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

Colic Clinical Trial

— BACTECOLIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05052476
• Other study ID #: BACTECOLIC
• Status: Completed
• Phase: N/A
• Start date: April 8, 2022
• Est. completion date: October 16, 2023

Study information

• Verified date: July 2023
• Source: Astel Medica
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 16, 2023
• Est. primary completion date: October 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Weeks to 8 Weeks

Eligibility

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 %

Related Conditions & MeSH terms

• Colic

Intervention

Dietary Supplement:
• Bactecal® D Liquid
The patients will be randomized into two arms, A and B, in function of the intervention dose

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Astel Medica

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of daily median crying time	By measuring the mean change in crying time	Change from baseline daily median crying time at 28 days
Secondary	Change of the number of crying	By measuring the numbers per day	Change from baseline number of crying at 28 days