Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

AB Biotics

Status: Completed

Conditions: Functional Constipation; Infantile Colic; Functional Gastrointestinal Disorders

Treatments: Dietary Supplement: Probiotic

Study type: Observational

Funder types: Industry

Identifiers

NCT04944628

Normocolic ADL

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 1 to 10 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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 genetic abnormalities)
• Gastrointestinal diseases
• Administered with antibiotics for 4 weeks or probiotics for 2 weeks before or during study