Effect of Probiotics on Infantile Colic Symptoms (EPIC)

Effect of Probiotics on Infantile Colic Symptoms: a Randomized, Double-blind, Placebo-controlled Study (EPIC).

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.

Study Overview

• Status: Recruiting
• Conditions: Infantile Colic
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lya Blais, M.Sc.; Phone Number: + 1-514-283-1387; Email: lblais@lallemand.com
• Study Contact Backup: Name: Basile Frilley; Email: epic-oc@biofortis.fr

Study Locations

• France
  • Boulogne-sur-Mer, France, 62200
    • Recruiting
    • Centre Hospitalier de Boulogne-sur-mer
    • Principal Investigator: Mohamad Hage, MD
  • Bécon-les-Granits, France, 49370
    • Not yet recruiting
    • Cabinet privé Dr Regimbart-Trubuil Christine
    • Principal Investigator: Christine Regimbart-Trubuil, MD
  • Caen, France, 14033
    • Not yet recruiting
    • CHU Caen Normandie
    • Principal Investigator: Edouard Lacotte, MD
  • La Tronche, France, 38700
    • Not yet recruiting
    • CHU Grenoble Alpes
    • Principal Investigator: Ellen Katranji, MD
  • Lille, France, 59000
    • Recruiting
    • Hopital Saint Vincent de Paul
    • Principal Investigator: Pr. Nicholas Kalach, MD
  • Montauban, France, 82000
    • Not yet recruiting
    • Centre Hospitalier de Montauban
    • Principal Investigator: Sabine Charpentier, MD
  • Nantes, France, 44000
    • Not yet recruiting
    • CHU de Nantes
    • Principal Investigator: Hugues Piloquet, MD
  • Paris, France, 75012
    • Not yet recruiting
    • Biofortis, Unité d'Investigation Clinique
    • Principal Investigator: Stéphanie Cavigoli, MD
  • Saint-Herblain, France, 44800
    • Not yet recruiting
    • Biofortis, Unité d'Investigation Clinique
    • Principal Investigator: Isabelle Metreau, MD
  • Saint-Jean-de-Verges, France, 09000
    • Recruiting
    • Centre Hospitalier du val d'Ariège
    • Principal Investigator: Lucas PERCHERON, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 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.
Experimental: Probiotic; Participants in this group will be randomized to receive the probiotic B. lactis B94 for 4 weeks.	Dietary supplement: Probiotic; Participants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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).	4 weeks
Probiotic strain recovery	Recovery of the probiotic strain in infant stool samples (qPCR) after 4 weeks of intervention.	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	4 weeks

Collaborators and Investigators

• Sponsor: Lallemand Health Solutions
• Collaborators: BioFortis
• Investigators: Principal Investigator: Pr. Nicholas Kalach, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Probiotics; Gut Microbiota; Infant Colic; Sleep Duration; EPIC; Crying Time
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: L-027; 2023-A02612-43 (Registry Identifier: ID-RCB); PEC23063 (Other Identifier: Biofortis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No