Safety and Tolerability Evaluation of Akkermansia Muciniphila
Safety and Tolerability Evaluation of Heat-Inactivated Akkermansia Muciniphila Akk11: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Wecare Probiotics Co., Ltd.
108 participants
Nov 25, 2025
INTERVENTIONAL
Conditions
Summary
This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in healthy adult.
Eligibility
Inclusion Criteria7
- Male or Female subject age 18-60 years at screening.
- Healthy subject according to investigator judgement based on screening data.
- 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.
- Subjects who have not smoked in the past 1 month prior to screening.
- Subjects with a healthy and balanced diet, including adequate fiber intake in their food consumption.
- Subject or subject's legally acceptable representatives have the ability to comply with the trial protocol.
- Signed informed consent from the subject or subject's legally acceptable representatives (must be obtained before any trial related activities).
Exclusion Criteria9
- History of or presence of diabetes, immunodeficiency disorders, or chronic illness.
- Regular use of medications known to affect the gastrointestinal system or alter gut microbiota composition, including but not limited to antibiotics, and immunosuppressants.
- Have continuous, daily use of probiotics or probiotic containing products within 1 month prior to randomization.
- Pregnant, planning a pregnancy or lactating female (urinary pregnancy test will be applied to female subjects at screening).
- Change type of diet during study.
- Any known allergy or intolerance to any of the ingredients in the formulation of the product under study.
- History of drug, alcohol or other substance abuse, or other factors that limit their ability to cooperate during the study.
- History of or presence of eating disorder.
- Subject whose condition does not make them eligible to the study, according to the investigator.
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Interventions
The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).
The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06728098