PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition (NCT07618000) | Clinical Trial Compass
RecruitingNot Applicable
PI-YSP-0111 Formulation on Human Gut Microbiota and Body Composition
Taiwan140 participantsStarted 2026-04-08
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
9
Sodium (Na⁺)
Timeframe: week0 and week8
10
Potassium (K⁺)
Timeframe: week0 and week8
11
Free Fatty Acids (FFA)
Timeframe: week0 and week8
12
Thyroid Stimulating Hormone (TSH)
Timeframe: week0 and week8
13
white blood cell (WBC) count/automated differential
Timeframe: week0 and week8
14
red blood cell (RBC) count
Timeframe: week0 and week8
15
hemoglobin
Timeframe: week0 and week8
16
hematocrit
Timeframe: week0 and week8
17
platelet count
Timeframe: week0 and week8
18
mean corpuscular volume (M.C.V)
Timeframe: week0 and week8
19
mean corpuscular hemoglobin concentration (M.C.H.C)