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

• Sponsor: Astel Medica (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05052476
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.8
• Patients Per Site Per Month: 5.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colic	Dietary Supplement: Bactecal® D Liquid	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic
• Actual Study Start Date: Apr 8, 2022
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in parent quality of life (QoL) score [Change from baseline parent QoL score at 28 days]

   By measuring parent quality of Life (QoL) score. Scale from 1 (minimum) to 7 (maximum). Higher scores mean a better outcome.

Secondary Outcome Measures

1. Change of daily median crying time [Change from baseline daily median crying time at 28 days]

   By measuring the mean change in crying time

2. Change of the number of crying [Change from baseline number of crying at 28 days]

   By measuring the numbers per day

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Weeks to 8 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 %

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Brussel	Brussel		Belgium

Sponsors and Collaborators

• Astel Medica

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Astel Medica
• ClinicalTrials.gov Identifier: NCT05052476
• Other Study ID Numbers: BACTECOLIC
• First Posted: Sep 22, 2021
• Last Update Posted: Apr 29, 2022
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colic

Study Results

No Results Posted as of Apr 29, 2022