Probiotics for Constipation in Parkinson Disease: A Randomized Placebo-Controlled Study
To determine whether probiotics are effective for constipation, a common and often difficult-to-treat problem, in Parkinson disease (PD). In this double-blind, randomized, placebo-controlled, single-center trial, 280 patients with PD were screened, and 72 eligible patients were block-randomized (1:1...
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| Veröffentlicht in: | Neurology 2021-02, Vol.96 (5), p.e772-e782 |
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| creator | Tan, Ai Huey Lim, Shen-Yang Chong, Kah Kian A Manap, Mohammad Addin Azhan Hor, Jia Wei Lim, Jia Lun Low, Soon Chai Chong, Chun Wie Mahadeva, Sanjiv Lang, Anthony E. |
| description | To determine whether probiotics are effective for constipation, a common and often difficult-to-treat problem, in Parkinson disease (PD).
In this double-blind, randomized, placebo-controlled, single-center trial, 280 patients with PD were screened, and 72 eligible patients were block-randomized (1:1) to receive either multistrain probiotics capsules (n = 34) or identical-appearing placebo (n = 38), for 4 weeks. The primary endpoint was the change in the average number of spontaneous bowel movements (SBM) per week during the last 2 weeks of intervention compared with the 2-week preintervention phase, recorded by daily stool diary. Secondary outcome measures included changes in stool consistency, constipation severity score, and quality of life related to constipation. Satisfaction with intervention received was assessed. Change in levels of fecal calprotectin, a marker of intestinal inflammation, was an exploratory outcome.
SBM increased by 1.0 ± 1.2 per week after treatment with probiotics and decreased by 0.3 ± 1.0 per week in the placebo group (mean difference 1.3, 95% confidence interval 0.8-1.8,
< 0.001). Significant improvements were also seen for secondary outcomes after correction for multiple comparisons, including stool consistency (
= 0.009) and quality of life related to constipation (
= 0.001). In the treatment group, 65.6% reported satisfaction with the intervention vs only 21.6% in the placebo group (
< 0.001). One patient (2.9%) in the treatment group withdrew due to a nonserious adverse event. Fecal calprotectin did not change significantly during the study.
Multistrain probiotics treatment was effective for constipation in PD. Further studies are needed to investigate the long-term efficacy and safety of probiotics in PD, as well as their mechanisms of action.
NCT03377322.
This study provides Class I evidence that, for people with PD, multistrain probiotics significantly increased the average number of SBM per week. |
| doi_str_mv | 10.1212/WNL.0000000000010998 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2450668509</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2450668509</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3525-86ec63ed83316881680b7f4994b7d745ca1baf3fb8b8540208004eb41e6963f93</originalsourceid><addsrcrecordid>eNpdkFtr3DAQhUVJaTZJ_0EIfsyLt6Or5byFTZoWlnbJhfTNSPaYVaK1NpLNkv76epNtFzowDBrOOYM-Qk4pTCmj7Mvjj_kU9kWhLPUHMqGSqVxx9uuATACYzrku9CE5SulpFElWlJ_IIecglIJiQh4XMVgXelenrA0xm4Uu9W5tehe6zHXZwsRn16XxceUSmoQX2WV2a7omrNxvbLKFNzXakI--Pgbvx9VdPzSvJ-Rja3zCz7t5TB6-Xt_PvuXznzffZ5fzvOaSyVwrrBXHRnNOldZjgy1aUZbCFk0hZG2oNS1vrbZaCmCgAQRaQVGVirclPybn77nrGF4GTH21cqlG702HYUgVExKU0hK2UvEurWNIKWJbraNbmfhaUai2SKsRafU_0tF2trsw2BU2_0x_Ge5zN8H3GNOzHzYYqyUa3y_f8hSlImfA6PgBBvk2WvI_kcqAPg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2450668509</pqid></control><display><type>article</type><title>Probiotics for Constipation in Parkinson Disease: A Randomized Placebo-Controlled Study</title><source>MEDLINE</source><source>Journals@Ovid Complete</source><source>Alma/SFX Local Collection</source><creator>Tan, Ai Huey ; Lim, Shen-Yang ; Chong, Kah Kian ; A Manap, Mohammad Addin Azhan ; Hor, Jia Wei ; Lim, Jia Lun ; Low, Soon Chai ; Chong, Chun Wie ; Mahadeva, Sanjiv ; Lang, Anthony E.</creator><creatorcontrib>Tan, Ai Huey ; Lim, Shen-Yang ; Chong, Kah Kian ; A Manap, Mohammad Addin Azhan ; Hor, Jia Wei ; Lim, Jia Lun ; Low, Soon Chai ; Chong, Chun Wie ; Mahadeva, Sanjiv ; Lang, Anthony E.</creatorcontrib><description>To determine whether probiotics are effective for constipation, a common and often difficult-to-treat problem, in Parkinson disease (PD).
