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NOT YET RECRUITING
NCT07017244
NA

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

Sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino"

View on ClinicalTrials.gov

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

Interventions

DIETARY_SUPPLEMENT

Verum

1st cycle - 30 days continuous use Cycle 2 - 30-day washout

DIETARY_SUPPLEMENT

Active comparator

1st cycle - 30 days continuous use Cycle 2 - 30-day washout

Locations (1)

Gioacchino Calapai

Messina, Italy