Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

Completed

• Conditions: Infantile Colic; Functional Gastrointestinal Disorders; Functional Constipation

• Registration Number: NCT04944628
• Lead Sponsor: AB Biotics, SA

Brief 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.

Study Timeline

• Study Start: 2018-08-15
• Primary Completion: 2018-12-05
• Study Completion: 2018-12-05
• Status Verified: 2021-06
• Study First Submitted: 2021-06-14
• Study First Submitted QC: 2021-06-21
• Last Update Submitted: 2021-06-21
• Study First Posted: 2021-06-29
• Last Update Posted: 2021-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in total FGDI severity	Day 1 and day 14	FGDI severity measured as summatory of excessive crying score (5-point Likert scale (0: no symptoms, to 4: extremely severe symptoms) + constipation score (5-point Likert scales (0: no symptoms, to 4: extremely severe symptoms)

Secondary Outcome Measures

Name	Time	Method
Change in excessive crying severity	Day 1 and day 14	Excessive crying score measured using 5-point Likert scales (0: no symptoms, to 4: extremely severe symptoms)
Change in constipation severity	Day 1 and day 14	Constipation score measured using 5-point Likert scales (0: no symptoms, to 4: extremely severe symptoms)
Change in parental anxiety	Day 1 and day 14	Recorded through the validated Generalized Anxiety Disorder (GAD) 7-item scale (GAD-7).
Tolerability and safety	Daily from day 1 to day 14	Any adverse events experienced throughout study period
Parental satisfaction with the product	Day 14	Measured with a 5-point Likert scale (0: very dissatisfied, to 4: very satisfied)

Trial Locations

Locations (1)

Azienda Sanitaria Locale Napoli; 🇮🇹 Naples, Italy