A Phase 2 interventional study of Probiotic and Placebo in Infantile Colic, sponsored by Lallemand Health Solutions. Recruiting at 10 sites in France. Open to participants aged Up to 8 Weeks. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by Lallemand Health Solutions · Phase 2, Interventional, and Supportive care
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.
153 studies on the registry are indexed under Colic; 19 are open to participants now.
This study's planned enrollment of 70 is below the median of 80 across 127 interventional studies indexed under Colic.
Browse Colic studies →Lallemand Health Solutions is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
I1. Healthy male or female. I2. Age ≤ 8 weeks old. I3. Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behavior for 3 or more hours per day, during 3 or more days in 7 days.
I4. Exclusively breastfeeding and planning to breastfeed for the duration of the study.
I5. With a written informed consent signed by the father and mother or legal guardian.
I6. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and scheduled telephone calls.
I7. At least one of the legal representatives is affiliated with a social security scheme.
Exclusion Criteria:
E1. Birthweight \< 2500 g. E2. Gestational age \< 37 weeks. E3. Apgar score at 5 minutes \< 7. E4. Partially or fully formula fed infants except for the 4 first days after birth.
E5. Stunted growth/weight loss (\< 100 g/week from birth to last reported). E6. Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases, or gastrointestinal malformations.
E7. Diagnosed or reported fever and/or infectious diseases, or current systemic infections, or history of congenital infections.
E8. Genetic diseases and chromosomal abnormalities. E9. Metabolic diseases or pancreatic insufficiency. E10. Immunodeficiency. E11. Neurological diseases. E12. Suspected or confirmed food allergies and intolerances. E13. Mother who consumed antacid medications (proton pump inhibitor and H2 receptor antagonist) within the month before birth and intend to consume any during the trial.
E14. Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening and during the trial.
E15. Use of anti-colic medication at any time from birth to the moment of screening.
E16. Use of probiotics and prebiotics supplements by the mother between the birth of their infant and the moment of screening and intend to consume any during the trial.
E17. Currently enrolled in another clinical study or having participated in another clinical from birth to the moment of screening.
E18. Whose legal representatives have psychological or linguistic incapability to sign the informed consent.
E19. Impossibility to contact the legal representatives in case of emergency.
Participants in this group will be randomized to receive the probiotic B. lactis B94 for 4 weeks.
Dietary Supplement: Probiotic
Participants in this group will be randomized to receive a placebo for 4 weeks.
Dietary Supplement: Placebo
Participants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water.
Participants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water.
Change 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).
Time 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
Safety and tolerability of the intervention
Assessment of the safety and tolerability of the probiotic formulation and the placebo through records of AEs/SAEs, growth parameters and number of unscheduled visits to the doctor.
Time frame: 5 weeks
Change in fecal immune markers and proteins
Difference in the concentration of fecal immune markers and proteins after 4 weeks of intervention in probiotic versus placebo groups.
Time frame: 4 weeks
Plan to share: No
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Studies of the drug tested here: Probiotic
Lallemand Health Solutions