Inherited Metabolism DiseaseMEALNCT06471842
Study of the Prevalence of Pediatric Eating Disorders in Inherited Metabolic Diseases With Dietary Treatment
An observational study of Inherited Metabolism Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective of this study is to estimate the prevalence of Pediatric Eating Disorders (PED) in Inherited Metabolic Diseases (IMD) with dietary treatment between the age of 12 months and 6 years 11 months. Read more about this study
- Who is it for?
- Ages 12 months to 6 years
- Conditions the study is for
- Inherited Metabolism Disease
- What is being tested?
- MCH (Montreal Children's Hospital) feeding scale questionnaire and parental questionnaire
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 21 Aug 2024to Aug 2026
- 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 12 months to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with Inherited Metabolism Disease (IMD) with dietary treatment planning to come for a hospital visit as part of their standard care.
Who may be able to join
- Patient from 12 months to 6 years and 11 months old
- Patient with an Inherited Metabolic Diseases with dietary treatment
- Patient having experimented a dietary diversification at least 6 month prior
- Patient whose parents do not object to their participation in the study
Who cannot join
- Patient with an associated chronic disease
- Patient with diagnosed Autistic Spectrum Disorder (ASD) or Pervasive Developmental Disorders (PDD)
- Patient born before 36 weeks of amenorrhea
- Patient with multiple disabilities
- Patient with dystonia
- Patient with absent or unstable head posture
- Patient whose parents do not fully understand or speak French
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
Necker Enfants Malades Hospital
Paris, 75015
Manon TESSIER, +33 1 87 89 20 65, manon.tessier@aphp.fr
About this study
The main objective of this study is to estimate the prevalence of Pediatric Eating Disorders (PED) in Inherited Metabolic Diseases (IMD) with dietary treatment between the age of 12 months and 6 years 11 months.
Read the detailed description
Inherited Metabolic Diseases (IMDs) are rare conditions, which are the consequence of a genetic defect affecting an enzyme or a transporter involved in metabolism. This enzymatic defect leads to the accumulation of a potentially toxic compound located upstream of the deficiency and/or the absence of a compound located downstream of the defect. Treatment is possible and it consists of dietary and/or drug treatment.
Pediatric Eating Disorders (PED) cover "all the difficulties of oral feeding. These may be disorders due to absence of spontaneous feeding behavior, or refusal to eat, and disorders which affect the child's entire psychomotor, language and emotional development.
To date, the investigators note the absence of data on the prevalence of PED in IMDs and more generally on the quality of life and psychomotor development of these patients.
The causes and mechanisms of PED are numerous and heterogeneous. Their origins can be endogenous and/or exogenous.
Our main hypothesis is that the presence of PEDs varies depending on the different categories of IMDs with dietary treatment. Estimating their prevalence would enable awareness and early, better quality care.
This study aims to obtain clear and consistent results from a validated scale. It is a single-site study prospectively including patients from the Necker-Enfants Malades hospital reference center.
Parents will be informed of the study by an investigator (psychomotor therapist or dietician) during a phone call, by email or in hospital prior to the inclusion visit.
On the day of inclusion, the parent's and the child's (depending on their age) non-opposition will be collected before carrying out any procedure and recorded in the patient's medical file.
The MCH (Montreal children's hospital) scale and the parental questionnaire will be proposed by the study investigators at the same time, in a physical interview.
The collection of medical data in the patient's file and the rating of the MCH scale will be done in parallel by the study investigators.
- Conditions
- Inherited Metabolism Disease
- Being tested
- MCH (Montreal Children's Hospital) feeding scale questionnaire and parental questionnaire
- Keywords
- Inherited Metabolism Disease, Paediatric eating disorders, Dietary treatment, Montreal feeding scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCH (Montreal Children's Hospital) feeding scale questionnaire and parental questionnaireOther
The patient's parents will answer the questionnaire and the investigator will complete the parental questionnaire while asking the questions.
| Study group | Role | What they receive |
|---|---|---|
| Children with Inherited Metabolism Disease (IMD) with dietary treatment | Children with Inherited Metabolism Disease (IMD) with dietary treatment planning to come for a hospital visit (in or out patient) as part of their standard care. Receives: Other: MCH (Montreal Children's Hospital) feeding scale questionnaire and parental questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding scale score
MCH (Montreal Children's Hospital) feeding scale score between the age of 12 months and 6 years 11 months.
