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Completed

NCT Number: NCT04462640

Management of Infant Digestive Disorders and Quality of Life

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Management of Infant Digestive Disorders and Quality of Life

Other

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 outcomes

  1. Quality of life in infants with regurgitation and colic

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Keyrus Biopharma

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2020
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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