Safety and Tolerability Evaluation of Akkermansia Muciniphila

Not Applicable

Recruiting

• Conditions: Healthy

• Registration Number: NCT06728098
• Lead Sponsor: Wecare Probiotics Co., Ltd.

Brief Summary

This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in healthy adult.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-11
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-29
• Study Start: 2025-11-25
• Primary Completion: 2025-12-25
• Study Completion: 2026-03-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in stool quality	30 days	Stool consistency (using the Bristol Stool Scale) from baseline to day 30. The Bristol Stool Scale is a tool to assess gut health by classifying feces into seven categories based on shape and consistency: types 1-2 indicate constipation, 3-4 are normal, and 5-7 suggest diarrhea.

Trial Locations

Locations (1)

Fakultas Kedokteran Universitas Indonesia; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia