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NCT Number: NCT07816536

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

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.

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Key information

Conditions

Feeding and Eating Disorders of Childhood Enteral Nutrition Dependence Feeding and Eating Disorders Mental Disorders

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ESEAN - APF France Handicap

Nantes, France

Location status: Recruiting

Location contact

Guy LETELLIER, PH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. Change in bowel habits assessed using the Bristol Stool Scale

    Time frame: 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).

  2. Change in digestive tolerance assessed by the presence of bloating, abdominal distension, flatulence, nausea, regurgitation, and vomiting

    Time frame: 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.

  3. Change in sleep quality assessed by nocturnal awakenings related to digestive symptoms

    Time frame: 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.

  4. Change in enteral feeding rate (mL/hour)

    Time frame: Baseline, Month 1, Month 2, Month 3, and Month 6

  5. Change in the use of laxatives, antidiarrheals, and antiemetics

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guy LETELLIER, PH

CONTACT

[email protected]

+33240343884

Hélène AUBLE, PharmD

CONTACT

[email protected]

+33240343884

Sponsors and collaborators

Lead sponsor

Establishment for Children and Adolescents in the Nantes Region

Other

Registry information

Official study title

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.

Acronym: COMPLEAT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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