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Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic

NCT06462651 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-19

No results posted yet for this study

Summary

This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.

Conditions

  • Infantile Colic

Interventions

DIETARY_SUPPLEMENT

L. reuteri

Supplementation with drops containing L. reuteri once daily for 21 consecutive days

DIETARY_SUPPLEMENT

Placebo

Supplementation with identical drops without L. reuteri once daily for 21 consecutive days

Sponsors & Collaborators

  • BioGaia AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-09
Primary Completion
2026-03-15
Completion
2026-03-15

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 NCT06462651 on ClinicalTrials.gov