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

NCT05512234 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-09-22

No results posted yet for this study

Summary

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

Conditions

  • Colic, Infantile

Interventions

DIETARY_SUPPLEMENT

L. reuteri

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

DIETARY_SUPPLEMENT

Placebo

Dietary supplementation with placebo drops identical to those containing L. reuteri once daily for 21 consecutive days

Sponsors & Collaborators

  • Atlantia Food Clinical Trials

    collaborator INDUSTRY

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • BioGaia AB

    lead INDUSTRY

Principal Investigators

  • Jenny Palming, PhD · BioGaia AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2025-10-30
Completion
2025-10-30

Countries

  • Ireland
  • Sweden

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 NCT05512234 on ClinicalTrials.gov