Clinical trial NCT03100851: Effect of Probiotic on Constipation
Official title: Effect of Fermented Milk Containing Lactobacillus Casei Strain Shirota on Chinese People With Constipation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Lead sponsor: China Agricultural University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Constipation is a prevalent intestinal disorder. Lactobacillus casei strain Shirota (LcS) shows potential effect on alleviating constipation. This study evaluated the impact of fermented milk containing LcS on stool consistency and frequency. The stool short chain fatty acid and gut microbiota were also assessed.


Eligibility criteria: Inclusion Criteria:

* meet ROME Ⅲ criteria for functional constipation
* normal body mass index between 18.5 and 29.9

Exclusion Criteria:

* had a serious disease;
* used systemic antibiotics or antimycotics medication and antidiarrheal or laxative medication in the 30 days prior to the study;
* allergic to milk protein;
* constipated because of organic or neurological lesions;
* participated in any other studies within 2 months prior to this study.

Primary outcomes:
measure: change of stool consistency
timeFrame: change from baseline stool consistency at four-week intervention
measure: change of defecation frequency
timeFrame: change from baseline defecation frequency at four-week intervention
measure: change of constipation-related symptom scores
timeFrame: change from baseline constipation-related symptom scores at four-week intervention
Secondary outcomes:
measure: Changes in stool short chain fatty acid content
timeFrame: change from baseline stool short chain fatty acid content at four-week intervention
measure: Changes in gut microbiota
timeFrame: change from baseline gut microbiota at four-week intervention
Other outcomes:
Locations:
Study officials:
References:
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citation: Dimidi E, Christodoulides S, Fragkos KC, Scott SM, Whelan K. The effect of probiotics on functional constipation in adults: a systematic review and meta-analysis of randomized controlled trials. Am J Clin Nutr. 2014 Oct;100(4):1075-84. doi: 10.3945/ajcn.114.089151. Epub 2014 Aug 6.
citation: Koebnick C, Wagner I, Leitzmann P, Stern U, Zunft HJ. Probiotic beverage containing Lactobacillus casei Shirota improves gastrointestinal symptoms in patients with chronic constipation. Can J Gastroenterol. 2003 Nov;17(11):655-9. doi: 10.1155/2003/654907.