Actively Recruiting
Effect of Probiotics on Infantile Colic Symptoms: a Randomized, Double-blind, Placebo-controlled Study
Led by Lallemand Health Solutions · Updated on 2024-08-16
70
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
Sponsors
L
Lallemand Health Solutions
Lead Sponsor
B
BioFortis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of the probiotic B. lactis B94 on infants with infantile colic. The study aims to see if this probiotic can reduce the duration of crying in infants compared to a placebo. This is a randomized, double-blind, placebo-controlled trial designed to provide clear evidence on the potential benefits of B. lactis B94 for infantile colic symptoms. Participants will be randomly assigned to one of two groups: one receiving the probiotic B. lactis B94 and the other receiving a placebo. Both groups will take one sachet daily, dissolved in 10 ml of lukewarm water, for 4 weeks. The study includes a 1-week baseline period before treatment and a 1-week follow-up after the intervention. The trial involves three in-person visits and four phone calls. During the 6-week participation, caregivers will complete questionnaires, keep diaries, and attend scheduled visits and calls to monitor the infant's crying, sleep, bowel habits, and quality of life. Researchers will measure changes in daily crying duration, crying patterns, sleep time, gut bacteria composition, and probiotic recovery. Safety and adherence will be tracked throughout the study, ensuring detailed observation of all participants.
CONDITIONS
Brief Title
Effect of Probiotics on Infantile Colic Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female infants
- Age 8 weeks or younger
- Diagnosed with infantile colic by Rome IV criteria (crying or fussing 3+ hours per day for 3+ days in 7 days)
- Exclusively breastfeeding and planning to continue during the study
- Written informed consent signed by both parents or legal guardian
- Parents willing to complete study questionnaires, records, diaries, visits, and calls
- At least one legal representative affiliated with social security
You will not qualify if you...
- Birthweight less than 2500 grams
- Gestational age less than 37 weeks
- Apgar score below 7 at 5 minutes
- Partially or fully formula-fed infants, except during first 4 days after birth
- Stunted growth or weight loss less than 100 grams/week from birth
- Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases, or gastrointestinal malformations
- Fever, infectious diseases, systemic infections, or history of congenital infections
- Genetic diseases or chromosomal abnormalities
- Metabolic diseases or pancreatic insufficiency
- Immunodeficiency
- Neurological diseases
- Suspected or confirmed food allergies or intolerances
- Maternal use of antacid medications within 1 month before birth and planned use during trial
- Infant use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors from birth until screening and during trial
- Use of anti-colic medication from birth until screening
- Maternal use of probiotics or prebiotics since birth until screening and planned use during trial
- Participation in another clinical study from birth until screening
- Legal representatives unable to provide informed consent due to psychological or language issues
- Inability to contact legal representatives in case of emergency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 week
Participants undergo a 1-week baseline period without intervention to establish initial symptom patterns.
1 baseline visit (in-person)
Duration - 4 weeks
Participants take either the probiotic or placebo daily for 4 weeks to evaluate effects on infantile colic symptoms.
2 in-person visits and 4 phone calls during the treatment period
Duration - 1 week
Participants are monitored for 1 week after treatment to assess lasting effects.
1 follow-up visit (in-person)
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.
B
Basile Frilley
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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