Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

Last updated: June 21, 2021
Sponsor: AB Biotics, SA
Overall Status: Completed

Phase

N/A

Condition

Colic

Bowel Dysfunction

Constipation

Treatment

N/A

Clinical Study ID

NCT04944628
Normocolic ADL
  • Ages 1-10
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with gastrointestinal symptoms related to FGID including functionalconstipation and/or infant colic diagnosed according to Rome IV criteria for clinicalpurposes.
  • ≥ 37 weeks of gestation at birth.
  • ≥ 2500 g of birth weight.

Exclusion

Exclusion Criteria:

  • Infants with failure to thrive (weight gain <100 grams/week on average from birth).
  • Major medical problems (e. g. immunodeficiencies, developmental problems or geneticabnormalities)
  • Gastrointestinal diseases
  • Administered with antibiotics for 4 weeks or probiotics for 2 weeks before or duringstudy

Study Design

Total Participants: 36
Study Start date:
August 15, 2018
Estimated Completion Date:
December 05, 2018

Study 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.

Connect with a study center

  • Azienda Sanitaria Locale Napoli

    Naples,
    Italy

    Site Not Available

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