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Clinical Trials/NCT03100851
NCT03100851CompletedPhase 3

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

China Agricultural University0 sites62 target enrollmentStarted: August 2, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
62
Primary Endpoint
change of constipation-related symptom scores
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
China Agricultural University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fazheng Ren

Professor

China Agricultural University

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