overweight, obese
Conditions
Interventions
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Overweight/Obese Children 1. Age 6-17 years; 2. Birth gestational age of 37-42 weeks; 3. Diagnostic criteria for overweight/obese children and adolescents: According to the national health industry standard "Screening for Overweight and Obesity in School-aged Children and Adolescents" (WS/T 586-2017) issued by the National Health Commission in 2018, overweight and obesity are defined based on body mass index (BMI) by age. BMI equal to or greater than the 'overweight' threshold but less than the 'obesity' threshold for the corresponding age and sex group is considered overweight. BMI equal to or greater than the 'obesity' threshold for the corresponding age and sex group is considered obese; 4. No infectious diseases or history of antibiotic or probiotic use in the past 4 weeks; 5. The parents or other legal guardians of the volunteer fully understand the trial and voluntarily sign the informed consent form before any research procedures begin. Inclusion Criteria for Healthy Children 1. Age 6-17 years; 2. Birth gestational age of 37-42 weeks; 3. Clinically diagnosed by a physician as a healthy child within the normal weight range; 4. The parents or other legal guardians of the volunteer fully understand the trial and voluntarily sign the informed consent form before any research procedures begin.
Exclusion criteria
Exclusion criteria: 1.Fluctuation in BMI exceeding 10% within the past three months; 2.Use of probiotics within the past four weeks; 3.Presence of gastrointestinal symptoms such as abdominal pain or diarrhea within the past four weeks; 4.Antibiotic treatment within the past four weeks; 5.Significant underlying medical conditions including congenital heart disease, severe asthma, chronic hepatitis, renal insufficiency, neurodegenerative disorders, and major genetic diseases; 6.Individuals with type 1 or type 2 diabetes requiring insulin or hypoglycemic medications, as well as those taking medications affecting appetite, body weight, blood glucose, blood lipids, or anti-inflammatory drugs; 7.Individuals unwilling to continue participation in the study or non-compliant with intervention protocols; 8.Participation in other clinical intervention studies involving pharmaceuticals, dietary supplements, probiotics, or prebiotics within the past three months; 9.Presence of severe infections or major trauma as determined by investigators, or undergoing moderate to major surgery within the past month; 10.Known allergy to any components of the probiotic products; 11.Investigators' judgment that the participant is unsuitable for this clinical study due to other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anthropometric indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Level of gut microbiota;Level of Microbial metabolites;Quality of life scale;Fecal immune indicators;Dietary intake; | — |
Countries
China
Contacts
Public ContactJia Jie
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed