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

Last updated: November 21, 2023
Sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,
Overall Status: Completed

Phase

N/A

Condition

Lactose Intolerance

Colic

Hyponatremia

Treatment

QiMeiYan Probiotics

Placebo product

Clinical Study ID

NCT05900752
23-SM-05-WL-001
  • Ages 25-35
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 periodof this trial;
  • Fully understand the purpose, benefits obtained, possible risks and side effects ofthe study;
  • Willing to comply with all research requirements and procedures;
  • Understand the test procedure, read, and sign an appropriate Informed Consent Formindicating their willingness to participate.

Exclusion

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 affectappetite in the last 3 months;
  • Subjects have any of the following medical history or have been clinically examined tohave the following diseases that may affect the evaluation of the test effect: obviousgastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory andcardiovascular diseases;
  • Abuse alcohol or other drugs, supplement or OTC drugs currently or in the past maycause bowel dysfunction or can affect test result evaluation;
  • Take drugs frequently that may affect gastrointestinal function or the immune systemaccording 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 thetrial.

Study Design

Total Participants: 140
Treatment Group(s): 2
Primary Treatment: QiMeiYan Probiotics
Phase:
Study Start date:
June 19, 2023
Estimated Completion Date:
July 16, 2023

Connect with a study center

  • Ai'er Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • Meinian Clinical, Chengdu branch

    Chengdu, Sichuan
    China

    Site Not Available

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