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New treatment option for Colic
Official title Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.
ClinicalTrials.gov ID: NCT07347743
What this study is testing
- What it's testing
- This study aims to demonstrate that a dietary supplement, which contains two strains of the probiotic L. reuteri is safe, well tolerated and able to reduce the incidence of colic and excessive crying/fussiness in healthy infants.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 14. Healthy volunteers may be eligible.
You may be able to join if
- Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks.
- Infant is healthy at the time of pre-examination.
- Infant is aged between 1 and 14 days old at the time of inclusion.
- Legal guardian(s) are able and willing to follow the study instructions
- Infant is suitable for participation in the study according to the investigator/ study personnel
You likely can't join if
- No legal guardian's command of any local language
- Infant with a major congenital anomaly (i.e. anal atresia, trisomy 21) or suspicion of any chronic disorder or disease (i.e. Hirschsprung's disease...
- Infant is suffering from congenital or acquired immunodeficiency
- Infant is suffering from an infection at the time of pre-examination or previous 7 days
- Infant is admitted post-partum to the neonatal intensive care unit
- Infant is not suitable for participation in the study according to the study personnel´s opinion
See the full eligibility criteria
- Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks.
- Infant is healthy at the time of pre-examination.
- Infant is aged between 1 and 14 days old at the time of inclusion.
- Legal guardian(s) are able and willing to follow the study instructions
- Infant is suitable for participation in the study according to the investigator/ study personnel
- Legal guardian(s) willing to refrain products containing probiotics for their infant, from baseline (visit 1) throughout the study period (visit 3).
- Informed written consent given by parent / legal guardian
- No legal guardian's command of any local language
- Infant with a major congenital anomaly (i.e. anal atresia, trisomy 21) or suspicion of any chronic disorder or disease (i.e. Hirschsprung's disease, metabolic disorder)
- Infant is suffering from congenital or acquired immunodeficiency
- Infant is suffering from an infection at the time of pre-examination or previous 7 days
- Infant is admitted post-partum to the neonatal intensive care unit
- Infant is not suitable for participation in the study according to the study personnel´s opinion
The study team makes the final eligibility decision.
Where it's taking place
- Jette, Brussels Capital, Belgium
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 day to 14 days. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jette, Brussels Capital, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.