Clinical trial NCT04462640: Management of Infant Digestive Disorders and Quality of Life
Official title: Management of Infant Digestive Disorders and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Nutrition Disorders
Gastrointestinal Dysfunction
Keywords: Quality of life
Infants
Regurgitation
Colic
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Keyrus Biopharma
First posted: 2020-07-08
Enrollment: 101
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: infants between 0 and 5 months

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 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

Eligibility criteria: Inclusion Criteria:

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 Criteria:

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

Primary outcomes:
measure: Quality of life in infants with regurgitation and colic
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brignon
country: France
facility: Sandra Brancato
Study officials:
References: