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.
The goal of this clinical trial is to evaluate the potential beneficial effects of B. lactis B94 on the symptoms of infantile colic. Participants diagnosed with infantile colic will be recruited to participate in this randomized, double-blind, placebo controlled, two-armed parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period. The study will consist of 3 in-person visits and 4 phone calls.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
70
Cabinet privé Dr Regimbart-Trubuil Christine
Bécon-les-Granits, France
NOT_YET_RECRUITINGCentre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, France
RECRUITINGChange in daily crying duration
Proportion of infants who experience a decrease of mean daily crying duration of at least 50% after 4 weeks of intervention, in placebo versus probiotic groups.
Time frame: 4 weeks
Change in crying patterns
Proportion of infants who experience a decrease of mean daily crying duration of at least 50% or at least 25%, mean daily number of crying episodes and variation in mean daily crying duration after 1, 2, 3, 4 weeks of intervention, in placebo versus probiotic groups.
Time frame: 4 weeks
Change in sleep duration
Variation in the mean daily duration of the infant's sleep after 1, 2, 3, 4 weeks of intervention in probiotic versus placebo groups.
Time frame: 4 weeks
Change in maternal quality of life
Variation in the maternal score of the mother quality-of-life questionnaire (SF- 36) after 4 weeks of intervention in probiotic versus placebo groups.
Time frame: 4 weeks
Change in bowel habits
General perception of colic evolution (total recovery / better / worse / no change), infant bowel movement frequency (mean daily number of stools) and stool consistency (rate (%), Amsterdam infant stool scale) after 1, 2, 3, 4 weeks of intervention in probiotic versus placebo groups.
Time frame: 4 weeks
Change in gut microbiota composition
Gut microbiota composition (α-diversity, β-diversity, and relative abundance at the genus level) and variation in gut microbiota composition (α-diversity, β-diversity, and relative abundance at the genus level) after 4 weeks of intervention in probiotic versus placebo groups (via 16S sequencing).
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CHU Caen Normandie
Caen, France
CHU Grenoble Alpes
La Tronche, France
NOT_YET_RECRUITINGHôpital Saint Vincent de Paul
Lille, France
RECRUITINGCentre Hospitalier de Montauban
Montauban, France
NOT_YET_RECRUITINGCHU de NANTES
Nantes, France
NOT_YET_RECRUITINGBiofortis, Unité d'investigation Clinique
Paris, France
NOT_YET_RECRUITINGBiofortis, Unité d'investigation Clinique
Saint-Herblain, France
NOT_YET_RECRUITINGCentre Hospitalier du val d'Ariège
Saint-Jean-de-Verges, France
RECRUITINGTime frame: 4 weeks
Probiotic strain recovery
Recovery of the probiotic strain in infant stool samples (qPCR) after 4 weeks of intervention.
Time frame: 4 weeks