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

NCT05052476 | Completed

• 1 other identifier: BACTECOLIC
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Colic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change of daily median crying time

  Change from baseline daily median crying time at 28 days

• Change of the number of crying

  Change from baseline number of crying at 28 days

Study Arms (2)

Open label Bactecal® D Liquid 1 dose

EXPERIMENTAL

Patients will receive 1 dose of Bactecal® D Liquid by day which corresponds to 2 ml of product

Dietary Supplement: Bactecal® D Liquid

Open label Bactecal® D Liquid 2 doses

EXPERIMENTAL

Patients will receive 2 doses of Bactecal® D Liquid by day which correspond to 4 ml of product.

Dietary Supplement: Bactecal® D Liquid

Interventions

Bactecal® D Liquid DIETARY_SUPPLEMENT

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

Open label Bactecal® D Liquid 1 dose; Open label Bactecal® D Liquid 2 doses

Eligibility Criteria

• Age: 2 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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 %

Sponsors & Collaborators

• Astel Medica: lead

Study Sites (1)

UZ Brussel

Brussels, Belgium

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 22, 2021
• Study Start: April 8, 2022
• Primary Completion: October 8, 2023
• Study Completion: October 16, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)