NCT07618000 PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition
| NCT ID | NCT07618000 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Taipei Medical University |
| Condition | Heathly Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2027-04-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2026-04-08 with a primary completion date of 2027-04-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The expected outcome of this study is that continuous 8-week supplementation with the PI-YSP-0111 prebiotic formulation will exert beneficial effects on gut microbiota modulation and liver health.
Eligibility Criteria
Inclusion Criteria: 1. Healthy males or females aged 18 to 65 years. 2. BMI between 23.0 and 40.0 kg/m². 3. Waist circumference: ≥ 90 cm for males and ≥ 80 cm for females. 4. Participants are willing to maintain their usual dietary habits, daily routines, and physical activity levels during the study period, and have no plans to relocate. 5. Participants have fully understood the study procedures and have signed the informed consent form. Exclusion Criteria: 1. Presence of gastrointestinal diseases, such as inflammatory bowel disease, irritable bowel syndrome, gastroesophageal reflux disease, Crohn's disease, or a history of bariatric surgery. 2. Recent history of acute gastroenteritis, constipation or diarrhea; psychiatric disorders (e.g., depression or schizophrenia); cardiovascular diseases (e.g., hypertension); known allergy or hypersensitivity to the investigational product; extreme dietary habits; significant body weight change (\>4.5 kg) within the past three months; recent use of antibiotics or antifungal agents; or use of medications affecting gastrointestinal function (such as probiotics, laxatives, or nonsteroidal anti-inflammatory drugs \[NSAIDs\]). 3. Exposure to unapproved medications, alcohol abuse, or substance abuse. 4. Female-specific conditions, including significant gastrointestinal symptoms during menstruation, irregular menstrual cycles, pregnancy, planned pregnancy, or breastfeeding (participants who become pregnant during the study period will also be excluded). 5. Short-term use of corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressive agents, interferons, or immunomodulatory agents within the past one month. 6. Use of any weight-loss medications (including oral agents, injections, or traditional Chinese medicine) within the past three months. 7. Participation in any other interventional clinical study within the past one month. 8. History of cancer or current malignancy within the past two years, except for non-melanoma skin cancer. 9. Occurrence of major trauma or any surgical procedures within the past one month. 10. History of diabetic ketoacidosis.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07618000 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Heathly Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07618000 currently recruiting?
Yes, NCT07618000 is actively recruiting participants. Contact the research team at yangrugby@tmu.edu.tw for enrollment information.
Where is the NCT07618000 trial being conducted?
This trial is being conducted at Taipei, Taiwan, Taipei, Taiwan.
Who is sponsoring the NCT07618000 clinical trial?
NCT07618000 is sponsored by Taipei Medical University. The trial plans to enroll 140 participants.