AKK Study in Improving Obesity and Metabolic Status in Children and Adolescents
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age7-18
SponsorCentral South University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AKK
- Placebo (maltodextrin)
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Central South University
Lead sponsor
Hunan Children's Hospital
Collaborator
Source ClinicalTrials.gov