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

Launched by AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO "G. MARTINO" · Jun 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at whether a dietary supplement can help reduce gastrointestinal discomfort and colic in infants aged 21 days to 9 months. Infant colic is when babies cry more than normal, and it can be really distressing for both the baby and the parents. The researchers will be measuring how often the babies cry and how well they sleep, as well as looking at the types of bacteria in their gut, which can affect digestion.

To join the study, babies must be between 0 and 9 months old and have been diagnosed with colic. However, there are some important exclusions, such as infants with certain health conditions or allergies, those taking specific medications, or those involved in other studies. The trial is not yet recruiting participants, so there’s no need to sign up right away. If eligible, parents can expect to see if the supplement helps their baby feel more comfortable and possibly lead to less crying and better sleep.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children Age: 0-9 months Infant colics diagnosed with FLACC (Face, Legs, Activity, Cry, Consolability - preverbal patient pain scale) and G4 Infant Colic Rome IV criteria
• Exclusion Criteria:
• • infants suffering from acute or chronic diseases, such as chronic lung disease; diarrhea underlying specific diseases or developmental disorders confirmed by a pediatrician
• • infants participating in other clinical studies
• • age ≥ 9 months
• • neurological diseases
• • suspected or confirmed food allergy to the ingredients of the products under study
• • gastroesophageal reflux disease
• • use of antibiotics 1-2 weeks before enrolment
• • use of gastric acidity inhibitors at any time before enrolment
• • fever and/or infectious diseases at any time before enrolment
• • current systemic infections
• • history of congenital infections