Probiotics in Obesity Management

Launched by WECARE PROBIOTICS CO., LTD. · May 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special type of bacteria called Akkermansia muciniphila, which has been pasteurized (killed) and is given in capsule form, to see if it can help with weight management in overweight or obese adults. The researchers want to find out if taking these capsules can change important health measurements like weight, body fat percentage, and cholesterol levels compared to a placebo, which is a harmless pill that does not contain the active ingredient.

To participate, individuals need to have a body mass index (BMI) of 25 or higher, meaning they are considered overweight or obese. They also need to agree to follow a specific diet and use effective contraception if they are women of childbearing age. Some people may not be eligible, such as those with certain medical conditions, recent antibiotic use, or who are pregnant or breastfeeding. If someone joins the study, they can expect to take the capsules regularly and attend follow-up visits to monitor their health and progress throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. A body mass index (BMI) of 25 kg/m² or above;
• • 2. Voluntarily signing an informed consent form to take part in the study;
• • 3. Willingness to undertake the study protocol and associated restrictions, such as adhering to a calorie - restricted - low carbohydrate diet;
• • 4. No intention to become pregnant from 14 days before screening, and commitment to using effective contraception until six months after the trial concludes.
• Exclusion Criteria:
• • 1. Intake of products akin to the test product in the recent period that might sway the outcomes;
• • 2. Presence of mental or neurological disorders, celiac disease, lactose intolerance, or allergic conditions;
• • 3. Being pregnant, breastfeeding, or planning to conceive;
• • 4. Past diagnosis of Irritable Bowel Syndrome, Ulcerative Colitis, Hepatic Cirrhosis, or Diabetes Mellitus;
• • 5. Use of antibiotics in the preceding three months;
• • 6. Inability to comply with the test product regimen or attend follow-up visits regularly, making efficacy assessment unfeasible;
• • 7. Smoking in excess of 10 cigarettes daily;
• • 8. Hypersensitivity to probiotic products;
• • 9. Any other participants deemed unsuitable for the research by the investigator.