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Intervention with Lactobacillus paracase on children with obesity: a randomized double-blind clinical trial

Intervention with Lactobacillus paracase on children with obesity: a randomized double-blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097479
Enrollment
Unknown
Registered
2025-02-19
Start date
2023-07-30
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Obesity

Interventions

LPB intervention group:Lactobacillus paracasei 27 10 billion cfu per day for 12 weeks

Sponsors

The Second Affiliated Hospital of Hangzhou Normal University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) Age 5-18 years old, male or female; (2) BMI= P85 of BMI of children of the same age and sex, that is, BMI Z score=1.04; (3) have not received obesity-related drug therapy or surgical treatment; (4) The subject and guardian are willing and able to cooperate with the scheduled trial procedures such as visits, treatment plans and laboratory examinations, and sign written informed consent.

Exclusion criteria

Exclusion criteria: (1) A history of drug use, including antibiotics and supplements; a. Use of medications or supplements in the past 3 months to control weight or body fat b. Use medications/supplements to control blood sugar c. Medication (drugs/supplements) for high blood pressure or dyslipidemia d. Use of laxatives or fiber supplements in the past 6 weeks e. Use a vitamin D supplement =100 µg/ day f. Use probiotic supplements within the past 6 weeks g. Frequent use of nonsteroidal anti-inflammatory drugs, systemic or inhaled corticosteroids, or systemic immunomodulatory drugs h. Use proton pump inhibitors regularly (more than once a week) i. Recent (past 3 months) or continuous use of antibiotics (2) hereditary obesity (e.g. Prader Willi syndrome); (3) Those who are known to be highly allergic or allergic to probiotic products of this study; (4) Medical history: gastrointestinal disease, chronic active inflammatory disease, cardiovascular disease, liver dysfunction/disease, renal dysfunction/disease, dementia, thyroid disease, pancreatic disease, history of cancer within the past 5 years, or any other disease or condition that the investigator believes may interfere with the study results or the safety of the subjects (5) History of bariatric surgery; (6) Immunosuppression or ongoing treatment resulting in immunosuppression; (7) Atypical celiac disease; (8) other hereditary diseases; (9) Have participated in any other clinical trial within 3 months and have used drug or non-drug intervention; (10) Other conditions deemed unsuitable for inclusion in this clinical study by the investigator.

Design outcomes

Primary

MeasureTime frame
Body Mass Index;Body composition;physique;

Secondary

MeasureTime frame
Fasting blood glucose;Fasting insulin;Glycosylated hemoglobin;Abdominal ultrasound;Blood routine;7 items of blood lipids;Gut Microbiota;Interleukin-6;Interleukin-10;Tumor necrosis factor-a;lipopolysaccharide;High-sensitivity C-reactive protein;25-hydroxy vitamin D ;amino acid metabolism;short chain fatty acids;Liver and kidney function;Routine urine test;

Countries

China

Contacts

Public ContactLi li

Affiliated Hospital of Hangzhou Normal University

lislucy@163.com+86 153 9581 5033

Outcome results

None listed

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