Fiber fix for fat kids? new study targets gut bugs to fight obesity
NCT ID NCT07321184
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a special fiber supplement, combined with a healthy Mediterranean diet and lifestyle changes, could improve gut bacteria and metabolic health in children with obesity. 36 children aged 8-14 took part for 8 months. The goal was to see if this approach could help manage obesity and related health problems.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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36 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Nov 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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8 to 14 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Pediatrics, Vittore Buzzi Children's Hospital
Milan, 20154, Italy
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