Actively Recruiting
Safety and Tolerability Evaluation of Akkermansia Muciniphila
Led by Wecare Probiotics Co., Ltd. · Updated on 2025-07-29
108
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of Akkermansia muciniphila Akk11 in healthy adult.
CONDITIONS
Official Title
Safety and Tolerability Evaluation of Akkermansia Muciniphila
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 60 years at screening
- Healthy based on investigator judgment and screening data
- Non-childbearing potential or practicing adequate contraception if of childbearing potential
- No smoking in the past month prior to screening
- Healthy and balanced diet including adequate fiber intake
- Ability to comply with the trial protocol
- Signed informed consent obtained before any trial activities
You will not qualify if you...
- History or presence of diabetes, immunodeficiency disorders, or chronic illness
- Regular use of medications affecting the gastrointestinal system or gut microbiota, including antibiotics and immunosuppressants
- Daily use of probiotics or probiotic-containing products within one month prior to randomization
- Pregnant, planning pregnancy, or breastfeeding (confirmed by urinary pregnancy test at screening)
- Change type of diet during study
- Known allergy or intolerance to any ingredients in the study product
- History of drug, alcohol, or substance abuse or other factors limiting study cooperation
- History or presence of eating disorder
- Condition that makes the subject ineligible according to the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430
Actively Recruiting
Research Team
V
Vicky Achmad Ginanjar, bachelor
CONTACT
N
Natalina Soesilawati, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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