ColicBACTECOLICNCT05052476

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

A study testing Bactecal® D Liquid in people with Colic, run by Astel Medica at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 2 to 8 weeks
Conditions the study is for: Colic
What is being tested?: Bactecal® D Liquid
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteBelgium
Study dates: 8 Apr 2022to 16 Oct 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 8 weeks
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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 %

Trial locations and contacts

1 site in 1 country.

Belgium1 site

UZ Brussel
Brussels

Other trials in Belgium

About this study

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
Being tested: Bactecal® D Liquid
Medical subject headings: Colic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bactecal® D LiquidDietary supplement
The patients will be randomized into two arms, A and B, in function of the intervention dose

Study groups in NCT05052476
Study group	Role	What they receive
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 Receives: 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. Receives: Dietary Supplement: Bactecal® D Liquid

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Change from baseline parent QoL score at 28 days

Secondary outcomes (2)

Change of daily median crying time
By measuring the mean change in crying time
Measured: Change from baseline daily median crying time at 28 days
Change of the number of crying
By measuring the numbers per day
Measured: Change from baseline number of crying at 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 202216 Oct 2023

First posted22 Sep 2021
Study start8 Apr 2022
Primary completion8 Oct 2023
Study completion16 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ColicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05052476
Sponsor's protocol ID: BACTECOLIC
Acronym: BACTECOLIC
Status last verified: Jul 2023
First submitted: 9 Sep 2021
Last updated: 28 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
Active, not recruiting
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Infantile Colic
Recruiting
Contribution of Preserving the Superior Left Colic Artery to the Vascularization of the Descending Colon Prior to Colorectal Anastomosis During Left-Sided or Rectal Resections for Colorectal or Ovarian Cancer. (Revascularisation Colique)
Rectal Cancer, Colon Cancer
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic
Recruiting
Use of Bifidobacterium Bifidum in Formula-Fed Infants With Colic, With or Without Atopic Dermatitis
Infant Colic, Atopic Dermatitis

All Colic trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic
ClinicalTrials.gov ID: NCT05052476
Acronym / sponsor ID: BACTECOLIC / BACTECOLIC
Conditions: Colic
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Astel MedicaIndustry (pharma, biotech, devices)
Study start: 8 Apr 2022 (actual)
Primary completion: 8 Oct 2023 (actual)
Study completion: 16 Oct 2023 (actual)
First posted: 22 Sep 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Open label Bactecal® D Liquid 1 dose	Experimental	Dietary Supplement: Bactecal® D LiquidPatients will receive 1 dose of Bactecal® D Liquid by day which corresponds to 2 ml of product
Open label Bactecal® D Liquid 2 doses	Experimental	Dietary Supplement: Bactecal® D LiquidPatients will receive 2 doses of Bactecal® D Liquid by day which correspond to 4 ml of product.

Who may qualify

Ages: 2 to 8 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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 %

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bactecal® D LiquidThe patients will be randomized into two arms, A and B, in function of the intervention dose	Dietary supplement	Open label Bactecal® D Liquid 1 dose, Open label Bactecal® D Liquid 2 doses

Primary outcome

Change in parent quality of life (QoL) score
Time frame: 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.

2 secondary outcomes

Change of daily median crying time
Time frame: Change from baseline daily median crying time at 28 days
Change of the number of crying
Time frame: Change from baseline number of crying at 28 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
Individual participant dataSharing planned: No

Related trials for Colic

Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
Active, not recruiting
Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
Infantile Colic
Recruiting
Contribution of Preserving the Superior Left Colic Artery to the Vascularization of the Descending Colon Prior to Colorectal Anastomosis During Left-Sided or Rectal Resections for Colorectal or Ovarian Cancer. (Revascularisation Colique)
Rectal Cancer, Colon Cancer
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic
Recruiting
Use of Bifidobacterium Bifidum in Formula-Fed Infants With Colic, With or Without Atopic Dermatitis
Infant Colic, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bactecal® D Liquid in people with Colic, run by Astel Medica at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in parent quality of life (QoL) score (time frame: Change from baseline parent QoL score at 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05052476.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.