4varnwtin8SrrCyt9Ka-fy3X1JLhgWrA843wR497nUoZONDUrXddFqtwwSM0oFyRHPo5Wtrcq7ELw2uxoEZY9ebtHLLfq-HMfB8f6Su7Et62i4WRu-ba1XUrmIN_b_k_un5QdjLpUG</recordid><startdate>20220329</startdate><enddate>20220329</enddate><creator>Akobeng, Anthony K</creator><creator>Wallace, Chris</creator><creator>Sinopoulou, Vassiliki</creator><creator>Gordon, Morris</creator><creator>Akobeng, Anthony K</creator><creator>Llanos-Chea, Alejandro</creator><creator>Hungria, Gregory</creator><creator>Febo-Rodriguez, Liz</creator><creator>Fifi, Amanda</creator><creator>Fernandez Valdes, Lilibet</creator><creator>Langshaw, Amber</creator><creator>Saps, Miguel</creator><general>John Wiley & Sons, Ltd</general><scope>7PX</scope><scope>RWY</scope><scope>ZYTZH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20220329</creationdate><title>Probiotics for treatment of chronic constipation in children</title><author>Akobeng, Anthony K ; Wallace, Chris ; Sinopoulou, Vassiliki ; Gordon, Morris ; Akobeng, Anthony K ; Llanos-Chea, Alejandro ; Hungria, Gregory ; Febo-Rodriguez, Liz ; Fifi, Amanda ; Fernandez Valdes, Lilibet ; Langshaw, Amber ; Saps, Miguel</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4032-e8545672933a29efe8bcd0ee11791f744dd46f2cfdf1b9323f560d61fd3374803</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adolescent</topic><topic>BOWEL</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>Chronic constipation</topic><topic>Constipation</topic><topic>Constipation - therapy</topic><topic>Humans</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Medicine General & Introductory Medical Sciences</topic><topic>Probiotics</topic><topic>Probiotics - adverse effects</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Akobeng, Anthony K</creatorcontrib><creatorcontrib>Wallace, Chris</creatorcontrib><creatorcontrib>Sinopoulou, Vassiliki</creatorcontrib><creatorcontrib>Gordon, Morris</creatorcontrib><creatorcontrib>Akobeng, Anthony K</creatorcontrib><creatorcontrib>Llanos-Chea, Alejandro</creatorcontrib><creatorcontrib>Hungria, Gregory</creatorcontrib><creatorcontrib>Febo-Rodriguez, Liz</creatorcontrib><creatorcontrib>Fifi, Amanda</creatorcontrib><creatorcontrib>Fernandez Valdes, Lilibet</creatorcontrib><creatorcontrib>Langshaw, Amber</creatorcontrib><creatorcontrib>Saps, Miguel</creatorcontrib><collection>Wiley-Blackwell Cochrane Library</collection><collection>Cochrane Library</collection><collection>Cochrane Library (Open Aceess)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Cochrane database of systematic reviews</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Akobeng, Anthony K</au><au>Wallace, Chris</au><au>Sinopoulou, Vassiliki</au><au>Gordon, Morris</au><au>Akobeng, Anthony K</au><au>Llanos-Chea, Alejandro</au><au>Hungria, Gregory</au><au>Febo-Rodriguez, Liz</au><au>Fifi, Amanda</au><au>Fernandez Valdes, Lilibet</au><au>Langshaw, Amber</au><au>Saps, Miguel</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Probiotics for treatment of chronic constipation in children</atitle><jtitle>Cochrane database of systematic reviews</jtitle><addtitle>Cochrane Database Syst Rev</addtitle><date>2022-03-29</date><risdate>2022</risdate><volume>2022</volume><issue>3</issue><spage>CD014257</spage><pages>CD014257-</pages><issn>1465-1858</issn><issn>1469-493X</issn><eissn>1465-1858</eissn><eissn>1469-493X</eissn><abstract>Background
Functional constipation is defined as chronic constipation with no identifiable underlying cause. It is a significant cause of morbidity in children, accounting for up to 25% of visits to paediatric gastroenterologists. Probiotic preparations may sufficiently alter the gut microbiome and promote normal gut physiology in a way that helps relieve functional constipation. Several studies have sought to address this hypothesis, as well as the role of probiotics in other functional gut disorders. Therefore, it is important to have a focused review to assess the evidence to date.
Objectives
To evaluate the efficacy and safety of probiotics for the management of chronic constipation without a physical explanation in children.
Search methods
On 28 June 2021, we searched CENTRAL, MEDLINE, Embase, CINAHL, AMED, WHO ICTR, and ClinicalTrials.gov, with no language, date, publication status, or document type limitations.
