Safety and Tolerability Evaluation of Akkermansia Muciniphila

NCT06728098 | Recruiting

• 1 other identifier: WK2024017
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Changes in stool quality

  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.

  30 days

Study Arms (3)

Live Akk11

EXPERIMENTAL

Healthy Subjects Receiving Probiotic live Akk11: One probiotic Akkermansia muciniphila Akk11 capsule daily (30 billion AFU/capsule). Store in cool and dry place, without exposure to light.

Dietary Supplement: Probiotic

Inactivated Akk11

EXPERIMENTAL

Healthy Subjects Receiving Probiotic Inactivated Akk11: One probiotic Akkermansia muciniphila Akk11 capsule daily (30 billion TFU/capsule). Store in cool and dry place, without exposure to light.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Healthy Subjects Receiving Placebo : Take 1 maltodextrin capsule every day. Store in cool and dry place, without exposure to light.

Dietary Supplement: Maltodextrin

Interventions

Probiotic DIETARY_SUPPLEMENT

The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).

Inactivated Akk11; Live Akk11

Maltodextrin DIETARY_SUPPLEMENT

The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Fakultas Kedokteran Universitas Indonesia

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

MeSH Terms

Interventions

Probiotics; maltodextrin

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Vicky Achmad Ginanjar, bachelor

CONTACT

+62 21 7695513, 7515932; vicky.achmad@equilab-int.com

Natalina Soesilawati, Dr

CONTACT

0217695513; ec_fkui@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 11, 2024
• Study Start: November 25, 2025
• Primary Completion: December 25, 2025
• Study Completion: March 25, 2026
• Last Updated: July 29, 2025

Record last verified: 2024-10

Locations

ID (1)