Effect of Polysaccharide-based Complex Administration on the Gut Microbiome and Cardio-Metabolic Profile in Children With Obesity and Metabolic Syndrome.

Plain-language summary

This study examined the effect of a polysaccharide-based complex on the gut microbiome and cardio-metabolic profile in children with obesity and metabolic syndrome. It included children aged 8 to 14 who were obese by WHO criteria and metabolically unhealthy; those who had used antibiotics or pre/probiotics in the previous 3 months were not included. It was carried out 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

University of Milan

Intervention

Polysaccharide-based complex

Start date

2/1/2022

Estimated completion

11/30/2024

Countries

Italy

Related genes

Locations

• Milan, Italy

Eligibility criteria

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

Inclusion Criteria:

* age 8 to 14 years;
* obesity defined as BMI z-score ≥+2 standard deviation scores (SDS) based on the WHO growth charts
* gestational age 37-42 weeks;
* birth weight \>2500 g and \<4000 g;
* established condition of MUO, defined as follows:

  1. for children ≤10 years according to the IDEFICS criteria \[waist circumference (WC) ≥90th percentile and ≥1 of the followings triglycerides (TG) ≥90th percentile, HDL cholesterol (HDL) ≤10th percentile, systolic blood pressure (SBP) or diastolic blood pressure (DBP) ≥90th percentile, HOMA-insulin resistance ≥90th percentile or fasting glucose ≥90th percentile\];
  2. for children \>10 years according to the IDF criteria \[WC ≥ 90th percentile and ≥1 of the followings TG ≥ 150 mg/Dl, HDL ≤ 40 mg/dL, SBP ≥ 130 mmHg, DBP ≥ 85 mmHg and fasting blood glucose ≥ 100 mg/dl or known Type 2 Diabetes\]

Exclusion Criteria:

* diagnosis of secondary obesity;
* treatment with pre/probiotics in the previous 3 months;
* antibiotic treatment in the previous 3 months;
* presence of chronic or acute intestinal disease in the previous 3 months