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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colic

Intervention / Treatment
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* Dietary Supplement: Bactecal® D Liquid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full term healthy infant (37-41 weeks amenorrhea) 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: Premature birth 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 %

Ages Eligible for Study
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Minimum Age: 2 Weeks
Maximum Age: 8 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open label Bactecal® D Liquid 1 dose<br>Patients will receive 1 dose of Bactecal® D Liquid by day which corresponds to 2 ml of product | Dietary Supplement: Bactecal® D Liquid<br>* The patients will be randomized into two arms, A and B, in function of the intervention dose<br>|
| Experimental: Open label Bactecal® D Liquid 2 doses<br>Patients will receive 2 doses of Bactecal® D Liquid by day which correspond to 4 ml of product. | Dietary Supplement: Bactecal® D Liquid<br>* The patients will be randomized into two arms, A and B, in function of the intervention dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline parent QoL score at 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of daily median crying time | By measuring the mean change in crying time | Change from baseline daily median crying time at 28 days | 
| Change of the number of crying | By measuring the numbers per day | Change from baseline number of crying at 28 days |