Management of Infant Digestive Disorders and Quality of Life

Gastrointestinal Dysfunction Clinical Trial

Official title:

Management of Infant Digestive Disorders and Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04462640
• Other study ID #: 2019-A03340-57
• Status: Completed
• Start date: August 28, 2020
• Est. completion date: November 17, 2021

Study information

• Verified date: August 2022
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: November 17, 2021
• Est. primary completion date: November 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Week to 4 Months

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Dysfunction
• Infant Nutrition Disorders
• Nutrition Disorders

Intervention

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.

Locations

Country	Name	City	State
France	Sandra Brancato	Brignon

Sponsors (2)

Lead Sponsor	Collaborator
Nestlé	Keyrus Biopharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months