Effect of Probiotics on Infantile Colic Symptoms
- Conditions
- Infantile Colic
- Interventions
- Dietary Supplement: ProbioticDietary Supplement: Placebo
- Registration Number
- NCT06385054
- Lead Sponsor
- Lallemand Health Solutions
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Probiotic Probiotic Participants in this group will be randomized to receive the probiotic B. lactis B94 for 4 weeks. Placebo Placebo Participants in this group will be randomized to receive a placebo for 4 weeks.
- Primary Outcome Measures
Name Time Method Change in daily crying duration 4 weeks 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.
- Secondary Outcome Measures
Name Time Method Change in crying patterns 4 weeks 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.
Change in sleep duration 4 weeks Variation in the mean daily duration of the infant's sleep after 1, 2, 3, 4 weeks of intervention in probiotic versus placebo groups.
Change in gut microbiota composition 4 weeks 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).
Probiotic strain recovery 4 weeks Recovery of the probiotic strain in infant stool samples (qPCR) after 4 weeks of intervention.
Change in maternal quality of life 4 weeks Variation in the maternal score of the mother quality-of-life questionnaire (SF- 36) after 4 weeks of intervention in probiotic versus placebo groups.
Change in bowel habits 4 weeks 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.
Trial Locations
- Locations (9)
Centre Hospitalier de Boulogne-sur-Mer
🇫🇷Boulogne-sur-Mer, France
CHU Caen Normandie
🇫🇷Caen, France
Cabinet privé Dr Regimbart-Trubuil Christine
🇫🇷Bécon-les-Granits, France
CHU Grenoble Alpes
🇫🇷La Tronche, France
Hôpital Saint Vincent de Paul
🇫🇷Lille, France
Centre Hospitalier de Montauban
🇫🇷Montauban, France
CHU de NANTES
🇫🇷Nantes, France
Biofortis, Unité d'investigation Clinique
🇫🇷Saint-Herblain, France
Centre Hospitalier du val d'Ariège
🇫🇷Saint-Jean-de-Verges, France