In this double-blind, randomized, placebo-controlled, single-center trial, 280 patients with PD were screened, and 72 eligible patients were block-randomized (1:1) to receive either multistrain probiotics capsules (n = 34) or identical-appearing placebo (n = 38), for 4 weeks. The primary endpoint was the change in the average number of spontaneous bowel movements (SBM) per week during the last 2 weeks of intervention compared with the 2-week preintervention phase, recorded by daily stool diary. Secondary outcome measures included changes in stool consistency, constipation severity score, and quality of life related to constipation. Satisfaction with intervention received was assessed. Change in levels of fecal calprotectin, a marker of intestinal inflammation, was an exploratory outcome.
SBM increased by 1.0 ± 1.2 per week after treatment with probiotics and decreased by 0.3 ± 1.0 per week in the placebo group (mean difference 1.3, 95% confidence interval 0.8-1.8,
< 0.001). Significant improvements were also seen for secondary outcomes after correction for multiple comparisons, including stool consistency (
= 0.009) and quality of life related to constipation (
= 0.001). In the treatment group, 65.6% reported satisfaction with the intervention vs only 21.6% in the placebo group (
< 0.001). One patient (2.9%) in the treatment group withdrew due to a nonserious adverse event. Fecal calprotectin did not change significantly during the study.
Multistrain probiotics treatment was effective for constipation in PD. Further studies are needed to investigate the long-term efficacy and safety of probiotics in PD, as well as their mechanisms of action.
NCT03377322.
This study provides Class I evidence that, for people with PD, multistrain probiotics significantly increased the average number of SBM per week.</description><identifier>ISSN: 0028-3878</identifier><identifier>EISSN: 1526-632X</identifier><identifier>DOI: 10.1212/WNL.0000000000010998</identifier><identifier>PMID: 33046607</identifier><language>eng</language><publisher>United States: Lippincott Williams & Wilkins</publisher><subject>Aged ; Constipation - etiology ; Constipation - physiopathology ; Constipation - therapy ; Double-Blind Method ; Feces - chemistry ; Female ; Humans ; Leukocyte L1 Antigen Complex - metabolism ; Male ; Middle Aged ; Parkinson Disease - complications ; Parkinson Disease - physiopathology ; Patient Satisfaction ; Probiotics - therapeutic use ; Quality of Life</subject><ispartof>Neurology, 2021-02, Vol.96 (5), p.e772-e782</ispartof><rights>Lippincott Williams & Wilkins</rights><rights>2020 American Academy of Neurology.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3525-86ec63ed83316881680b7f4994b7d745ca1baf3fb8b8540208004eb41e6963f93</citedby><cites>FETCH-LOGICAL-c3525-86ec63ed83316881680b7f4994b7d745ca1baf3fb8b8540208004eb41e6963f93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33046607$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Tan, Ai Huey</creatorcontrib><creatorcontrib>Lim, Shen-Yang</creatorcontrib><creatorcontrib>Chong, Kah Kian</creatorcontrib><creatorcontrib>A Manap, Mohammad Addin Azhan</creatorcontrib><creatorcontrib>Hor, Jia Wei</creatorcontrib><creatorcontrib>Lim, Jia Lun</creatorcontrib><creatorcontrib>Low, Soon Chai</creatorcontrib><creatorcontrib>Chong, Chun Wie</creatorcontrib><creatorcontrib>Mahadeva, Sanjiv</creatorcontrib><creatorcontrib>Lang, Anthony E.</creatorcontrib><title>Probiotics for Constipation in Parkinson Disease: A Randomized Placebo-Controlled Study</title><title>Neurology</title><addtitle>Neurology</addtitle><description>To determine whether probiotics are effective for constipation, a common and often difficult-to-treat problem, in Parkinson disease (PD).
