Impact of Akkermansia Muciniphila on obesity and metabolic health

Safety and Tolerability Evaluation of Heat-Inactivated Akkermansia Muciniphila Akk11: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

This study is testing if a probiotic called Akkermansia muciniphila can help adults with obesity improve their weight and overall health compared to a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Wecare Probiotics Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Jakarta Pusat, Jakarta Special Capital Region)
• Trial ID: NCT06728098 on ClinicalTrials.gov

What this trial studies

This randomized, double-blinded, placebo-controlled study evaluates the efficacy and safety of the probiotic Akkermansia muciniphila Akk11 in adults with obesity. Participants will be assigned to receive either the probiotic or a placebo to assess its impact on weight and metabolic health. The study aims to determine if this intervention can lead to significant improvements in obesity-related health metrics. The trial will include both healthy individuals and those classified as obese, ensuring a diverse participant pool.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-50 with a BMI of 30 kg/m2 or higher who are stable in weight.

Not a fit: Patients with a BMI below 30 kg/m2 or those with significant metabolic disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel probiotic treatment option for managing obesity and improving metabolic health.

How similar studies have performed: While the use of probiotics for obesity management is an emerging field, this specific approach with Akkermansia muciniphila is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Male or Female subject age 18-60 years at screening.
2. Healthy subject according to investigator judgement based on screening data.
3. Subjects must be either of non-childbearing potential, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for the entire study.
4. Subjects who have not smoked in the past 1 month prior to screening.
5. Subjects with a healthy and balanced diet, including adequate fiber intake in their food consumption.
6. Subject or subject's legally acceptable representatives have the ability to comply with the trial protocol.
7. Signed informed consent from the subject or subject's legally acceptable representatives (must be obtained before any trial related activities).

Exclusion Criteria:

1. History of or presence of diabetes, immunodeficiency disorders, or chronic illness.
2. Regular use of medications known to affect the gastrointestinal system or alter gut microbiota composition, including but not limited to antibiotics, and immunosuppressants.
3. Have continuous, daily use of probiotics or probiotic containing products within 1 month prior to randomization.
4. Pregnant, planning a pregnancy or lactating female (urinary pregnancy test will be applied to female subjects at screening).
5. Change type of diet during study.
6. Any known allergy or intolerance to any of the ingredients in the formulation of the product under study.
7. History of drug, alcohol or other substance abuse, or other factors that limit their ability to cooperate during the study.
8. History of or presence of eating disorder.
9. Subject whose condition does not make them eligible to the study, according to the investigator.

Where this trial is running

Jakarta Pusat, Jakarta Special Capital Region

• Fakultas Kedokteran Universitas Indonesia — Jakarta Pusat, Jakarta Special Capital Region, Indonesia (Recruiting)

Study contacts

• Study coordinator: Vicky Achmad Ginanjar, bachelor

Conditions Healthy