Clinical trial NCT04944628: Observational Prospective Study With Probiotic Supplementation on Infants With FGDI
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Gastrointestinal Disorders
Infantile Colic
Functional Constipation
Keywords: FGDI
probiotic
Lead sponsor: AB Biotics, SA
Sponsor class: INDUSTRY
First posted: 2021-06-29
Enrollment: 36
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population selected from primary care clinic.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in total FGDI severity
timeFrame: Day 1 and day 14
Secondary outcomes:
measure: Change in excessive crying severity
timeFrame: Day 1 and day 14
measure: Change in constipation severity
timeFrame: Day 1 and day 14
measure: Change in parental anxiety
timeFrame: Day 1 and day 14
measure: Tolerability and safety
timeFrame: Daily from day 1 to day 14
measure: Parental satisfaction with the product
timeFrame: Day 14
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Azienda Sanitaria Locale Napoli
Study officials:
affiliation: Azienda Sanitaria Locale Napoli
name: Maura Sticco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.