ObesityObese AdolescentsObese Children and AdolescentsAkkermansia Muciniphila
Investigational drug(s) / intervention(s)
AKKPlacebo (maltodextrin)
AKK: This intervention trial intends to use pasteurized AKK PROBIO, with each dose containing the equivalent of 30 billion inactivated bacterial cells. AKK PROBIO is a research hotspot in the field of intestinal microecology. The pasteurized AKK PROBIO (belonging to prebiotics) have been proven to have good safety and metabolic improvement effects in adults. Compared to live bacterial preparations, the inactivated form has higher stability, a longer shelf life, and better safety. AKK group (n=50): The subjects take one AKK probiotic capsule orally before each breakfast and dinner every day, and the intervention lasted for 12 weeks. During the study period, both groups of participants will receive unified and standardized health education, which includes the principles of balanced diet provided by registered dietitians and the suggestions for physical activities provided by exercise rehabilitation specialists.
Placebo (maltodextrin): Placebo group (n=50): The subjects took one placebo capsule (containing inert ingredients such as maltodextrin) identical in appearance and taste to the AKK probiotic capsules before each breakfast and dinner every day for 12 consecutive weeks. After the study ended, the subjects in the placebo group could receive the same dose and specification of AKK probiotic capsules.
Study summary
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
Sex
ALL
Min age
7 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
Z - score — During the baseline period (T0), the middle period (T1, 6 weeks), and the end of the intervention (T2, 12weeks) The Z-score for children (Z-score) is a statistical indicator that measures the deviation of children's growth indicators such as height (in meters), weight (in kilograms), and BMI (in kg/m\^2) from the reference population of the same age and gender. It is used to assess nutritional status and growth development levels.
The nutritional status can be judged by evaluating the height-for-age z-score (HAZ), weight-for-age Z-score (WAZ), and weight-for-height z-score (WHZ) of children and BMI-for-age Z-score (BMIZ).
The Z-score formula is: Z = (Measured value - Average value of the reference population) / Standard deviation of the reference population.
Standard： ±2 : Normal range (95% healthy children)
* -2 ≤ Z \< -1: Less than Normal
* Z \< -2： Growth retardation, low weight or emaciation (\<-3 is severe)
* +1 ≤ Z ≤ +2： Overweight
* +2 ≤ Z ≤ +3： Obesity
* Z \> +3： Severe obesity
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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