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First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic

NCT05052476 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-11-28

No results posted yet for this study

Summary

This randomized, open label, dose-response study will be realized at the first line with Bactecal® D Liquid. The objective is to investigate Bactecal® D Liquid in the context of infantile colics.

The patients will be randomized into two arms, A and B, in function of the intervention dose. The quality of life of te parents as well as the daily median crying time and the number of daily crying will be assessed.

Conditions

  • Colic

Interventions

DIETARY_SUPPLEMENT

Bactecal® D Liquid

The patients will be randomized into two arms, A and B, in function of the intervention dose

Sponsors & Collaborators

  • Astel Medica

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-08
Primary Completion
2023-10-08
Completion
2023-10-16

Countries

  • Belgium

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 NCT05052476 on ClinicalTrials.gov