In this double-blind, randomized, placebo-controlled, single-center trial, 280 patients with PD were screened, and 72 eligible patients were block-randomized (1:1) to receive either multistrain probiotics capsules (n = 34) or identical-appearing placebo (n = 38), for 4 weeks. The primary endpoint was the change in the average number of spontaneous bowel movements (SBM) per week during the last 2 weeks of intervention compared with the 2-week preintervention phase, recorded by daily stool diary. Secondary outcome measures included changes in stool consistency, constipation severity score, and quality of life related to constipation. Satisfaction with intervention received was assessed. Change in levels of fecal calprotectin, a marker of intestinal inflammation, was an exploratory outcome.
SBM increased by 1.0 ± 1.2 per week after treatment with probiotics and decreased by 0.3 ± 1.0 per week in the placebo group (mean difference 1.3, 95% confidence interval 0.8-1.8,
< 0.001). Significant improvements were also seen for secondary outcomes after correction for multiple comparisons, including stool consistency (
= 0.009) and quality of life related to constipation (
= 0.001). In the treatment group, 65.6% reported satisfaction with the intervention vs only 21.6% in the placebo group (
< 0.001). One patient (2.9%) in the treatment group withdrew due to a nonserious adverse event. Fecal calprotectin did not change significantly during the study.
Multistrain probiotics treatment was effective for constipation in PD. Further studies are needed to investigate the long-term efficacy and safety of probiotics in PD, as well as their mechanisms of action.
NCT03377322.
This study provides Class I evidence that, for people with PD, multistrain probiotics significantly increased the average number of SBM per week.</description><subject>Aged</subject><subject>Constipation - etiology</subject><subject>Constipation - physiopathology</subject><subject>Constipation - therapy</subject><subject>Double-Blind Method</subject><subject>Feces - chemistry</subject><subject>Female</subject><subject>Humans</subject><subject>Leukocyte L1 Antigen Complex - metabolism</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Parkinson Disease - complications</subject><subject>Parkinson Disease - physiopathology</subject><subject>Patient Satisfaction</subject><subject>Probiotics - therapeutic use</subject><subject>Quality of Life</subject><issn>0028-3878</issn><issn>1526-632X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpdkFtr3DAQhUVJaTZJ_0EIfsyLt6Or5byFTZoWlnbJhfTNSPaYVaK1NpLNkv76epNtFzowDBrOOYM-Qk4pTCmj7Mvjj_kU9kWhLPUHMqGSqVxx9uuATACYzrku9CE5SulpFElWlJ_IIecglIJiQh4XMVgXelenrA0xm4Uu9W5tehe6zHXZwsRn16XxceUSmoQX2WV2a7omrNxvbLKFNzXakI--Pgbvx9VdPzSvJ-Rja3zCz7t5TB6-Xt_PvuXznzffZ5fzvOaSyVwrrBXHRnNOldZjgy1aUZbCFk0hZG2oNS1vrbZaCmCgAQRaQVGVirclPybn77nrGF4GTH21cqlG702HYUgVExKU0hK2UvEurWNIKWJbraNbmfhaUai2SKsRafU_0tF2trsw2BU2_0x_Ge5zN8H3GNOzHzYYqyUa3y_f8hSlImfA6PgBBvk2WvI_kcqAPg</recordid><startdate>20210202</startdate><enddate>20210202</enddate><creator>Tan, Ai Huey</creator><creator>Lim, Shen-Yang</creator><creator>Chong, Kah Kian</creator><creator>A Manap, Mohammad Addin Azhan</creator><creator>Hor, Jia Wei</creator><creator>Lim, Jia Lun</creator><creator>Low, Soon Chai</creator><creator>Chong, Chun Wie</creator><creator>Mahadeva, Sanjiv</creator><creator>Lang, Anthony E.</creator><general>Lippincott Williams & Wilkins</general><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></search><sort><creationdate>20210202</creationdate><title>Probiotics for Constipation in Parkinson Disease: A Randomized Placebo-Controlled Study</title><author>Tan, Ai Huey ; Lim, Shen-Yang ; Chong, Kah Kian ; A Manap, Mohammad Addin Azhan ; Hor, Jia Wei ; Lim, Jia Lun ; Low, Soon Chai ; Chong, Chun Wie ; Mahadeva, Sanjiv ; Lang, Anthony E.