Management of Infant Digestive Disorders and Quality of Life

Nestlé

Status

Completed

Conditions

Gastrointestinal Dysfunction

Infant Nutrition Disorders

Treatments

Other: Management of Infant Digestive Disorders and Quality of Life

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04462640

2019-A03340-57

Details and patient eligibility

About

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.

Full 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

Enrollment

101 patients

Sex

All

Ages

1 week to 4 months old

Volunteers

Accepts Healthy Volunteers

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