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

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

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Maltodextrin

• Study Type: Interventional
• Enrollment (Estimated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vicky Achmad Ginanjar, bachelor; Phone Number: +62 +62 21 7695513, 7515932; Email: vicky.achmad@equilab-int.com
• Study Contact Backup: Name: Natalina Soesilawati, Dr; Phone Number: 0217695513; Email: ec_fkui@yahoo.com

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Recruiting
      • Fakultas Kedokteran Universitas Indonesia
      • Contact: Natalina Soesilawati; Phone Number: 0217695513; Email: ec_fkui@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Live Akk11; 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; The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).
Experimental: Inactivated Akk11; 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; The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).
Placebo Comparator: Placebo; Healthy Subjects Receiving Placebo : Take 1 maltodextrin capsule every day. Store in cool and dry place, without exposure to light.	Dietary supplement: Maltodextrin; The experimental phase of this study had last 30 days and each patient will make 3 visits (d1,d15,d30).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): November 25, 2025
• Primary Completion (Estimated): December 25, 2025
• Study Completion (Estimated): March 25, 2026

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Actual): December 11, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: WK2024017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No