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)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Gastrointestinal Disorders
- Sponsor
- AB Biotics, SA
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in total FGDI severity
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in total FGDI severity
Time Frame: 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 Outcomes
- Change in excessive crying severity(Day 1 and day 14)
- Change in constipation severity(Day 1 and day 14)
- Change in parental anxiety(Day 1 and day 14)
- Tolerability and safety(Daily from day 1 to day 14)
- Parental satisfaction with the product(Day 14)