Could a gut bacteria pill help you lose weight? new trial investigates
NCT ID NCT07331974
First seen Jun 25, 2026 · Last updated Jun 30, 2026 · Updated 3 times
Summary
This study tests whether a daily supplement of Akkermansia muciniphila (AKM Lab-01), a type of gut bacteria, can help overweight or obese adults lose weight safely. Two hundred participants will take either the supplement or a placebo for 3 months. Researchers will measure changes in body weight, BMI, blood sugar, and cholesterol to see if the bacteria improve metabolic health.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Akkermansia muciniphila AKM Lab-01 (a gut bacteria supplement)
- What this could lead to
- If it works, this could point toward a new, natural supplement to help with weight loss and improve metabolic health.
- What could go wrong
- This is an early, small trial with only 200 people over 3 months. The supplement may not cause significant weight loss, and results may not apply to everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\) Age: 18-60 years old (inclusive); Gender: male or female. * 2\) Body Mass Index (24.0≤BMI≤40.0 kg/m²). * 3\) Has no taken any medications for metabolic control (e.g., for body weight, blood lipids, or blood glucose) within the past month. * 4\) Has been attempting to manage weight primarily through lifestyle interventions (diet and exercise) for at least one month prior to screening. * 5\) Processes adequate communication and cognitive abilities, is expected to be compliant with long-term medication, and has understood the nature, significance, potential benefits, inconveniences, and risks of the study prior to enrollment. * 6\) For participants of childbearing potential (male or female): Must agree to use at least one medically approved form of contraception (e.g., intrauterine device \[IUD\], oral contraceptives, or condoms) throughout the trial. For female participants of childbearing potential: Must have a negative serum pregnancy test at screening and must be non-lactating. * 7\) Voluntarily agrees to participate by signing the inform consent form and commits to follow the trial treatment plan and visit schedule. Exclusion Criteria: * 1\) A clear history of neurological or psychiatric disorders (including epilepsy and dementia). * 2\) Hyperlipidemia due to secondary causes, such as nephrotic syndrome, hepatic diseases, hypothyroidism, or renal failure. * 3\) Concurrent severe medical conditions deemed by the investigator to require immediate treatment, such as severe diabetes mellitus, hypertriglyceridemia, or cerebrovascular disease. * 4\) Concurrent severe primary diseases of the liver, kidney, or hematopoietic system; or individuals with mental illness. * 5\) Participants with a family history of genetically inherited metabolic disorders. * 6\) Participants currently taking hepatotropic medications. * 7\) Participants with a history of prior bariatric surgery. * 8\) Presence of poorly controlled or unstable acute/chronic diseases, including but not limited to: * Cardiovascular diseases: Unstable angina, myocardial infarction within the past 6 months, symptomatic congestive heart failure (NYHA Class Ⅱ or higher), severe arrhythmia, ect. * Uncontrolled active infectious diseases, malignancies, ect. * 9\) Participants with hepatic or renal insufficiency, defined as: * Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \> 2.5 × ULN (Upper Limit of Normal); * Serum total bilirubin \> 2.5 × ULN; * Creatinine (Cr) \> 1.5 × ULN. * 10\) Urine amylase ≥ 1.5 × ULN, or any other laboratory abnormality deemed by the investigator to be clinically significant and incompatible with study participation. * 11\) History of acute diabetic complications (e.g., diabetic ketoacidosis or hyperosmolar hyperglycemic state) within the past 3 months. * 12\) History of gastrointestinal surgery within the past year, or the presence of severe, active gastrointestinal disease that is not stabilized and may affect drug absorption, distribution, metabolism, or excretion. * 13\) Know hypersensitivity or allergy to any active ingredient or excipient of the investigational product. * 14\) Use of antibiotic therapy or intake of probiotics/prebiotic supplements within 3 month prior to screening. * 15\) Excessive alcohol consumption (defined as \> 30 grams per day for men or \> 20 gram, sraems) with the past 10 years. * 16\) pregnant or lactating women. * 17\) Any other medical condition that, in the judgement of the investigator, may put the participant at increased or be aggravated by participation in the study. The specific reason for exclusion based on this criterion must be documented.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Guangzhou Huangpu District People's Hospital
RECRUITINGGuangzhou, Guangdong, China
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