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
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
ChinaSite Not Available
Meinian Clinical, Chengdu branch
Chengdu, Sichuan
ChinaSite Not Available

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