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Canceled by the investigator. Intervention with Lactobacillus paracase on children with obesity: a randomized double-blind clinical study

Intervention with Lactobacillus paracase on children with obesity: a randomized double-blind clinical study - Probiotics intervention on childhood obesity

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068701
Enrollment
Unknown
Registered
2023-02-27
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Intervention group :Probiotics powder
Control group :Use a probiotic powder placebo

Sponsors

Children’s Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age range from 6 to 18 years old, regardless of gender; 2. BMI>=P85 of BMI in children of the same age and gender, i.e. BMI Z score>=1.04; 3. Have not received any obesity related medication or surgical treatment in the past; 4. The subjects and guardians are willing and able to cooperate in completing the scheduled trial procedures such as visits, treatment plans, and laboratory examinations, and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. A history of useful drugs, including antibiotics and supplements; a. Using medication or supplements to control weight or body fat within the past 3 months b. Using medication/supplements to control blood sugar c. Drug treatment (drugs/supplements) hypertension or Dyslipidemia d. Using laxatives or fiber supplements within the past 6 weeks e. Use>=100 µ G/day of vitamin D supplements f. Using probiotic supplements within the past 6 weeks g. Often use Nonsteroidal anti-inflammatory drug, systemic or inhaled Corticosteroid or systemic immunomodulators h. Regular (at least once a week) use of proton pump inhibitors i. Recently (in the past 3 months) or continuously using antibiotics 2. Hereditary obesity (such as Prader Willi syndrome); 3. Actively or recently (in the past 3 months) participated in a weight loss plan (diet and/or exercise); 4. Individuals with known high allergic constitution or allergies to prebiotics in this study; 5. Disease history: gastrointestinal disease, chronic active inflammatory disease, cardiovascular disease, liver dysfunction/disease, kidney dysfunction/disease, dementia, Thyroid disease, pancreatic disease, cancer history in the past five years or any other disease or condition that the researcher believes may interfere with the research results or the safety of the subject 6. History of Bariatric surgery; 7. Immunosuppression or ongoing treatment leading to immunosuppression; 8. Atypical Coeliac disease; 9. Other Genetic disorder; 10. Those who have participated in any other clinical trial within 3 months and have taken drug or Non-pharmaceutical intervention; 11. Other situations that the researcher deems unsuitable for inclusion in this clinical study.

Design outcomes

Primary

MeasureTime frame
Compliance;Diet and exercise;physique;Fasting blood glucose;Fasting insulin;Liver and kidney function;routine blood test;Routine urine test;Fecal routine;Dual-energy X-ray body fat detection;Body composition;Abdominal ultrasound;

Countries

China

Contacts

Public ContactNi Yan

Children’s Hospital affiliated to Medical College of Zhejiang University

yanni617@outlook.com+86 571 8173 2375

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026