Enteral Nutrition Dependence, Feeding and Eating Disorders of Childhood
Conditions
Keywords
Gut microbiota, Enteral nutrition, Food-based enteral formula, Digestive tolerance, Gastrostomy feeding, Pediatric nutrition
Brief 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.
Detailed description
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.
Interventions
None listed
Sponsors
Establishment for Children and Adolescents in the Nantes Region
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in bowel habits assessed using the Bristol Stool Scale | Baseline, Month 1, Month 2, Month 3, and Month 6 | 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 | Baseline, Month 1, Month 2, Month 3, and Month 6 | 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 | Baseline, Month 1, Month 2, Month 3, and Month 6 | 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) | Baseline, Month 1, Month 2, Month 3, and Month 6 | — |
| Change in the use of laxatives, antidiarrheals, and antiemetics | Baseline, Month 1, Month 2, Month 3, and Month 6 | 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. |
Countries
France
Contacts
CONTACTGuy LETELLIER, PH
CONTACTHélène AUBLE, PharmD
Outcome results
None listed