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Probiotics Strains for Infant Colic

NCT05685030 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-01-13

No results posted yet for this study

Summary

Interest in the use of probiotics as a potential treatment to reduce crying in babies with colic has increased lately. Recent studies have reported that the gut microbiota in infants with colic is characterized by lower proportions of Lactobacilli and Bifidobacteria and higher proportions of opportunistic proteobacteria (such as Escherichia coli, Enterobacter aerogenes and Klebsiella spp.) in comparison with the control babies.

Therefore, based on data in the literature, it is understood that there is evidence of the effectiveness of using probiotics, either alone or in the form of a blend, to alleviate the symptoms of infantile colic.

Conditions

  • Colic

Interventions

DIETARY_SUPPLEMENT

Placebo

product vehicle (sunflower oil)

DIETARY_SUPPLEMENT

Limosilactobacillus reuteri CCT 7862

Limosilactobacillus reuteri CCT 7862 - 1 x 10e9 UFC/ day.

DIETARY_SUPPLEMENT

Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863

Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 - 1 x 10e9 UFC/ day

Sponsors & Collaborators

  • Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
17 Days
Max Age
23 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-05
Primary Completion
2023-01-05
Completion
2023-07-30

Countries

  • Brazil

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 NCT05685030 on ClinicalTrials.gov