Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

AB Biotics, SA36 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Functional Gastrointestinal Disorders Infantile Colic Functional Constipation

Interventions

ProbioticDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 1 MonthMax age: 10 Months

Medical Language ↔ Plain English

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

Locations (1)

Azienda Sanitaria Locale Napoli

Naples, Italy

Outcomes

Primary Outcomes

Change in total FGDI severity

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)

Time frame: Day 1 and day 14

Secondary Outcomes

Change in excessive crying severity

Excessive crying score measured using 5-point Likert scales (0: no symptoms, to 4: extremely severe symptoms)

Time frame: Day 1 and day 14

Change in constipation severity

Constipation score measured using 5-point Likert scales (0: no symptoms, to 4: extremely severe symptoms)

Time frame: Day 1 and day 14

Change in parental anxiety

Recorded through the validated Generalized Anxiety Disorder (GAD) 7-item scale (GAD-7).

Time frame: Day 1 and day 14

Tolerability and safety

Any adverse events experienced throughout study period

Time frame: Daily from day 1 to day 14

Parental satisfaction with the product

Measured with a 5-point Likert scale (0: very dissatisfied, to 4: very satisfied)

Time frame: Day 14

Data from ClinicalTrials.gov

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