PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Heathly Volunteers

In brief

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.

Key facts

Study ID

NCT07618000

Run by

Taipei Medical University

People needed

140

Starts

2026-04-08

Expected to finish

2027-04-07

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy males or females aged 18 to 65 years.
• BMI between 23.0 and 40.0 kg/m².
• Waist circumference: ≥ 90 cm for males and ≥ 80 cm for females.
• 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.
• Participants have fully understood the study procedures and have signed the informed consent form.

You may not qualify if…

• Presence of gastrointestinal diseases, such as inflammatory bowel disease, irritable bowel syndrome, gastroesophageal reflux disease, Crohn's disease, or a history of bariatric surgery.
• 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]).
• Exposure to unapproved medications, alcohol abuse, or substance abuse.
• 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).
• Short-term use of corticosteroids, nonsteroidal anti-inflammatory drugs, immunosuppressive agents, interferons, or immunomodulatory agents within the past one month.
• Use of any weight-loss medications (including oral agents, injections, or traditional Chinese medicine) within the past three months.
• Participation in any other interventional clinical study within the past one month.
• History of cancer or current malignancy within the past two years, except for non-melanoma skin cancer.
• Occurrence of major trauma or any surgical procedures within the past one month.
• History of diabetic ketoacidosis.

Where it is running

• Taipei Medical University — Taipei, Taiwan, Taiwan (enrolling)
• Taipei Municipal WanFang Hospital(Managed by Taipei Medical University) — Taipei, Taiwan, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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