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

NCT04151823 | Unknown Phase 4

• 1 other identifier: 2015/ST/135-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Childhood obesity; Nutrition; Gut microbiota; Postbiotics

Outcome Measures

Primary Outcomes (2)

• Changes in gut microbiota composition

  Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).

  t0: 0 t1: +4 months t2: +8 months

• Changes in short chain fatty acids production by gut microbiota

  Effect of postbiotics supplementation, combined with interventions aimed at improving diet and lifestyle, will be evaluated. Difference in gut microbiota composition will be evaluated before starting supplementation (t0), at the end of supplementation (t1: +4 months) e after 4 months of dietary dietary-lifestyle intervention without supplementation (t2: +8 months).

  t0: 0 t1: +4 months t2: +8 months

Secondary Outcomes (26)

• Changes in HDL-cholesterol levels

  t0: 0 t1: +4 months t2: +8 months

• Changes in LDL-cholesterol levels

  t0: 0 t1: +4 months t2: +8 months

• Changes in triglycerides levels

  t0: 0 t1: +4 months t2: +8 months

• Changes in systemic arterial blood pressure

  t0: 0 t1: +4 months t2: +8 months

• Changes in body mass index

  t0: 0 t1: +4 months t2: +8 months

Study Arms (1)

Postbiotic &vitamin D3, lifestyle intervention.

EXPERIMENTAL

Postbiotics will be given at the dose of 80 mg/day (2 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN; immunofos from Lactobacillus paracasei CNCM I-5220). 2 mL of product will give 1600 UI/die of VIT D3. Healthy living habits will be encouraged at t0, t1 and t2 visit.

Drug: Vitamin D3; Drug: Immunofos; Other: Promotion of physical activity; Other: Healthy food habits promotion

Interventions

Vitamin D3 DRUG

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.

Postbiotic &vitamin D3, lifestyle intervention.

Immunofos DRUG

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

Postbiotic &vitamin D3, lifestyle intervention.

Promotion of physical activity OTHER

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

Postbiotic &vitamin D3, lifestyle intervention.

Healthy food habits promotion OTHER

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

Postbiotic &vitamin D3, lifestyle intervention.

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \<Age \<14 years
• Severe obesity (\>3 DS) according to WHO classification.
• Gestational age: 37-42 weeks.
• Birth-weight: \> 2500 g e \< 4000 g
• Caucasian

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Milan: lead

Study Sites (1)

Ospedale San Paolo

Milan, 20142, Italy

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Central Study Contacts

Elvira Verduci, PhD

CONTACT

3934771218; elvira.verduci@unimi.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Paediatrician, University of Milan Researcher

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 5, 2019
• Study Start: January 7, 2019
• Primary Completion: January 7, 2021
• Study Completion: January 7, 2021
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)