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3525-86ec63ed83316881680b7f4994b7d745ca1baf3fb8b8540208004eb41e6963f93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Aged</topic><topic>Constipation - etiology</topic><topic>Constipation - physiopathology</topic><topic>Constipation - therapy</topic><topic>Double-Blind Method</topic><topic>Feces - chemistry</topic><topic>Female</topic><topic>Humans</topic><topic>Leukocyte L1 Antigen Complex - metabolism</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Parkinson Disease - complications</topic><topic>Parkinson Disease - physiopathology</topic><topic>Patient Satisfaction</topic><topic>Probiotics - therapeutic use</topic><topic>Quality of Life</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Tan, Ai Huey</creatorcontrib><creatorcontrib>Lim, Shen-Yang</creatorcontrib><creatorcontrib>Chong, Kah Kian</creatorcontrib><creatorcontrib>A Manap, Mohammad Addin Azhan</creatorcontrib><creatorcontrib>Hor, Jia Wei</creatorcontrib><creatorcontrib>Lim, Jia Lun</creatorcontrib><creatorcontrib>Low, Soon Chai</creatorcontrib><creatorcontrib>Chong, Chun Wie</creatorcontrib><creatorcontrib>Mahadeva, Sanjiv</creatorcontrib><creatorcontrib>Lang, Anthony E.</creatorcontrib><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><jtitle>Neurology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Tan, Ai Huey</au><au>Lim, Shen-Yang</au><au>Chong, Kah Kian</au><au>A Manap, Mohammad Addin Azhan</au><au>Hor, Jia Wei</au><au>Lim, Jia Lun</au><au>Low, Soon Chai</au><au>Chong, Chun Wie</au><au>Mahadeva, Sanjiv</au><au>Lang, Anthony E.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Probiotics for Constipation in Parkinson Disease: A Randomized Placebo-Controlled Study</atitle><jtitle>Neurology</jtitle><addtitle>Neurology</addtitle><date>2021-02-02</date><risdate>2021</risdate><volume>96</volume><issue>5</issue><spage>e772</spage><epage>e782</epage><pages>e772-e782</pages><issn>0028-3878</issn><eissn>1526-632X</eissn><abstract>To determine whether probiotics are effective for constipation, a common and often difficult-to-treat problem, in Parkinson disease (PD).
In this double-blind, randomized, placebo-controlled, single-center trial, 280 patients with PD were screened, and 72 eligible patients were block-randomized (1:1) to receive either multistrain probiotics capsules (n = 34) or identical-appearing placebo (n = 38), for 4 weeks. The primary endpoint was the change in the average number of spontaneous bowel movements (SBM) per week during the last 2 weeks of intervention compared with the 2-week preintervention phase, recorded by daily stool diary. Secondary outcome measures included changes in stool consistency, constipation severity score, and quality of life related to constipation. Satisfaction with intervention received was assessed. Change in levels of fecal calprotectin, a marker of intestinal inflammation, was an exploratory outcome.
SBM increased by 1.0 ± 1.2 per week after treatment with probiotics and decreased by 0.3 ± 1.0 per week in the placebo group (mean difference 1.3, 95% confidence interval 0.8-1.8,
< 0.001). Significant improvements were also seen for secondary outcomes after correction for multiple comparisons, including stool consistency (
= 0.009) and quality of life related to constipation (
= 0.001). In the treatment group, 65.6% reported satisfaction with the intervention vs only 21.6% in the placebo group (
< 0.001). One patient (2.9%) in the treatment group withdrew due to a nonserious adverse event. Fecal calprotectin did not change significantly during the study.
Multistrain probiotics treatment was effective for constipation in PD. Further studies are needed to investigate the long-term efficacy and safety of probiotics in PD, as well as their mechanisms of action.
NCT03377322.
This study provides Class I evidence that, for people with PD, multistrain probiotics significantly increased the average number of SBM per week.</abstract><cop>United States</cop><pub>Lippincott Williams & Wilkins</pub><pmid>33046607</pmid><doi>10.1212/WNL.0000000000010998</doi></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0028-3878 |
| ispartof | Neurology, 2021-02, Vol.96 (5), p.e772-e782 |
| issn | 0028-3878 1526-632X |
| language | eng |
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| source | MEDLINE; Journals@Ovid Complete; Alma/SFX Local Collection |
| subjects | Aged Constipation - etiology Constipation - physiopathology Constipation - therapy Double-Blind Method Feces - chemistry Female Humans Leukocyte L1 Antigen Complex - metabolism Male Middle Aged Parkinson Disease - complications Parkinson Disease - physiopathology Patient Satisfaction Probiotics - therapeutic use Quality of Life |
| title | Probiotics for Constipation in Parkinson Disease: A Randomized Placebo-Controlled Study |
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