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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

About this trial

This is an interventional treatment trial for Colic

Eligibility Criteria

2 Weeks - 8 Weeks (Child)All SexesDoes not accept healthy volunteers

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

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

NCT ID

NCT05052476

First Posted

September 9, 2021

Last Updated

July 19, 2023

Sponsor

Astel Medica

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

yvan.vandenplas@uzbrussel.be

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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