Gut microbiota changes after starting Compleat Paediatric Nature Mix in kids on exclusive enteral nutrition

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center observational study evaluating fecal microbiota changes in children aged 1–16 years who require exclusive enteral nutrition and are switched to Compleat Paediatric Nature Mix. Researchers will use shotgun metagenomics to analyze stool samples and will also monitor digestive tolerance, bowel habits, sleep quality, feeding rate, and related medications over six months. The study hypothesizes that fibers in the food-based formula promote beneficial gut bacteria and short-chain fatty acid production, potentially improving digestive tolerance. The work is conducted at a single Nantes pediatric center in collaboration with PhAN laboratory, with inclusion based on routine clinical care and French-language understanding. There is no randomization or control group as the design is observational and non-interventional.

Why it matters

Who can join: the full rules

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

Where it's running

• ESEAN - APF France Handicap
  Nantes, France Recruiting

Study contacts

• Study coordinator: Guy LETELLIER, PH
• Email: guy.letellier@apf.asso.fr
• Phone: +33240343884

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.