BIFI-OBESE: Clinical Trial in Paediatric Obesity

Plain-language summary

This study examines the effects of probiotic supplements containing Bifidobacterium breve compared with placebo in children and adolescents with obesity. It was designed for boys and girls aged 6-18 who are obese according to defined criteria. The study was conducted in Phase 4 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

Azienda Ospedaliero Universitaria Maggiore della Carita

Intervention

Bifidobacterium breve BR03 and Bifidobacterium breve B632, Placebos

Start date

11/20/2013

Estimated completion

10/30/2017

Countries

Italy

Related genes

Locations

• Novara, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. both sexes
2. between 6 and 18 years of age
3. obese, according to the IOTF criteria (Cole TJ et al., 2000)
4. pubertal stage ≥ 2 according to the Tanner stage (Tanner et al., 1961)
5. HOMA-IR \> 2,5 or insulin \> 15 µU/ml

Exclusion Criteria:

1. Adverse reactions to the product or component of the product (allergies…)
2. Genetic obesity (Prader Willi syndrome, Down syndrome), Metabolic obesity (Laurence-biedl syndrome…), endocrinological obesity (Cushinch syndrome, hypotiroidism)
3. Chronic diseases, hepatic or gastroenterological diseases
4. Medical treatment for chronic diseases
5. Probiotic or prebiotic therapies and antibiotic treatment