protocolSection identificationModule nctId: NCT06385054, orgStudyIdInfo id: L-027, secondaryIdInfos id: 2023-A02612-43, type: REGISTRY, domain: ID-RCB, secondaryIdInfos id: PEC23063, type: OTHER, domain: Biofortis, briefTitle: Effect of Probiotics on Infantile Colic Symptoms, acronym: EPIC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: Lallemand Health Solutions, class: INDUSTRY, collaborators name: BioFortis, descriptionModule briefSummary: The aim of this clinical trial is to assess the impact of a probiotic formulation 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., conditionsModule conditions: Infantile Colic, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Probiotic, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in daily crying duration, secondaryOutcomes measure: Change in crying patterns, secondaryOutcomes measure: Change in sleep duration, secondaryOutcomes measure: Change in maternal quality of life, secondaryOutcomes measure: Change in bowel habits, secondaryOutcomes measure: Change in gut microbiota composition, secondaryOutcomes measure: Probiotic strain recovery, otherOutcomes measure: Safety and tolerability of the intervention, otherOutcomes measure: Change in fecal immune markers and proteins, eligibilityModule sex: ALL, maximumAge: 8 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Centre Hospitalier de Boulogne-sur-Mer, city: Boulogne-sur-Mer, zip: 62200, country: France, contacts name: Mohamad Hage, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.71667, lon: 1.61667, locations facility: Cabinet privé Dr Regimbart-Trubuil Christine, city: Bécon-les-Granits, zip: 49370, country: France, contacts name: Christine Regimbart-Trubuil, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.50134, lon: -0.8, locations facility: CHU Caen Normandie, city: Caen, zip: 14033, country: France, contacts name: Edouard Lacotte, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 49.18585, lon: -0.35912, locations facility: CHU Grenoble Alpes, city: La Tronche, zip: 38700, country: France, contacts name: Ellen Katranji, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.20429, lon: 5.73645, locations facility: Hôpital Saint Vincent de Paul, city: Lille, zip: 59000, country: France, contacts name: Pr. Nicholas Kalach, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Centre Hospitalier de Montauban, city: Montauban, zip: 82000, country: France, contacts name: Sabine Charpentier, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.01667, lon: 1.35, locations facility: CHU de NANTES, city: Nantes, zip: 44000, country: France, contacts name: Hugues Piloquet, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.21725, lon: -1.55336, locations facility: Biofortis, Unité d'investigation Clinique, city: Paris, zip: 75012, country: France, contacts name: Stéphanie Cavigoli, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Biofortis, Unité d'investigation Clinique, city: Saint-Herblain, zip: 44800, country: France, contacts name: Isabelle Metreau, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.21765, lon: -1.64841, locations facility: Centre Hospitalier du val d'Ariège, city: Saint-Jean-de-Verges, zip: 09000, country: France, contacts name: Lucas Percheron, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.01371, lon: 1.61076, hasResults: False