Functional Constipation, Functional Gastrointestinal Disorders, Infantile Colic
Conditions
Keywords
FGDI, probiotic
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
Probiotic in liquid format (oil suspension) administered 10 drops once daily for 2 weeks (2x10\^9 cfu/day)
Sponsors
AB Biotics, SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Months to 10 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Italy
Outcome results
None listed