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

Sponsor
Shenzhen Precision Health Food Technology Co. Ltd., (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05900752
Collaborator
(none)
140
Enrollment
2
Locations
2
Arms
1.1
Anticipated Duration (Months)
70
Patients Per Site
60.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: QiMeiYan Probiotics
  • Dietary Supplement: Placebo product
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
A Multi-Strain Probiotic Reduces the Frequency of Diarrhea in IBS-D Patients: A Two-Center, Randomized, Double-Blind, Placebo-controlled Study
Anticipated Study Start Date :
Jun 26, 2023
Anticipated Primary Completion Date :
Jul 23, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Frequency of Diarrhea in IBS-D Patients [baseline day 0, day 28]

    Frequency of Diarrhea in IBS-D Patients for the two groups of participants during the study period

Secondary Outcome Measures

  1. Change of Score of IBS-SSS [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.

  2. Change of Bristol Stool Scale of the feces [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ai'er Hospital Shanghai Shanghai China
2 Meinian Clinical, Chengdu branch Chengdu Sichuan China

Sponsors and Collaborators

  • Shenzhen Precision Health Food Technology Co. Ltd.,

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shenzhen Precision Health Food Technology Co. Ltd.,
ClinicalTrials.gov Identifier:
NCT05900752
Other Study ID Numbers:
  • 23-SM-05-WL-001
First Posted:
Jun 13, 2023
Last Update Posted:
Jun 13, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shenzhen Precision Health Food Technology Co. Ltd.,
Probiotics
QiMeiYan
Additional relevant MeSH terms:
Irritable Bowel Syndrome
Diarrhea

Study Results

No Results Posted as of Jun 13, 2023