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Management of Infant Digestive Disorders and Quality of Life

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ClinicalTrials.gov Identifier: NCT04462640
Recruitment Status : Not yet recruiting
First Posted : July 8, 2020
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
Keyrus Biopharma
Information provided by (Responsible Party):
Nestlé

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
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

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Management of Infant Digestive Disorders and Quality of Life
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine


Group/Cohort 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.




Primary Outcome Measures :
  1. Quality of life in infants with regurgitation and colic [ Time Frame: 4 months ]
    The main endpoint will be the change in the QUALIN score on D30 compared to inclusion (D0) according to the 2 groups of patients: regurgitation only and colic only.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
infants between 0 and 5 months
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
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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT04462640    
Other Study ID Numbers: 2019-A03340-57
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nestlé:
Quality of life
Infants
Regurgitation
Colic
Additional relevant MeSH terms:
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Digestive System Diseases
Nutrition Disorders
Infant Nutrition Disorders