AKK Study in Improving Obesity and Metabolic Status in Children and Adolescents
Starting soon · Phase 2 · Has a placebo group
Conditions studied: Obesity, Obese Adolescents, Obese Children and Adolescents, Akkermansia Muciniphila
In brief
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.
Key facts
- Study ID
- NCT07593170
- Run by
- Central South University
- People needed
- 100
- Starts
- 2026-06-06
- Expected to finish
- 2027-02-12
- Last updated by the study team
- 2026-06-03
Who can join
Age: 7 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- 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.
- Subjects are allergic to any component of the study product (AKK probiotic capsules or placebo).
- Subjects are participating in other clinical trials.
- 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.
Where it is running
- Xiangya School of Public Health — Changsha, Hunan, China
Full record on ClinicalTrials.gov
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