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

Conditions: Feeding and Eating Disorders of Childhood, Enteral Nutrition Dependence

Sex: All

Ages: 1 Year – 16 Years

Healthy volunteers: No

Enrollment: 8

Sponsor: Establishment for Children and Adolescents in the Nantes Region

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 Criteria

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 (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07816536). StuddyBuddy aggregates publicly available trial information.