An interventional study of Bactecal® D Liquid in Colic, sponsored by Astel Medica. Completed at 1 site in Belgium. Open to participants aged 2 Weeks to 8 Weeks. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by Astel Medica · Not applicable, Interventional, and Treatment
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.
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's enrollment of 68 is below the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →This is the only study on the registry with Astel Medica as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive 1 dose of Bactecal® D Liquid by day which corresponds to 2 ml of product
Dietary Supplement: Bactecal® D Liquid
Patients will receive 2 doses of Bactecal® D Liquid by day which correspond to 4 ml of product.
Dietary Supplement: Bactecal® D Liquid
The patients will be randomized into two arms, A and B, in function of the intervention dose
Change in parent quality of life (QoL) score
By measuring parent quality of Life (QoL) score. Scale from 1 (minimum) to 7 (maximum). Higher scores mean a better outcome.
Time frame: Change from baseline parent QoL score at 28 days
Change of daily median crying time
By measuring the mean change in crying time
Time frame: Change from baseline daily median crying time at 28 days
Change of the number of crying
By measuring the numbers per day
Time frame: Change from baseline number of crying at 28 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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