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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05052476

Acronym

BACTECOLIC

Enrollment

Registered

2021-09-22

Start date

2022-04-08

Completion date

2023-10-16

Last updated

2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colic

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.

Interventions

DIETARY_SUPPLEMENTBactecal® D Liquid

The patients will be randomized into two arms, A and B, in function of the intervention dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Weeks to 8 Weeks

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 %

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026