Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

Overview

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

Full Title of Study: “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)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 5, 2018

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 Supplement: Probiotic
    • Probiotic in liquid format (oil suspension) administered 10 drops once daily for 2 weeks (2×10^9 cfu/day)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Change in excessive crying severity
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: Day 1 and day 14
    • Recorded through the validated Generalized Anxiety Disorder (GAD) 7-item scale (GAD-7).
  • Tolerability and safety
    • Time Frame: Daily from day 1 to day 14
    • Any adverse events experienced throughout study period
  • Parental satisfaction with the product
    • Time Frame: Day 14
    • Measured with a 5-point Likert scale (0: very dissatisfied, to 4: very satisfied)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Month

Maximum Age: 10 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AB Biotics, SA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Maura Sticco, MD, Principal Investigator, Azienda Sanitaria Locale Napoli

References

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15:S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. Online ahead of print.

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