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Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

Functional Gastrointestinal Disorders Clinical Trial

Official title:
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)

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04944628
Study type Observational
Source AB Biotics, SA
Contact
Status Completed
Phase
Start date August 15, 2018
Completion date December 5, 2018
View Details
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