A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients

June 2, 2023 updated by: Shenzhen Precision Health Food Technology Co. Ltd.,

A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients: A Two-Center, Randomized, Double-Blind, Placebo-controlled Study

The goal of this interventional clinical study is to study whether the consumption of QiMeiYan Probiotics in 25-35 young people with Mild irritable bowel syndrome (IBS Score 75 - 175) will reduce the frequency of Diarrhea.

140 eligible participants (70 males and 70 females) will be enrolled in two study sites and randomly assigned to two groups of products QiMeiYan Probiotics and placebo. All participants will consume assigned products once a day after meals and record the critical data such as photo of feces. Three site visits will be arranged and all clinical data will be captured and recorded into CTMS (Clinical Trial Management System) for statistical analysis.

Researchers will compare the two groups to validate if the daily consumption of QiMeiYan Probiotics will reduce the frequency of Diarrhea in the study population.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Ai'er Hospital
    • Sichuan

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Chinese males or females, age between 25-35, the ratio is 1:1;
  • Mild irritable bowel syndrome diagnosed by IBS-SSS, IBS Score 75 - 175;
  • Subjects agree not to take any other probiotics during the trial;
  • Willing not to participate in other interventional clinical studies during the period of this trial;
  • Fully understand the purpose, benefits obtained, possible risks and side effects of the study;
  • Willing to comply with all research requirements and procedures;
  • Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate.

Exclusion Criteria:

  • In the treatment of gastrointestinal symptoms;
  • Lactose intolerance;
  • Suffering from other organic diseases currently that affect the intestinal function, such as history, colon or rectal cancer resection of gastrointestinal tract, inflammatory bowel disease, diabetes, thyroid function hyperfunction or decline, congenital megacolon, scleroderma, anorexia, etc.;
  • Controlling diet, exercising more, or taking medications to control weight or affect appetite in the last 3 months;
  • Subjects have any of the following medical history or have been clinically examined to have the following diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases;
  • Abuse alcohol or other drugs, supplement or OTC drugs currently or in the past may cause bowel dysfunction or can affect test result evaluation;
  • Take drugs frequently that may affect gastrointestinal function or the immune system according to PI's judgment;
  • Use laxatives or other substances that promote digestion 2 weeks before the trial;
  • Take dairy products or other foods containing prebiotics/bacteria 10 days before the trial.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: QiMeiYan Probiotics

1.5g/ sachet, containing the following ingredients:

  • Bifidobacterium animalis subsp. lactis V9
  • Lactobacillus casei Zhang
  • Lactobacillus plantarum P-9
  • Lactobacillus plantarum CCFM1143
  • Xylo-oligosaccharide
  • Maltodextrin
  • Resistant Dextrin
  • Blueberry powder
Dietary supplement: QiMeiYan Probiotics
consume one sachet of the assigned product, once a day after meals.
Placebo Comparator: Placebo product

1.5g/sachet, containing the following ingredients:

  • Maltodextrin
  • Blueberry powder
Dietary supplement: Placebo product
consume one sachet of the assigned product, once a day after meals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Diarrhea in IBS-D Patients
Time Frame: baseline day 0, day 28
Frequency of Diarrhea in IBS-D Patients for the two groups of participants during the study period
baseline day 0, day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Score of IBS-SSS
Time Frame: baseline day 0, day14, day 28
Change of Score of IBS-SSS for the two groups of participants during the study period. The score of 75-175 is defined as mild severity, 175-300 as middle level severity and >300 as serious level.
baseline day 0, day14, day 28
Change of Bristol Stool Scale of the feces
Time Frame: baseline day 0, day 7, day 14, day 21, day 28
Change of Bristol Stool Scale (1-7) of the feces for the two groups of participants during the study period. There are 7 types of feces that matches the look and form of bowel movements indicating potential diarrhea or constipation.
baseline day 0, day 7, day 14, day 21, day 28

Collaborators and Investigators

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

Sponsor

Shenzhen Precision Health Food Technology Co. Ltd.,

Investigators

  • Principal Investigator: Ruiming Xu, MD, Shanghai Jiao Tong University School of Medicine

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 (Estimated)

June 26, 2023

Primary Completion (Estimated)

July 23, 2023

Study Completion (Estimated)

July 31, 2023

Study Registration Dates

First Submitted

June 2, 2023

First Submitted That Met QC Criteria

June 2, 2023

First Posted (Actual)

June 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-SM-05-WL-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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