NCT04944628

Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

An Observational Prospective Study to Evaluate the Efficacy of 2 Weeks of Oral Supplementation With a Probiotic Formula in Infants With Functional Gastrointestinal Disorders (FGDI)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 36 (actual)
• Sponsor: AB Biotics, SA · Industry
• Sex: All
• Age: 1 Month – 10 Months
• Healthy volunteers: Not accepted

Summary

This observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI)

Detailed description

Functional gastrointestinal disorders (FGDIs) affect one out of two infants during the fist six months of life and do not have an organic cause. Infant colic, so-called excessive crying syndrome, and functional constipation are among the most common paediatric FGDIs. FGDIs pathophysiology is multifactorial and may include phycological factors and alterations of the gut physiology including gut microbiota dysbiosis. Probiotics are proposed as a potential treatment for FGDIs. However, evidence is limited. A probiotic formula composed of strains Bifidobacerium longum CECT 7894 and Pediococcus pentosaceus CECT 8330 is tested in this study.

Conditions

• Functional Gastrointestinal Disorders
• Infantile Colic
• Functional Constipation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Probiotic in liquid format (oil suspension) administered 10 drops once daily for 2 weeks (2x10\^9 cfu/day)

Timeline

• Start date: 2018-08-15
• Primary completion: 2018-12-05
• Completion: 2018-12-05
• First posted: 2021-06-29
• Last updated: 2021-06-29

Locations

1 site across 1 country: Italy