NCT04944628

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2018

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
Last Updated

June 29, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

June 14, 2021

Last Update Submit

June 21, 2021

Conditions

Functional Gastrointestinal DisordersInfantile ColicFunctional Constipation

Keywords

FGDIprobiotic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in excessive crying severity

    Day 1 and day 14

  • Change in constipation severity

    Day 1 and day 14

  • Change in parental anxiety

    Day 1 and day 14

  • Tolerability and safety

    Daily from day 1 to day 14

  • Parental satisfaction with the product

    Day 14

Interventions

ProbioticDIETARY_SUPPLEMENT

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

Eligibility Criteria

Age1 Month - 10 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Population selected from primary care clinic.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Sanitaria Locale Napoli

Naples, Italy

Location

Related Publications (3)

  • 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.

    PMID: 16717171BACKGROUND

  • 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.

    PMID: 27144631BACKGROUND

  • 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.

    PMID: 35095783DERIVED

MeSH Terms

Conditions

Gastrointestinal DiseasesColic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Digestive System DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Maura Sticco, MD

    Azienda Sanitaria Locale Napoli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 29, 2021

Study Start

August 15, 2018

Primary Completion

December 5, 2018

Study Completion

December 5, 2018

Last Updated

June 29, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)