NCT04462640

Management of Infant Digestive Disorders and Quality of Life

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 1 Week – 4 Months
• Healthy volunteers: Accepted

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.

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

Conditions

• Infant Nutrition Disorders
• Gastrointestinal Dysfunction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-08-28
• Primary completion: 2021-11-17
• Completion: 2021-11-17
• First posted: 2020-07-08
• Last updated: 2022-08-26

Locations

1 site across 1 country: France