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New treatment option for Colic, Infantile
Official title Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With Colic
ClinicalTrials.gov ID: NCT05512234
What this study is testing
- What it's testing
- This is a double-blind, multi-center, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying time.
- 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 3 to 8
You may be able to join if
- Aged between 3-8 weeks at screening.
- Gestational age 37+0 weeks - 42+0 weeks at birth.
- Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the...
- Parents/caregivers/legal guardians are \>18 years.
- Exclusively or predominantly breastfed infants (\> 50 % breast fed).
You likely can't join if
- Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \> 8 times daily, projectile, bilious or bloody...
- Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape...
- Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.
- Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
- Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
- Infants with reported exposure to medications, therapies, or products with the aim to relieve infantile colic including proton pump inhibitors in the...
See the full eligibility criteria
- Aged between 3-8 weeks at screening.
- Gestational age 37+0 weeks - 42+0 weeks at birth.
- Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides.
- Parents/caregivers/legal guardians are \>18 years.
- Exclusively or predominantly breastfed infants (\> 50 % breast fed).
- Willing to maintain current feeding patterns (not change formula/not change ratio of formula:breast milk etc.).
- Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires.
- Infantile colic diagnosed according to Rome IV criteria (face-to-face consult with a physician, parents/caregivers/legal guardians must report that their infant has cried or fussed for 3 or more hours per day, during 3...
- Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
- Parents/caregivers/legal guardians willing and able to give informed consent for their and their infant's participation in the study.
- The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 4 (Day 8), and Visit 6 (Day 22).
- Infant is considered healthy, in the opinion of the investigator following physical exam.
- Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \> 8 times daily, projectile, bilious or bloody emesis).
- Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container \> 12x in breastfed and \>5 in partially breastfed...
- Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.
- Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
- Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
- Infants with reported exposure to medications, therapies, or products with the aim to relieve infantile colic including proton pump inhibitors in the 7 days prior to Screening Visit (V1) and throughout the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Cork, Ireland
- Uppsala, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 3 weeks to 8 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cork, Ireland; Uppsala, Sweden. 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.