Akkermansia Muciniphila for Weight Loss in Obese Patients
Probiotic
+ Placebo
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.106 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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informed consent is provided prior to entry into study screening, and the patient has understood that the study can be withdrawn at any time from the study without any loss Exclusion Criteria: 1.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.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy 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
The First Affiliated Hospital, the Air Force Medical University
Xi'an, ChinaOpen The First Affiliated Hospital, the Air Force Medical University in Google Maps