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Clinical Trials in France / NCT07816536
Recruiting Observational

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

NCT07816536 · tracked via the Priya Life Science France tracker
Sponsor
Establishment for Children and Adolescents in the Nantes Region
Phase
Observational
Started
2026-03-04
Last updated
2026-09-11

Condition(s) studied

Feeding and Eating Disorders of ChildhoodEnteral Nutrition Dependence

Study summary

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.

Eligibility

Sex
ALL
Min age
1 Year
Max age
16 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in fecal microbiota composition between baseline (M0) and 2 months (M2), assessed by shotgun metagenomic analysis, with a focus on the relative abundance of Bifidobacterium. — Baseline (M0) to Month 2 (M2)

Trial sites (1)

FacilityCityRegionStatus
ESEAN - APF France Handicap Nantes France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07816536 on ClinicalTrials.gov ↗ ← All trials in France