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Effect of a Dietary Supplement vs Low-dosage Product on Infant Gastrointestinal Discomfort and Colics
Sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
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.
Official title: Randomized Double-blind Monocentric Clinical Trial on the Effect of a Dietary Supplement vs Low-dosage Product on Reduction of Infant Gastrointestinal Discomfort and Colics
Key Details
Gender
All
Age Range
0 Months - 9 Months
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-06-15
Completion Date
2025-12-15
Last Updated
2025-06-12
Healthy Volunteers
No
Conditions
Interventions
Verum
1st cycle - 30 days continuous use Cycle 2 - 30-day washout
Active comparator
1st cycle - 30 days continuous use Cycle 2 - 30-day washout
Locations (1)
Gioacchino Calapai
Messina, Italy