Clinical trial NCT06385054: Effect of Probiotics on Infantile Colic Symptoms
Official title: Effect of Probiotics on Infantile Colic Symptoms: a Randomized, Double-blind, Placebo-controlled Study (EPIC).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Infantile Colic
Keywords: EPIC
Infant Colic
Probiotics
Crying Time
Gut Microbiota
Sleep Duration
Lead sponsor: Lallemand Health Solutions
Sponsor class: INDUSTRY
Collaborators: name: BioFortis
First posted: 2024-04-25
Enrollment: 70
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in daily crying duration
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in crying patterns
timeFrame: 4 weeks
measure: Change in sleep duration
timeFrame: 4 weeks
measure: Change in maternal quality of life
timeFrame: 4 weeks
measure: Change in bowel habits
timeFrame: 4 weeks
measure: Change in gut microbiota composition
timeFrame: 4 weeks
measure: Probiotic strain recovery
timeFrame: 4 weeks
Other outcomes:
measure: Safety and tolerability of the intervention
timeFrame: 5 weeks
measure: Change in fecal immune markers and proteins
timeFrame: 4 weeks
Locations:
city: Boulogne-sur-Mer
country: France
facility: Centre Hospitalier de Boulogne-sur-Mer
city: Bécon-les-Granits
country: France
facility: Cabinet privé Dr Regimbart-Trubuil Christine
city: Caen
country: France
facility: CHU Caen Normandie
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul
city: Montauban
country: France
facility: Centre Hospitalier de Montauban
city: Nantes
country: France
facility: CHU de NANTES
city: Paris
country: France
facility: Biofortis, Unité d'investigation Clinique
city: Saint-Herblain
country: France
facility: Biofortis, Unité d'investigation Clinique
city: Saint-Jean-de-Verges
country: France
facility: Centre Hospitalier du val d'Ariège
Study officials:
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille
name: Pr. Nicholas Kalach, MD
role: PRINCIPAL_INVESTIGATOR
References: