Effect of Probiotics on Infantile Colic Symptoms
EPIC
3 other identifiers
interventional
70
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2024
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2024
CompletedFirst Posted
Study publicly available on registry
April 25, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
ExpectedAugust 16, 2024
August 1, 2024
1.5 years
April 23, 2024
August 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
4 weeks
Secondary Outcomes (6)
Change in crying patterns
4 weeks
Change in sleep duration
4 weeks
Change in maternal quality of life
4 weeks
Change in bowel habits
4 weeks
Change in gut microbiota composition
4 weeks
- +1 more secondary outcomes
Other Outcomes (2)
Safety and tolerability of the intervention
5 weeks
Change in fecal immune markers and proteins
4 weeks
Study Arms (2)
Probiotic
EXPERIMENTALParticipants in this group will be randomized to receive the probiotic B. lactis B94 for 4 weeks.
Placebo
PLACEBO COMPARATORParticipants in this group will be randomized to receive a placebo for 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lallemand Health Solutionslead
- BioFortiscollaborator
Study Sites (10)
Cabinet privé Dr Regimbart-Trubuil Christine
Bécon-les-Granits, 49370, France
Centre Hospitalier de Boulogne-sur-Mer
Boulogne-sur-Mer, 62200, France
CHU Caen Normandie
Caen, 14033, France
CHU Grenoble Alpes
La Tronche, 38700, France
Hôpital Saint Vincent de Paul
Lille, 59000, France
Centre Hospitalier de Montauban
Montauban, 82000, France
CHU de NANTES
Nantes, 44000, France
Biofortis, Unité d'investigation Clinique
Paris, 75012, France
Biofortis, Unité d'investigation Clinique
Saint-Herblain, 44800, France
Centre Hospitalier du val d'Ariège
Saint-Jean-de-Verges, 09000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pr. Nicholas Kalach, MD
Groupement des Hôpitaux de l'Institut Catholique de Lille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2024
First Posted
April 25, 2024
Study Start
August 1, 2024
Primary Completion
February 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
August 16, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share