NCT07593170Not yet recruitingPhase 2
AKK Study in Improving Obesity and Metabolic Status in Children and Adolescents
A Randomized, Double-blind, Placebo-controlled Study of Akkermansia Muciniphila AKK PROBIO in Improving Obesity and Metabolic Abnormalities in Children and Adolescents Aged 7-18 Years
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
The problem of obesity among children and adolescents is becoming increasingly serious and may affect their health in adulthood. Researches have found that a type of probiotic in the intestinal tract - "Akkermansia muciniphila" (referred to as AKK), may help regulate metabolism and weight. Although it has shown effects in adults, its safety and efficacy in children and adolescents still need further verification. This study aims to evaluate the effects of supplementing Akkermansia Muciniphila AKK PROBIO on weight, metabolic health and intestinal flora of obese children and adolescents aged 7 to 18.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- 6 Jun 2026
- Primary completion date
- 20 Dec 2026
- Lead sponsor
- Central South University
- Diseases
- Obesity
- NCT number
- NCT07593170
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 6 Jun 2026 to the primary completion date, 20 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have used antibiotics, probiotics, prebiotics or synbiotic products within 3 months prior to screening.
- Have a history of systemic use of glucocorticoids or other drugs that may affect weight and metabolism (such as metformin, systemic glucocorticoids, diuretics, etc.) within 1 month prior to screening.
Other illness
- Have a definite endocrine disorder causing obesity (such as Cushing's syndrome, hypothyroidism), a genetic syndrome (such as Prader-Willi syndrome), or other known organic diseases.
- Have a severe primary disease of the liver, kidney, cardiovascular system, respiratory system or hematopoietic system, etc.
- Subjects are allergic to any component of the study product (AKK probiotic capsules or placebo).
- Have a history of severe gastrointestinal diseases, such as inflammatory bowel disease (IBD).
- Other conditions as determined by the researcher to be unsuitable for participation in this study.
Other
- Subjects are participating in other clinical trials.
Who the study is looking for
- Age range: 7 years old to 18 years old (inclusive of boundary values), gender not restricted.
- Primary obesity: According to the WS/T 586-2018 standard issued by the National Health Commission of China, or the internationally recognized CDC/WHO standard, diagnosed as obesity (if BMI ≥ the 95th percentile of children of the same age and gender).
- The subjects and their legal guardians understand the research content, voluntarily participate and sign the written informed consent form (for guardians), and the informed consent form (for children aged 8 years and above).
- Able to comply with the research protocol, complete all visits and sample collection.
Age in the registry: 7 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangya School of Public Health Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.