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

Exclusion Criteria10

• 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.