Clinical Trial

Effect of a Dietary Supplement vs Low-dosage Product on Infant Gastrointestinal Discomfort and Colics

Study acronym: DISIC
Not Yet Recruiting
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Record status
This record was last updated June 12, 2025 (before its estimated October 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to verify whether a food supplement is effective in treating infantile colic of infants aged between 21 days and 9 months and the colonization ability of the gut microbiota by measuring faecal relative abundance of the gut microbiota probiotic treatment species. The main outcomes are: - the mean number of crying episodes and the sleep duration - Relative abundance of the gut microbiota probiotic treatment species.
Trial Details
NCT Number NCT07017244
Lead Sponsor Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Conditions Infant Colic, Gut Microbiota
Enrollment 150 participants
Start Date 2025-06-15
Primary Completion 2025-10-15 (estimated)
Study Completion 2025-12-15 (estimated)
Updated on ClinicalTrials.gov 2025-06-12