Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT06728098

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

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, Indonesia, 10430

Actively Recruiting

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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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Safety and Tolerability Evaluation of Akkermansia Muciniphila | DecenTrialz