NCT04462640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

August 28, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2021

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

July 2, 2020

Last Update Submit

August 25, 2022

Conditions

Infant Nutrition DisordersGastrointestinal Dysfunction

Keywords

Quality of lifeInfantsRegurgitationColic

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

regurgitation

45 infants aged 0 to 5 months suffering from regurgitation

Other: Management of Infant Digestive Disorders and Quality of Life

colic

45 infants aged 0 to 5 months suffering from colic

Other: Management of Infant Digestive Disorders and Quality of Life

Interventions

Management of Infant Digestive Disorders and Quality of LifeOTHER

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.

colicregurgitation

Eligibility Criteria

Age1 Week - 4 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

infants between 0 and 5 months

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandra Brancato

Brignon, 30190, France

Location

Related Publications (1)

  • Chouraqui JP, Brancato S, Delmas B, Hanh T. Effectiveness of a starch thickened infant formula with reduced lactose content, probiotics and prebiotics on quality of life and clinical outcome in infants with regurgitation and/or colic. Front Nutr. 2023 May 25;10:1164722. doi: 10.3389/fnut.2023.1164722. eCollection 2023.

    PMID: 37305080DERIVED

MeSH Terms

Conditions

Infant Nutrition DisordersGastroesophageal RefluxColic

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Health StatusDemographyEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 8, 2020

Study Start

August 28, 2020

Primary Completion

November 17, 2021

Study Completion

November 17, 2021

Last Updated

August 26, 2022

Record last verified: 2022-08

Locations

FR(1)