Effect of Probiotic on Constipation

June 28, 2017 updated by: Fazheng Ren, China Agricultural University

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LcS intervention
Patients with constipation received dietary supplement with Lactobacaiilus casei strain Shirota.
Dietary supplement: Lactobacillus casei strain Shirota
a bottle of 100 mililiter probiotic dairy beverage containing 10^8 CFU Lactobacillus casei strain Shirota every day after lunch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of stool consistency
Time Frame: change from baseline stool consistency at four-week intervention
change from baseline stool consistency at four-week intervention
change of defecation frequency
Time Frame: change from baseline defecation frequency at four-week intervention
change from baseline defecation frequency at four-week intervention
change of constipation-related symptom scores
Time Frame: change from baseline constipation-related symptom scores at four-week intervention
change from baseline constipation-related symptom scores at four-week intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in stool short chain fatty acid content
Time Frame: change from baseline stool short chain fatty acid content at four-week intervention
change from baseline stool short chain fatty acid content at four-week intervention
Changes in gut microbiota
Time Frame: change from baseline gut microbiota at four-week intervention
change from baseline gut microbiota at four-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Agricultural University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 2, 2015

Primary Completion (ACTUAL)

September 26, 2016

Study Completion (ACTUAL)

March 17, 2017

Study Registration Dates

First Submitted

March 29, 2017

First Submitted That Met QC Criteria

March 29, 2017

First Posted (ACTUAL)

April 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 29, 2017

Last Update Submitted That Met QC Criteria

June 28, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAUConstipation-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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