Management of Infant Digestive Disorders and Quality of Life

Sponsor

Nestlé (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04462640

Collaborator

Keyrus Biopharma (Other)

Enrollment

Location

18.9

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infant Nutrition Disorders Gastrointestinal Dysfunction	Other: Management of Infant Digestive Disorders and Quality of Life

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

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Management of Infant Digestive Disorders and Quality of Life

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
regurgitation 45 infants aged 0 to 5 months suffering from regurgitation	Other: Management of Infant Digestive Disorders and Quality of Life 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.
colic 45 infants aged 0 to 5 months suffering from colic	Other: Management of Infant Digestive Disorders and Quality of Life 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.

Arm

Intervention/Treatment

regurgitation

45 infants aged 0 to 5 months suffering from regurgitation

Other: Management of Infant Digestive Disorders and Quality of Life

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.

colic

45 infants aged 0 to 5 months suffering from colic

Other: Management of Infant Digestive Disorders and Quality of Life

Outcome Measures

Primary Outcome Measures

Quality of life in infants with regurgitation and colic [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Week to 4 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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