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

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.

Study Overview

• Status: Completed
• Conditions: Colic
• Intervention / Treatment: Dietary supplement: Bactecal® D Liquid

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium
    • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 1 month (Child)
• Accepts Healthy Volunteers: No

Description

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 %

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: Bactecal® D Liquid; The patients will be randomized into two arms, A and B, in function of the intervention dose
Experimental: 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.	Dietary supplement: Bactecal® D Liquid; The patients will be randomized into two arms, A and B, in function of the intervention dose

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Astel Medica

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Actual): October 8, 2023
• Study Completion (Actual): October 16, 2023

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: BACTECOLIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No