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

NCT04151823 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-07-28

No results posted yet for this study

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.

Conditions

  • Childhood Obesity

Interventions

DRUG

Vitamin D3

2 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN: 2 mL of product will give 1600 UI/die of VIT D3.

DRUG

Immunofos

Postbiotics will be given at the dose of 80 mg/day. immunofos from Lactobacillus paracasei CNCM I-5220).

OTHER

Promotion of physical activity

Promotion of physical activity will be encouraged at t0, t1, t2

OTHER

Healthy food habits promotion

Promotion of healthy food habits will be encouraged at t0, t1, t2

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-07
Primary Completion
2021-01-07
Completion
2021-01-07

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04151823 on ClinicalTrials.gov