Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Infantile Colic, Functional Gastrointestinal Disorders, Functional Constipation

Intervention / Treatment
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* Dietary Supplement: Probiotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 10 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Probiotic|Probiotic in liquid format (oil suspension) administered 10 drops once daily for 2 weeks (2x10^9 cfu/day)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Day 1 and day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in excessive crying severity | Excessive crying score measured using 5-point Likert scales (0: no symptoms, to 4: extremely severe symptoms) | 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) | Day 1 and day 14 | 
| Change in parental anxiety | Recorded through the validated Generalized Anxiety Disorder (GAD) 7-item scale (GAD-7). | Day 1 and day 14 | 
| Tolerability and safety | Any adverse events experienced throughout study period | 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) | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FGDI, probiotic