Observational Prospective Study With Probiotic Supplementation on Infants With FGDI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-15

Study Completion Date

2018-12-05

Brief Summary

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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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Detailed Description

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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.

Conditions

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Functional Gastrointestinal Disorders Infantile Colic Functional Constipation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Probiotic

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

10 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No