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Gut Microbiota Changes in Children Receiving Exclusive Enteral Nutrition With Compleat® Paediatric

Recruitingn/aAges 1 Year - 16 YearsAllEstablishment for Children and Adolescents in the…
NCT07816536 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This observational, prospective, single-center study aims to evaluate changes in the fecal microbiota of pediatric patients receiving exclusive enteral nutrition following the introduction of Compleat® Paediatric Nature Mix, an enteral formula made from food-derived ingredients. Secondary objectives include the assessment of digestive tolerance, bowel habits, sleep quality, enteral feeding rate, and related medication use over a six-month follow-up period.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Children aged 1 to 16 years * Exclusive enteral nutrition * Followed as part of routine care at the participating pediatric center * Legal guardians and caregivers able to understand French * Covered by the French social security system or equivalent * Documented non-opposition from legal representatives and, when possible, from the child Exclusion Criteria: * Oral feeding or non-exclusive enteral nutrition * Use of oral nutritional supplements * Requirement for hypercaloric (\>1.2 kcal/mL) or hypocaloric (\<1 kcal/mL) enteral formulas * Acute clinical decompensation within one month prior to inclusion * Acute viral or bacterial gastroenteritis within one month prior to inclusion * Antibiotic or probiotic use within three months prior to inclusion
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What it tests

  • Not listed
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Where

1 site
ESEAN - APF France Handicap
Nantes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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