Status:
COMPLETED
BIFI-OBESE: Clinical Trial in Paediatric Obesity
Lead Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
Conditions:
Obesity, Childhood
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
Obesity is a major, public health concern that affects at least 400 million individuals and is associated with severe disorders including diabetes and cancers. Worldwide, the prevalence of overweight ...
Detailed Description
Study design: A single-center pilot open-label randomized control trial. Population: The study will comprise a total of 100 subjects of both sexes, between 6 and 18 years of age, obese, according to t...
Eligibility Criteria
Inclusion
- both sexes
- between 6 and 18 years of age
- obese, according to the IOTF criteria (Cole TJ et al., 2000)
- pubertal stage ≥ 2 according to the Tanner stage (Tanner et al., 1961)
- HOMA-IR \> 2,5 or insulin \> 15 µU/ml
Exclusion
- Adverse reactions to the product or component of the product (allergies…)
- Genetic obesity (Prader Willi syndrome, Down syndrome), Metabolic obesity (Laurence-biedl syndrome…), endocrinological obesity (Cushinch syndrome, hypotiroidism)
- Chronic diseases, hepatic or gastroenterological diseases
- Medical treatment for chronic diseases
- Probiotic or prebiotic therapies and antibiotic treatment
Key Trial Info
Start Date :
November 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03261466
Start Date
November 20 2013
End Date
October 30 2017
Last Update
January 11 2018
Active Locations (1)
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1
AOU Maggiore della Carità - Clinica Pediatrica - Ambulatorio di Auxologia ed Endocrinologia Pediatrica
Novara, Italy, 28100