An observational study in Feeding and Eating Disorders of Childhood and Enteral Nutrition Dependence, sponsored by Establishment for Children and Adolescents in the Nantes Region. Recruiting at 1 site in France. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Establishment for Children and Adolescents in the Nantes Region · Observational
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.
21 studies on the registry are indexed under Feeding and Eating Disorders of Childhood; 3 are open to participants now.
Browse Feeding and Eating Disorders of Childhood studies →This is the only study on the registry with Establishment for Children and Adolescents in the Nantes Region as lead sponsor.
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Children receiving exclusive enteral nutrition via gastrostomy and followed in a pediatric healthcare center.
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Exclusion Criteria:
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.
Time frame: Baseline (M0) to Month 2 (M2)
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).
Time frame: Baseline, Month 1, Month 2, Month 3, and Month 6
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.
Time frame: Baseline, Month 1, Month 2, Month 3, and Month 6
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.
Time frame: Baseline, Month 1, Month 2, Month 3, and Month 6
Change in enteral feeding rate (mL/hour)
Time frame: Baseline, Month 1, Month 2, Month 3, and Month 6
Change in the use of laxatives, antidiarrheals, and antiemetics
Use of gastrointestinal medications (laxatives, antidiarrheals, and antiemetics) will be assessed as the proportion of participants requiring treatment and changes in medication use over time, based on caregiver reports and medical records.
Time frame: Baseline, Month 1, Month 2, Month 3, and Month 6
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Feb 2027, 11 months after the start.
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