Selection criteria
We included randomised controlled trials (RCTs) that assessed probiotic preparations (including synbiotics) compared to placebo, no treatment or any other interventional preparation in people aged between 0 and 18 years old with a diagnosis of functional constipation according to consensus criteria (such as Rome IV).
Data collection and analysis
We used standard methodological procedures expected by Cochrane.
Main results
We included 14 studies (1127 randomised participants): 12 studies assessed probiotics in the treatment of functional constipation, whilst two studies investigated synbiotic preparations.
Three studies compared probiotics to placebo in relation to the frequency of defecation at study end, but we did not pool them as there was very significant unexplained heterogeneity. Four studies compared probiotics to placebo in relation to treatment success. There may be no difference in global improvement/treatment success (RR 1.29, 95% CI 0.73 to 2.26; 313 participants; low‐certainty evidence). Five studies compared probiotics to placebo in relation to withdrawals due to adverse events, with the pooled effect suggesting there may be no difference (RR 0.64, 95% CI 0.21 to 1.95; 357 participants; low‐certainty evidence).
The pooled estimate from three studies that compared probiotics plus an osmotic laxative to osmotic laxative alone found there may be no difference in frequency of defecation (MD ‐0.01, 95% CI ‐0.57 to 0.56; 268 participants; low‐certainty evidence). Two studies compared probiotics plus an osmotic laxative to osmotic laxative alone in relation to global improvement/treatment success, and found there may be no difference between the treatments (RR 0.95, 95% CI 0.79 to 1.15; 139 participants; low‐certainty evidence). Three studies compared probiotics plus osmotic laxative to osmotic laxative alone in relation to withdrawals due to adverse events, but it is unclear if there is a difference between them (RR 2.86, 95% CI 0.12 to 68.35; 268 participants; very low‐certainty evidence).
Two studies compared probiotics versus magnesium oxide. It is unclear if there is a difference in frequency of defecation (MD 0.28, 95% CI ‐0.58 to 1.14; 36 participants), treatment success (RR 1.08, 95% CI 0.74 to 1.57; 36 participants) or withdrawals due to adverse events (RR 0.50, 95% CI 0.05 to 5.04; 77 participants). The certainty of the evidence is very low for these outcomes.
One study assessed the role of a synbiotic preparation in comparison to placebo. There may be higher treatment success in favour of synbiotics compared to placebo (RR 2.32, 95% CI 1.54 to 3.47; 155 participants; low‐certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group.
One study assessed a synbiotic plus paraffin compared to paraffin alone. It is uncertain if there is a difference in frequency of defecation (MD 0.74, 95% CI ‐0.96, 2.44; 66 participants; very low‐certainty evidence), or treatment success (RR 0.91, 95% CI 0.71 to 1.17; 66 participants; very low‐certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group.
One study compared a synbiotic preparation to paraffin. It is uncertain if there is a difference in frequency of defecation (MD ‐1.53, 95% CI ‐3.00, ‐0.06; 60 participants; very low‐certainty evidence) or in treatment success (RR 0.86, 95% CI 0.65, 1.13; 60 participants; very low‐certainty evidence). The study reported that there were no withdrawals due to adverse effects in either group.
All secondary outcomes were either not reported or reported in a way that did not allow for analysis.
Authors' conclusions
There is insufficient evidence to conclude whether probiotics are efficacious in successfully treating chronic constipation without a physical explanation in children or changing the frequency of defecation, or whether there is a difference in withdrawals due to adverse events when compared with placebo. There is limited evidence from one study to suggest a synbiotic preparation may be more likely than placebo to lead to treatment success, with no difference in withdrawals due to adverse events.
There is insufficient evidence to draw efficacy or safety conclusions about the use of probiotics in combination with or in comparison to any of the other interventions reported. The majority of the studies that presented data on serious adverse events reported that no events occurred. Two studies did not report this outcome.
Future studies are needed to confirm efficacy, but the research community requires guidance on the best context for probiotics in such studies, considering where they should be best considered in a potential treatment hierarchy and should align with core outcome sets to support future interpretation of findings.</abstract><cop>Chichester, UK</cop><pub>John Wiley & Sons, Ltd</pub><pmid>35349168</pmid><doi>10.1002/14651858.CD014257.pub2</doi><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1465-1858 |
| ispartof | Cochrane database of systematic reviews, 2022-03, Vol.2022 (3), p.CD014257 |
| issn | 1465-1858 1469-493X 1465-1858 1469-493X |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8962960 |
| source | MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Cochrane Library; Alma/SFX Local Collection |
| subjects | Adolescent BOWEL Child Child, Preschool Chronic constipation Constipation Constipation - therapy Humans Infant Infant, Newborn Medicine General & Introductory Medical Sciences Probiotics Probiotics - adverse effects Treatment Outcome |
| title | Probiotics for treatment of chronic constipation in children |
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