First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic
NCT ID: NCT05052476
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
68 participants
INTERVENTIONAL
2022-04-08
2023-10-16
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Open label Bactecal® D Liquid 1 dose
Patients will receive 1 dose of Bactecal® D Liquid by day which corresponds to 2 ml of product
Bactecal® D Liquid
The patients will be randomized into two arms, A and B, in function of the intervention dose
Open label Bactecal® D Liquid 2 doses
Patients will receive 2 doses of Bactecal® D Liquid by day which correspond to 4 ml of product.
Bactecal® D Liquid
The patients will be randomized into two arms, A and B, in function of the intervention dose
Interventions
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Bactecal® D Liquid
The patients will be randomized into two arms, A and B, in function of the intervention dose
Eligibility Criteria
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Inclusion Criteria
* Birth weight \>2750 g
* Aged between 2 and 8 weeks
* Presenting symptoms of infant colic as defined by Rome IV criteria by Zeevenhoven et al. 2017
* Signed written informed consent of the parent/tutor
Exclusion Criteria
* Using probiotics as a treatment, different from the one that could contain the formula at the time of study recruitment
* Acute or chronic illness as judged by the investigator which avoids the participation to the study .
* Parents unable to understand the requirements of study participation as judged by the investigator
* Malnutrition as judged by a body weight/height ratio \<5 %
2 Weeks
8 Weeks
ALL
No
Sponsors
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Astel Medica
INDUSTRY
Responsible Party
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Locations
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UZ Brussel
Brussels, , Belgium
Countries
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Other Identifiers
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BACTECOLIC
Identifier Type: -
Identifier Source: org_study_id