Effect of POSTbiotics Supplementation on Microbiome in OBese Children: the POST-OB Study

• Status: Recruiting
• Trial end date: 2021-01-07
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the possible effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, on gut microbiota composition and metabolite production. It also wants to determine whether postbiotics supplementation, combined with interventions to improve diet and lifestyle, reduces adverse metabolic consequences together with their co-morbidities.

All participants will follow a behaviour (promotion of physical activity) and dietary treatment according to Italian dietary guidelines for childhood obesity.

Postbiotics and vitamin D3 will be given orally for four months; patients will be evaluated four months after supplementation and diet-lifestyle intervention and four months after the end of supplementation and after the alone diet-lifestyle intervention with blood testing and echosonography of the liver.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Milan
• Treatments: Cholecalciferol; Vitamin D

Criteria

Inclusion Criteria:

• 6- Severe obesity (>3 DS) according to WHO classification.

• Gestational age: 37-42 weeks.

• Birth-weight: > 2500 g e < 4000 g

• Caucasian

Exclusion Criteria:

• secondary obesity

• supplementation with pre/probiotics (in the previous 3 months);

• antibiotic treatment (in the previous 3 months);

• chronic or acute intestinal diseases (in the previous 3 months).