Feeding and Eating Disorders of ChildhoodCOMPLEATNCT07816536
Gut Microbiota Changes in Children Receiving Exclusive Enteral Nutrition With Compleat® Paediatric
An observational study of Feeding and Eating Disorders of Childhood and Enteral Nutrition Dependence, run by Establishment for Children and Adolescents in the Nantes Region at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Feeding and Eating Disorders of Childhood, Enteral Nutrition Dependence
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2026to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children receiving exclusive enteral nutrition via gastrostomy and followed in a pediatric healthcare center.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
ESEAN - APF France Handicap
Nantes
Guy LETELLIER, PH
About this study
Official 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.
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.
Read the 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.
- Keywords
- Gut microbiota, Enteral nutrition, Food-based enteral formula, Digestive tolerance, Gastrostomy feeding, Pediatric nutrition
- Medical subject headings
- Feeding and Eating Disorders of Childhood
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (M0) to Month 2 (M2)
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: Baseline, Month 1, Month 2, Month 3, and Month 6
Change in enteral feeding rate (mL/hour)
Measured: 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.
Measured: Baseline, Month 1, Month 2, Month 3, and Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start4 Mar 2026
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating Disorders of ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Establishment for Children and Adolescents in the Nantes Region
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816536
- Sponsor's protocol ID
- 2025-A00840-49
- Other IDs
- 2025-A00840-49
- Acronym
- COMPLEAT
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07816536
- Acronym / sponsor ID
- COMPLEAT / 2025-A00840-49
- Keywords
- Gut microbiota, Enteral nutrition, Food-based enteral formula, Digestive tolerance, Gastrostomy feeding, Pediatric nutrition
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Establishment for Children and Adolescents in the Nantes RegionUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children receiving exclusive enteral nutrition via gastrostomy and followed in a pediatric healthcare center.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
5 secondary outcomes
Change in bowel habits assessed using the Bristol Stool Scale
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
Time frame: Baseline, Month 1, Month 2, Month 3, and Month 6
Change in sleep quality assessed by nocturnal awakenings related to digestive symptoms
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
Time frame: Baseline, Month 1, Month 2, Month 3, and Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Feeding and Eating Disorders of Childhood and Enteral Nutrition Dependence, run by Establishment for Children and Adolescents in the Nantes Region at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guy LETELLIER, PH (+33240343884, guy.letellier@apf.asso.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.