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NCT05052476: BACTECOLIC

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

Completed NA Last updated 28 November 2023
What this trial tests

NA trial testing Bactecal® D Liquid in Colic in 68 participants. Completed in 16 October 2023.

Timeline
8 April 2022
Primary endpoint
8 October 2023
16 October 2023

Quick facts

Lead sponsorAstel Medica
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment68
Start date8 April 2022
Primary completion8 October 2023
Estimated completion16 October 2023
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

Astel Medica

Who can join

Adults 2 Weeks to 8 Weeks, any sex, with Colic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A synbiotic mixture for the management of infantile colic: A randomized trial.
    Delcourt H, Huysentruyt K, Vandenplas Y. · · 2024 · cited 1× · PMID 39557731 · DOI 10.1007/s00431-024-05860-5

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