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Completed

NCT Number: NCT04944628

Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

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

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Key information

Conditions

Functional Gastrointestinal Disorders Colic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Functional Constipation Gastrointestinal Diseases Infant, Newborn, Diseases Infantile Colic

Age range

1 month–10 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Sanitaria Locale Napoli

Naples, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

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

Primary outcomes

  1. 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

  1. 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)

  2. 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)

  3. Change in parental anxiety

    Time frame: Day 1 and day 14

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

  4. Tolerability and safety

    Time frame: Daily from day 1 to day 14

    Any adverse events experienced throughout study period

  5. Parental satisfaction with the product

    Time frame: Day 14

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

Sponsors and collaborators

Lead sponsor

AB Biotics, SA

Industry

Registry information

Official study title

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)

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2021
Registry last updated
Jun 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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