Observational Prospective Study With Probiotic Supplementation on Infants With FGDI
NCT04944628 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 36
Last updated 2021-06-29
Summary
This observational prospective study evaluates the safety, tolerability and efficacy of a probiotic formula in infants with functional gastrointestinal disorders (FGDI)
Conditions
- Functional Gastrointestinal Disorders
- Infantile Colic
- Functional Constipation
Interventions
- DIETARY_SUPPLEMENT
-
Probiotic
Probiotic in liquid format (oil suspension) administered 10 drops once daily for 2 weeks (2x10\^9 cfu/day)
Sponsors & Collaborators
-
AB Biotics, SA
lead INDUSTRY
Principal Investigators
-
Maura Sticco, MD · Azienda Sanitaria Locale Napoli
Eligibility
- Min Age
- 1 Month
- Max Age
- 10 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-08-15
- Primary Completion
- 2018-12-05
- Completion
- 2018-12-05
Countries
- Italy
Study Locations
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