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

Observational, Single-center Study Evaluating Changes in the Intestinal Microbiota of Children Exclusively Fed Via Gastrostomy When Switching to the Enteral Nutrition Formula Compleat® Paediatric Nature Mix.

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 requiring exclusive enteral nutrition frequently experience gastrointestinal intolerance, including diarrhea, constipation, flatulence, regurgitation, or vomiting. Recently, increasing interest has focused on blended or "real food"-based enteral diets, which may improve tolerance and digestive comfort.

Compleat® Paediatric Nature Mix is the first pediatric enteral formula available on the French market composed of ingredients close to everyday foods, including rehydrated chicken, vegetables, fruit purée, and fruit juice. It is indicated for children with malnutrition or at risk of malnutrition.

This monocentric, non-interventional pilot study conducted at the Establishment for Children and Adolescents' Health in the Nantes region (ESEAN) aims to objectively evaluate changes in the fecal microbiota associated with the introduction of this formula. Microbiota analyses will be performed in collaboration with the PhAN laboratory (Physiology of Nutritional Adaptations, UMR), using shotgun metagenomics.

The primary hypothesis is that dietary fibers contained in food-based enteral nutrition promote the growth of beneficial intestinal bacteria, leading to increased production of short-chain fatty acids that support enterocyte metabolism and improve digestive tolerance.

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