Probiotic treatment to improve gut function
A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Effect of Probiotics on Gut Function in Healthy Chinese Adults
This study tests if taking probiotics can help healthy adults aged 18 to 65 improve their gut health and bowel habits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Probi AB Industry-sponsored |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05155449 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of probiotics on gut function in healthy individuals aged 18 to 65. Participants will be randomly assigned to receive either probiotics or a placebo while maintaining their usual dietary and lifestyle habits. The study aims to assess changes in bowel habits and overall gut health over the intervention period. The focus is on individuals who experience dissatisfaction with their bowel movements and have frequent stools.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 65 with a BMI between 18.5 and 27.9 who experience frequent stools and are dissatisfied with their bowel habits.
Not a fit: Patients suffering from IBS, chronic intestinal diseases, or significant constipation or diarrhea may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved gut health and bowel function for individuals experiencing digestive issues.
How similar studies have performed: Previous studies have shown promising results with probiotic interventions for gut health, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 65 years * BMI between 18.5 and 27.9 kg/m² * Subjects having ≥ 3 bowel movements per day * Subject not satisfied with their bowel habits * Subject having frequent stools during more than 4 weeks * For women: Non menopausal with the same reliable contraception since at least 3 cycles before the beginning of the study and agreeing to keep it during the entire duration of the study * Subjects agreeing to keep their dietary and life habits unchanged throughout the study * Good general and mental health within the opinion of the investigator * Able and willing to participate to the study by complying with the protocol procedures as evidenced by a dated and signed ICF Exclusion Criteria: * Suffering IBS according to Rome IV criteria, chronic intestinal disease, immunodeficiency disorder or immunosuppressive treatment * Clinically significant frequent constipation or diarrhea at the screening visit as judged by the Investigator * Suffering from a severe chronic disease or GI disorders found to be inconsistent with the conduct of the study by the investigator * Intake of antibiotics within 8 weeks prior to the start of the study * With regular intake of probiotics within four weeks prior to V1 visit * Under treatment or dietary supplement which could significantly affect parameter(s) followed during the study according to the investigator or stopped in a too short period before the V1 visit * Suspected alcohol or substance abuse * Use of medications other than contraceptives or prescribed medication after consulting with the investigator * History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk if participating in the study, or influence the results or the subject´s ability to participate in the study * With a known gluten intolerance, milk protein allergy * With a known or suspected food allergy or intolerance or hypersensitivity to any of the study products' ingredients * Pregnant or lactating women or intending to become pregnant within 3 months ahead * With significant change in food habits or in physical activity in the 3 months before the V1 visit * With a personal history of anorexia nervosa, bulimia or significant eating disorders according to the investigator * Having a lifestyle deemed incompatible with the study according to the investigator * Currently participating in another clinical study, has done so in the past 30 days or being in the exclusion period of a previous clinical trial * Under legal protection (guardianship, wardship) or deprived from his/her rights following administrative or judicial decision * Presenting a psychological or linguistic incapability to sign the informed consent or Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements * Impossible to contact in case of emergency
Where this trial is running
Shanghai
- Shanghai 9th People's Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xiangjun Meng, MD — Shanghai 9th People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Study coordinator: Xiangjun Meng, MD
- Email: xiangjunmeng@aliyun.com
- Phone: +86 021-53315134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.