Clinical trial NCT05900752: A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients
Official title: A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients: A Two-Center, Randomized, Double-Blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Diarrhea
Keywords: Probiotics
QiMeiYan
Lead sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,
Sponsor class: OTHER_GOV
First posted: 2023-06-13
Enrollment: 140
Sex: ALL
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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 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.

Primary outcomes:
measure: Frequency of Diarrhea in IBS-D Patients
timeFrame: baseline day 0, day 28
Secondary outcomes:
measure: Change of Score of IBS-SSS
timeFrame: baseline day 0, day14, day 28
measure: Change of Bristol Stool Scale of the feces
timeFrame: baseline day 0, day 7, day 14, day 21, day 28
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ai'er Hospital
state: Shanghai
city: Chengdu
country: China
facility: Meinian Clinical, Chengdu branch
state: Sichuan
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Ruiming Xu, MD
role: PRINCIPAL_INVESTIGATOR
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