Infant Nutrition DisordersNCT04462640
Management of Infant Digestive Disorders and Quality of Life
An observational study of Infant Nutrition Disorders and Gastrointestinal Dysfunction, run by Société des Produits Nestlé (SPN) at 1 site in France.
Trial summary
The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic. Read more about this study
- Who is it for?
- Ages 1 week to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition Disorders, Gastrointestinal Dysfunction
- What is being tested?
- Management of Infant Digestive Disorders and Quality of Life
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2020to 17 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 week to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: infants between 0 and 5 months
Who may be able to join
- Full-term infants (> 37 weeks gestation and <42 weeks gestation), less than 4 months of age at recruitment
- Infants with regurgitation and / or colic defined according to Rome IV criteria
- Non-breastfed infants
- Parents who understand and speak French fluently
- Parents agreeing to send their email address and having a computer tool (computer, tablet or smartphone) allowing them to complete the QoL questionnaires and the satisfaction questionnaire
- Parents having understood the protocol and the information given and having given the participation agreement including their acceptance to return for consultation with the same doctor after a period of 30 days.
Who cannot join
- Infant born prematurely (<37 weeks)
- Intercurrent pathology other than a functional intestinal disorder which can by themselves cause, directly or as a result of treatments, a functional intestinal disorder: Study Management of infant digestive disorders and Quality of life
- Food allergy
- Digestive pathology (Gastroenteritis, celiac disease, high or low digestive malformations….)
- Heart failure, cyanogenic heart disease
- Chronic respiratory diseases (bronchopulmonary dysplasia, malformations, respiratory failure)
Show all 16Show fewer
- Neurological pathologies (Cerebral palsy, intracranial hypertension, convulsive state)
- Congenital metabolic pathologies
- Genetic diseases
- Kidney malformations, Vesicoureteral reflux, Kidney failure.
- Drug treatment in progress and which will be continued during the study, other than vitamins (D, K, ...)
- Partial or total breastfeeding
- Infants already fed:
- with a hypoallergenic formula (HA)
- or with a high hydrolyzate of cow's milk proteins or formula based on rice protein hydrolyzate
- Growth retardation (weight and or height less than or equal to - 2 DS) or break in the weight curve (no weight gain or weight loss in the past month) Prescription of drugs or food supplements other than vitamins at the end of the visit
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.
Read the detailed description
The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic, following nutritional management of these disorders by a preparation for thickened infants, reduced in lactose content and supplemented with Lactobacillus reuteri DSM 17938. Quality of life is assessed using the QUALIN questionnaire
- Being tested
- Management of Infant Digestive Disorders and Quality of Life
- Keywords
- Quality of life, Infants, Regurgitation, Colic
- Medical subject headings
- Infant Nutrition Disorders, Gastroesophageal Reflux, Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management of Infant Digestive Disorders and Quality of LifeOther
The variation of the QUALIN score on D30 compared to inclusion (D0) will be described and compared using a Student test for paired data in the case of a normal distribution or a test of the ranks signed by Wilcoxon otherwise.
| Study group | Role | What they receive |
|---|---|---|
| regurgitation | 45 infants aged 0 to 5 months suffering from regurgitation Receives: Other: Management of Infant Digestive Disorders and Quality of Life | |
| colic | 45 infants aged 0 to 5 months suffering from colic Receives: Other: Management of Infant Digestive Disorders and Quality of Life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life in infants with regurgitation and colic
The main endpoint will be an increase in the QUALIN (QUALIté de vie du Nourrison) score on D30 compared to inclusion (D0) according to the 2 groups of patients: regurgitation only and colic only. This score is between -68 to +68. An increase in score means an improvement in symptoms.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start28 Aug 2020
- Primary completion17 Nov 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant Nutrition DisordersStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Keyrus Biopharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462640
- Sponsor's protocol ID
- 2019-A03340-57
- Status last verified
- Aug 2022
- First submitted
- 2 Jul 2020
- Last updated
- 26 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chouraqui JP, Brancato S, Delmas B, Hanh T. Effectiveness of a starch thickened infant formula with reduced lactose content, probiotics and prebiotics on quality of life and clinical outcome in infants with regurgitation and/or colic. Front Nutr. 2023 May 25;10:1164722. doi: 10.3389/fnut.2023.1164722. eCollection 2023.
PubMed 37305080
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Infant Digestive Disorders and Quality of Life
- ClinicalTrials.gov ID
- NCT04462640
- Acronym / sponsor ID
- 2019-A03340-57
- Keywords
- Quality of life, Infants, Regurgitation, Colic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Keyrus Biopharma
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 8 Jul 2020 (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 objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.
Detailed description
The objective of the study is to measure the evolution of the quality of life in infants between 0 and 5 months old, not breastfed and suffering from regurgitation or colic, following nutritional management of these disorders by a preparation for thickened infants, reduced in lactose content and supplemented with Lactobacillus reuteri DSM 17938. Quality of life is assessed using the QUALIN questionnaire
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regurgitation | – | Other: Management of Infant Digestive Disorders and Quality of Life45 infants aged 0 to 5 months suffering from regurgitation |
| colic | – | Other: Management of Infant Digestive Disorders and Quality of Life45 infants aged 0 to 5 months suffering from colic |
Who may qualify
- Ages
- 1 week to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infants between 0 and 5 months
Key inclusion criteria (6 listed)
- Full-term infants (> 37 weeks gestation and <42 weeks gestation), less than 4 months of age at recruitment
- Infants with regurgitation and / or colic defined according to Rome IV criteria
- Non-breastfed infants
- Parents who understand and speak French fluently
- Parents agreeing to send their email address and having a computer tool (computer, tablet or smartphone) allowing them to complete the QoL questionnaires and the satisfaction questionnaire
Key exclusion criteria (16 listed)
- Infant born prematurely (<37 weeks)
- Intercurrent pathology other than a functional intestinal disorder which can by themselves cause, directly or as a result of treatments, a functional intestinal disorder: Study Management of infant digestive disorders and Quality of life
- Food allergy
- Digestive pathology (Gastroenteritis, celiac disease, high or low digestive malformations….)
- Heart failure, cyanogenic heart disease
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 |
|---|---|---|
| Management of Infant Digestive Disorders and Quality of LifeThe variation of the QUALIN score on D30 compared to inclusion (D0) will be described and compared using a Student test for paired data in the case of a normal distribution or a test of the ranks signed by Wilcoxon otherwise. | Other | colic, regurgitation |
Primary outcome
Quality of life in infants with regurgitation and colic
Time frame: 4 months
The main endpoint will be an increase in the QUALIN (QUALIté de vie du Nourrison) score on D30 compared to inclusion (D0) according to the 2 groups of patients: regurgitation only and colic only. This score is between -68 to +68. An increase in score means an improvement in symptoms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Derived from this study: PubMed 37305080Chouraqui JP, Brancato S, Delmas B, Hanh T. Effectiveness of a starch thickened infant formula with reduced lactose content, probiotics and prebiotics on quality of life and clinical outcome in infants with regurgitation and/or colic. Front Nutr. 2023 May 25;10:1164722. doi: 10.3389/fnut.2023.1164722. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Infant Nutrition Disorders and Gastrointestinal Dysfunction, run by Société des Produits Nestlé (SPN) 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 16 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: finished, as of the sponsor's last update on 26 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life in infants with regurgitation and colic (time frame: 4 months). 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 NCT04462640, which also lists 1 linked publication.
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 26 Aug 2022.