Measured: 1 day
Secondary outcomes (3)
Disorders severity level differentiation
Differentiation between severe/moderate/mild paediatric eating disorders (PED) using the MCH scale score. This scale makes it possible to differentiate the disorders severity level: mild PED with a score between 61 and 65, moderate PED with a score between 66 and 70 and severe PED with a score higher than or equal to 71.
Measured: 1 day
Paediatric eating disorders prevalence for each pathology
Estimate for each pathology the paediatric eating disorders prevalence using the MCH scale score
Measured: 1 day
Risk factors identification
Identify the paediatric eating disorders' risk factors which are inherent to the disease, environmental and psycho-affective based on the parental questionnaire created for this purpose and the data collected
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start21 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inherited Metabolism DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Manon Tessier, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06471842
- Sponsor's protocol ID
- APHP240434
- Other IDs
- 2024-A00172-45
- Acronym
- MEAL
- Status last verified
- Oct 2025
- First submitted
- 18 Jun 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramsay M, Martel C, Porporino M, Zygmuntowicz C. The Montreal Children's Hospital Feeding Scale: A brief bilingual screening tool for identifying feeding problems. Paediatr Child Health. 2011 Mar;16(3):147-e17. doi: 10.1093/pch/16.3.147.
PubMed 22379377Evans S, Alroqaiba N, Daly A, Neville C, Davies P, Macdonald A. Feeding difficulties in children with inherited metabolic disorders: a pilot study. J Hum Nutr Diet. 2012 Jun;25(3):209-16. doi: 10.1111/j.1365-277X.2012.01229.x. Epub 2012 Feb 9.
PubMed 22320889Ouattara A, Resseguier N, Cano A, De Lonlay P, Arnoux JB, Brassier A, Schiff M, Pichard S, Fabre A, Hoebeke C, Guffon N, Fouilhoux A, Broue P, Touati G, Dobbelaere D, Mention K, Labarthe F, Tardieu M, De Parscau L, Feillet F, Bonnemains C, Kuster A, Labrune P, Barth M, Damaj L, Lamireau D, Berbis J, Auquier P, Chabrol B. Individual and Family Determinants for Quality of Life in Parents of Children with Inborn Errors of Metabolism Requiring a Restricted Diet: A Multilevel Analysis Approach. J Pediatr. 2023 Mar;254:39-47.e4. doi: 10.1016/j.jpeds.2022.08.060. Epub 2022 Oct 17.
PubMed 36265570
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence of Pediatric Eating Disorders in Inherited Metabolic Diseases With Dietary Treatment
- ClinicalTrials.gov ID
- NCT06471842
- Acronym / sponsor ID
- MEAL / APHP240434
- Conditions
- Inherited Metabolism Disease
- Keywords
- Inherited Metabolism Disease, Paediatric eating disorders, Dietary treatment, Montreal feeding scale
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 24 Jun 2024 (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.
The main objective of this study is to estimate the prevalence of Pediatric Eating Disorders (PED) in Inherited Metabolic Diseases (IMD) with dietary treatment between the age of 12 months and 6 years 11 months.
Detailed description
Inherited Metabolic Diseases (IMDs) are rare conditions, which are the consequence of a genetic defect affecting an enzyme or a transporter involved in metabolism. This enzymatic defect leads to the accumulation of a potentially toxic compound located upstream of the deficiency and/or the absence of a compound located downstream of the defect. Treatment is possible and it consists of dietary and/or drug treatment.
Pediatric Eating Disorders (PED) cover "all the difficulties of oral feeding. These may be disorders due to absence of spontaneous feeding behavior, or refusal to eat, and disorders which affect the child's entire psychomotor, language and emotional development.
To date, the investigators note the absence of data on the prevalence of PED in IMDs and more generally on the quality of life and psychomotor development of these patients.
The causes and mechanisms of PED are numerous and heterogeneous. Their origins can be endogenous and/or exogenous.
Our main hypothesis is that the presence of PEDs varies depending on the different categories of IMDs with dietary treatment. Estimating their prevalence would enable awareness and early, better quality care.
This study aims to obtain clear and consistent results from a validated scale. It is a single-site study prospectively including patients from the Necker-Enfants Malades hospital reference center.
