First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic (BACTECOLIC)
Primary Purpose
Colic
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Bactecal® D Liquid
Sponsored by
About this trial
This is an interventional treatment trial for Colic
Eligibility Criteria
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 %
Sites / Locations
- UZ BrusselRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Open label Bactecal® D Liquid 1 dose
Open label Bactecal® D Liquid 2 doses
Arm Description
Patients will receive 1 dose of Bactecal® D Liquid by day which corresponds to 2 ml of product
Patients will receive 2 doses of Bactecal® D Liquid by day which correspond to 4 ml of product.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change of daily median crying time
By measuring the mean change in crying time
Change of the number of crying
By measuring the numbers per day
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05052476
Brief Title
First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic
Acronym
BACTECOLIC
Official Title
First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
October 8, 2023 (Anticipated)
Study Completion Date
October 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astel Medica
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open label Bactecal® D Liquid 1 dose
Arm Type
Experimental
Arm Description
Patients will receive 1 dose of Bactecal® D Liquid by day which corresponds to 2 ml of product
Arm Title
Open label Bactecal® D Liquid 2 doses
Arm Type
Experimental
Arm Description
Patients will receive 2 doses of Bactecal® D Liquid by day which correspond to 4 ml of product.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bactecal® D Liquid
Intervention Description
The patients will be randomized into two arms, A and B, in function of the intervention dose
Primary Outcome Measure Information:
Title
Change in parent quality of life (QoL) score
Description
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
Secondary Outcome Measure Information:
Title
Change of daily median crying time
Description
By measuring the mean change in crying time
Time Frame
Change from baseline daily median crying time at 28 days
Title
Change of the number of crying
Description
By measuring the numbers per day
Time Frame
Change from baseline number of crying at 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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 %
Facility Information:
Facility Name
UZ Brussel
City
Brussel
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvan Vandenplas, MD
Phone
+32 (0)477 57 94
Email
yvan.vandenplas@uzbrussel.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic
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