Status:
COMPLETED
Management of Infant Digestive Disorders and Quality of Life
Lead Sponsor:
Société des Produits Nestlé (SPN)
Collaborating Sponsors:
Keyrus Biopharma
Conditions:
Infant Nutrition Disorders
Gastrointestinal Dysfunction
Eligibility:
All Genders
1-4 years
Brief 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.
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 mana...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
August 28 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 17 2021
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04462640
Start Date
August 28 2020
End Date
November 17 2021
Last Update
August 26 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sandra Brancato
Brignon, France, 30190