Parents will be informed of the study by an investigator (psychomotor therapist or dietician) during a phone call, by email or in hospital prior to the inclusion visit.
On the day of inclusion, the parent's and the child's (depending on their age) non-opposition will be collected before carrying out any procedure and recorded in the patient's medical file.
The MCH (Montreal children's hospital) scale and the parental questionnaire will be proposed by the study investigators at the same time, in a physical interview.
The collection of medical data in the patient's file and the rating of the MCH scale will be done in parallel by the study investigators.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Inherited Metabolism Disease (IMD) with dietary treatment | – | Other: MCH (Montreal Children's Hospital) feeding scale questionnaire and parental questionnaireChildren with Inherited Metabolism Disease (IMD) with dietary treatment planning to come for a hospital visit (in or out patient) as part of their standard care. |
Who may qualify
- Ages
- 12 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with Inherited Metabolism Disease (IMD) with dietary treatment planning to come for a hospital visit as part of their standard care.
Key inclusion criteria (4 listed)
- Patient from 12 months to 6 years and 11 months old
- Patient with an Inherited Metabolic Diseases with dietary treatment
- Patient having experimented a dietary diversification at least 6 month prior
- Patient whose parents do not object to their participation in the study
Key exclusion criteria (7 listed)
- Patient with an associated chronic disease
- Patient with diagnosed Autistic Spectrum Disorder (ASD) or Pervasive Developmental Disorders (PDD)
- Patient born before 36 weeks of amenorrhea
- Patient with multiple disabilities
- Patient with dystonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCH (Montreal Children's Hospital) feeding scale questionnaire and parental questionnaireThe patient's parents will answer the questionnaire and the investigator will complete the parental questionnaire while asking the questions. | Other | Children with Inherited Metabolism Disease (IMD) with dietary treatment |
Primary outcome
Feeding scale score
Time frame: 1 day
MCH (Montreal Children's Hospital) feeding scale score between the age of 12 months and 6 years 11 months.
3 secondary outcomes
Disorders severity level differentiation
Time frame: 1 day
Paediatric eating disorders prevalence for each pathology
Time frame: 1 day
Risk factors identification
Time frame: 1 day
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 20 Nov 2025.
- Background: PubMed 22379377Ramsay M, Martel C, Porporino M, Zygmuntowicz C. The Montreal Children's Hospital Feeding Scale: A brief bilingual screening tool for identifying feeding problems. Paediatr Child Health. 2011 Mar;16(3):147-e17. doi: 10.1093/pch/16.3.147.
- Background: PubMed 22320889Evans S, Alroqaiba N, Daly A, Neville C, Davies P, Macdonald A. Feeding difficulties in children with inherited metabolic disorders: a pilot study. J Hum Nutr Diet. 2012 Jun;25(3):209-16. doi: 10.1111/j.1365-277X.2012.01229.x. Epub 2012 Feb 9.
- Background: PubMed 36265570Ouattara A, Resseguier N, Cano A, De Lonlay P, Arnoux JB, Brassier A, Schiff M, Pichard S, Fabre A, Hoebeke C, Guffon N, Fouilhoux A, Broue P, Touati G, Dobbelaere D, Mention K, Labarthe F, Tardieu M, De Parscau L, Feillet F, Bonnemains C, Kuster A, Labrune P, Barth M, Damaj L, Lamireau D, Berbis J, Auquier P, Chabrol B. Individual and Family Determinants for Quality of Life in Parents of Children with Inborn Errors of Metabolism Requiring a Restricted Diet: A Multilevel Analysis Approach. J Pediatr. 2023 Mar;254:39-47.e4. doi: 10.1016/j.jpeds.2022.08.060. Epub 2022 Oct 17.
- This is the website of the G2M health network, which brings together resources and expertise on hereditary metabolic diseases at national levelLink provided by the sponsor.
- information website designed by the Oralité group at the Necker-Enfants Malades hospital about paediatric eating disordersLink provided by the sponsor.
- 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.
Manon Tessier principal investigator
Assistance Publique - Hôpitaux de Paris
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 Inherited Metabolism Disease, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 7 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 20 Nov 2025. 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 Manon Tessier (+33 1 87 89 20 65, manon.tessier@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding scale score (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06471842, which also lists 3 linked publications.
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 20 Nov 2025.