Completed

Akkermansia Muciniphila for Weight Loss in Obese Patients

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What is being tested

Probiotic

+ Placebo

Dietary Supplement
Who is being recruted

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorWecare Probiotics Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 21, 2025

Actual date on which the first participant was enrolled.

This clinical trial explores the potential benefits of Akkermansia muciniphila, a type of gut bacteria, in aiding weight loss for obese individuals who have a lower Body Mass Index (BMI). The study aims to understand how this bacteria might assist in reducing weight and improving related health markers, such as inflammation and metabolism. By focusing on obese patients, the study seeks to uncover new methods to tackle obesity, a condition that affects many people and often leads to other health issues. Understanding the role of this bacteria could lead to innovative weight loss strategies. Participants will receive Akkermansia muciniphila to observe its effects on their weight and health markers. The study involves monitoring changes in brain function and gut bacteria composition before and after the treatment. This approach helps measure the bacteria's impact on weight loss and overall health. There are no specific risks mentioned, but the study will provide valuable insights into the possible benefits of using Akkermansia muciniphila for weight management.

Official TitleEffect of Akkermansia Muciniphila Akk11 on Weight Loss in Obese Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Study.
NCT06780007
Principal SponsorWecare Probiotics Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

106 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

Inclusion Criteria: \- 1\) Age 18-65 years old; 2)28≤BMI≤35Kg/m2; 3) Willing and able to comply with the protocol during the study period, and be able to cooperate with the completion of various examinations during the trial. Written informed consent is provided prior to entry into study screening, and the patient has understood that the study can be withdrawn at any time from the study without any loss Exclusion Criteria: 1. Pregnant or lactating women, in the reproductive period and not taking contraceptive measures; 2. Oral antibiotics in the past 1 month prior to enrollment; 3. No use of probiotic prebiotic products before 3 weeks of intervention; 4. people without a fitness fat loss program or history of gastric surgery during the intervention period; 5. Patients with severe gastrointestinal diseases; 6. Those who are known to be allergic to synbiotics or similar products; 7. Patients with no self-awareness and those with mental abnormalities; 8. Have a history of organ transplantation or malignant tumor disease; 9. Concurrent use of other experimental drugs or in other clinical trials; 10. Have a history of alcohol, tobacco and other drug abuse; 11. Those who are expected to be unable to complete the magnetic resonance examination; 12. Combined with serious medical diseases or conditions: such as clinically serious (i.e., active) cardiac disease, severe, uncontrolled medical diseases and infections, severe uncontrollable digestive disorders, severe electrolyte disorders, active disseminated intravascular coagulation, major organ failure, such as decompensated heart, pulmonary, hepatic, renal failure, peripheral neuropathy symptoms, etc.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
10B AFU/four capsules/day Akk11, before meals; Storage: store in a cool, dry place without sun exposure.

Group II

Placebo
Four maltodextrin capsules/day, before meals; Storage: store in a cool, dry place without sun exposure.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The First Affiliated Hospital, the Air Force Medical University

Xi'an, ChinaOpen The First Affiliated Hospital, the Air Force Medical University in Google Maps
CompletedOne Study Center