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The Effect of Probiotics on Symptoms of Infantile Colic

NCT05198700 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-07-03

No results posted yet for this study

Summary

The aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. It is hypothesized that participants given the probiotic formulation will show a significant reduction in daily crying duration compared to participants receiving the placebo.

Conditions

  • Colic

Interventions

DIETARY_SUPPLEMENT

Probiotic Formulation

Participants will be asked to take one sachet daily, containing 1 billion CFU of the probiotic formula. Sachets must be dissolved in warm water or mother's milk before consumption.

DIETARY_SUPPLEMENT

Placebo

Participants will be asked to take one sachet containing the placebo daily. Sachets must be dissolved in warm water or mother's milk before consumption.

Sponsors & Collaborators

  • ProbiSearch SL

    collaborator INDUSTRY

  • Lallemand Health Solutions

    lead INDUSTRY

Principal Investigators

  • Esther Jiménez Quintana, Ph.D. · ProbiSearch SL

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
8 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2023-09-30
Completion
2024-02-29

Countries

  • Spain

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 NCT05198700 on ClinicalTrials.gov