Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

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)

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

Study Overview

• Status: Completed
• Conditions: Functional Gastrointestinal Disorders; Infantile Colic; Functional Constipation
• Intervention / Treatment: Dietary supplement: Probiotic

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy
    • Azienda Sanitaria Locale Napoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Population selected from primary care clinic.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AB Biotics, SA
• Investigators: Principal Investigator: Maura Sticco, MD, Azienda Sanitaria Locale Napoli

Publications and helpful links

General Publications

• 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.
• Asto E, Huedo P, Altadill T, Aguilo Garcia M, Sticco M, Perez M, Espadaler-Mazo J. Probiotic Properties of Bifidobacterium longum KABP042 and Pediococcus pentosaceus KABP041 Show Potential to Counteract Functional Gastrointestinal Disorders in an Observational Pilot Trial in Infants. Front Microbiol. 2022 Jan 12;12:741391. doi: 10.3389/fmicb.2021.741391. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): December 5, 2018
• Study Completion (Actual): December 5, 2018

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: probiotic; FGDI
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Infant, Newborn, Diseases; Gastrointestinal Diseases; Digestive System Diseases; Constipation; Colic
• Other Study ID Numbers: Normocolic ADL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No