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Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic

NCT03434249 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-01-23

Study results available
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Summary

This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic.

Conditions

  • Infantile Colic
  • Colic, Infantile

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium, BB-12® (Bifidolactis Infant)

DIETARY_SUPPLEMENT

Bifidolactis Infant Placebo

Sponsors & Collaborators

  • SOFAR S.p.A.

    lead INDUSTRY

Principal Investigators

  • Roberto Berni Canani, Prof. · Federico II University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
7 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-11
Primary Completion
2017-11-06
Completion
2017-11-06

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03434249 on ClinicalTrials.gov