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.
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
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
Children receiving exclusive enteral nutrition via gastrostomy and followed in a pediatric healthcare center.
Cohort
Prospective
Not listed
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.
Change in bowel habits assessed using the Bristol Stool Scale
Bowel habits will be assessed using the Bristol Stool Form Scale, a 7-point scale ranging fromType 1 (hard lumps, severe constipation) to Type 7 (watery stool, severe diarrhea).
Change in digestive tolerance assessed by the presence of bloating, abdominal distension, flatulence, nausea, regurgitation, and vomiting
Digestive tolerance will be assessed by the presence or absence and frequency of gastrointestinal symptoms, including bloating, abdominal distension, flatulence, nausea, regurgitation, and vomiting, recorded daily by caregivers in a clinical diary and analysed by symptomes decrease, stabilization or increase relative to the baseline state.
Change in sleep quality assessed by nocturnal awakenings related to digestive symptoms
Sleep quality will be assessed by the incidence of nocturnal awakenings per night attributable to digestive symptoms, as reported daily by caregivers in a dedicated clinical diary.
Change in enteral feeding rate (mL/hour)
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