Effect of Fermented Milk Containing Lactobacillus Casei Strain Shirota on Chinese People With Constipation

China Agricultural University0 sites62 target enrollmentAugust 2, 2015

ConditionsConstipation

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Constipation
Sponsor: China Agricultural University
Enrollment: 62
Primary Endpoint: change of constipation-related symptom scores
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2, 2015

End Date

March 17, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

China Agricultural University

Responsible Party

Principal Investigator

Fazheng Ren

Professor

China Agricultural University

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.

Outcomes

Primary Outcomes

change of constipation-related symptom scores

Time Frame: change from baseline constipation-related symptom scores at four-week intervention

change of stool consistency

Time Frame: change from baseline stool consistency at four-week intervention

change of defecation frequency

Time Frame: change from baseline defecation frequency at four-week intervention

Secondary Outcomes

Changes in stool short chain fatty acid content(change from baseline stool short chain fatty acid content at four-week intervention)
Changes in gut microbiota(change from baseline gut microbiota at four-week intervention)