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OpenTrials
Completed

NCT Number: NCT06780007

Weight Loss Effect of Akkermansia Muciniphila in Obese Patients

This study intends to study the effect of Akkermansia muciniphila on weight loss and the improvement of blood inflammation and metabolic indexes in obese patients with low Body Mass Index (BMI) through multi-center clinical studies, and for the first time to innovatively explore the weight loss mechanism of Akkermansia muciniphila by comparing the changes in brain function and fecal microbiota before and after intervention.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, the Air Force Medical University

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

  • 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informed consent is provided prior to entry into study screening, and the patient has understood that the study can be withdrawn at any time from the study without any loss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

  • Pregnant or lactating women, in the reproductive period and not taking contraceptive measures;
  • Oral antibiotics in the past 1 month prior to enrollment;
  • No use of probiotic prebiotic products before 3 weeks of intervention;
  • people without a fitness fat loss program or history of gastric surgery during the intervention period;
  • Patients with severe gastrointestinal diseases;
  • Those who are known to be allergic to synbiotics or similar products;
  • Patients with no self-awareness and those with mental abnormalities;
  • Have a history of organ transplantation or malignant tumor disease;
  • Concurrent use of other experimental drugs or in other clinical trials;
  • Have a history of alcohol, tobacco and other drug abuse;
  • Those who are expected to be unable to complete the magnetic resonance examination;
  • 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.

Treatment and study plan

Probiotic

Dietary Supplement

The trial phase of the study will last 12 weeks and each subject will make 4 follow-up visits (day 0, week 4, week 8 and week 12).

Placebo

Dietary Supplement

The trial phase of the study will last 12 weeks and each subject will make 4 follow-up visits (day 0, week 4, week 8 and week 12).

Primary outcomes

  1. Change in Body Mass Index(BMI)

    Time frame: Day 0, week4, week8, week12.

    BMI = Weight (kg) / [Height (m)]². 24kg/m² ≤ BMI < 28 kg/m² is in the overweight range, and BMI ≥ 28 kg/m² is in the obesity range.

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

Effect of Akkermansia Muciniphila Akk11 on Weight Loss in Obese Patients: a Multicenter, Randomized, Double-blind, Placebo-controlled Study.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.