Actively Recruiting
Effect of Probiotics on Infantile Colic Symptoms
Led by Lallemand Health Solutions · Updated on 2024-08-16
70
Participants Needed
10
Research Sites
130 weeks
Total Duration
On this page
Sponsors
L
Lallemand Health Solutions
Lead Sponsor
B
BioFortis
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim of this clinical trial is to assess the impact of B. lactis B94 on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention.
CONDITIONS
Official Title
Effect of Probiotics on Infantile Colic Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female infant
- Age 8 weeks or younger
- Diagnosed with infantile colic by Rome IV criteria (crying or fussing 3 or more hours per day, at least 3 days in 7 days)
- Exclusively breastfeeding and planning to continue breastfeeding during the study
- Written informed consent signed by both parents or legal guardian
- Parents willing to complete questionnaires, records, diaries, clinical visits, and scheduled phone calls
- At least one legal representative affiliated with a social security scheme
You will not qualify if you...
- Birthweight less than 2500 grams
- Gestational age less than 37 weeks
- Apgar score below 7 at 5 minutes after birth
- Partially or fully formula fed infants except during the first 4 days after birth
- Growth stunting or weight loss less than 100 grams per week from birth to last report
- Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases, or gastrointestinal malformations
- Fever, infectious diseases, current systemic infections, or history of congenital infections
- Genetic or chromosomal abnormalities
- Metabolic diseases or pancreatic insufficiency
- Immunodeficiency or neurological diseases
- Suspected or confirmed food allergies or intolerances
- Mother consumed antacid medications within one month before birth and plans to use during trial
- Infant used probiotics, prebiotics, antibiotics, or gastric acid inhibitors from birth to screening and during trial
- Infant used anti-colic medication from birth to screening
- Mother used probiotics or prebiotics supplements from birth to screening and plans to use during trial
- Currently enrolled or participated in another clinical study from birth to screening
- Legal representatives unable to sign informed consent due to psychological or language incapacity
- Inability to contact legal representatives in case of emergency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Cabinet privé Dr Regimbart-Trubuil Christine
Bécon-les-Granits, France, 49370
Not Yet Recruiting
2
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, France, 62200
Actively Recruiting
3
CHU Caen Normandie
Caen, France, 14033
Not Yet Recruiting
4
CHU Grenoble Alpes
La Tronche, France, 38700
Not Yet Recruiting
5
Hôpital Saint Vincent de Paul
Lille, France, 59000
Actively Recruiting
6
Centre Hospitalier de Montauban
Montauban, France, 82000
Not Yet Recruiting
7
CHU de NANTES
Nantes, France, 44000
Not Yet Recruiting
8
Biofortis, Unité d'investigation Clinique
Paris, France, 75012
Not Yet Recruiting
9
Biofortis, Unité d'investigation Clinique
Saint-Herblain, France, 44800
Not Yet Recruiting
10
Centre Hospitalier du val d'Ariège
Saint-Jean-de-Verges, France, 09000
Actively Recruiting
Research Team
L
Lya Blais, M.Sc.
CONTACT
B
Basile Frilley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here