Effect of Probiotics on Infantile Colic Symptoms

Infantile Colic Clinical Trial

— EPIC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06385054
• Other study ID #: L-027
• Secondary ID: 2023-A02612-43PE
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: February 2027

Study information

• Verified date: April 2024
• Source: Lallemand Health Solutions
• Contact: Lya Blais, M.Sc.
• Phone: + 1-514-283-1387
• Email: lblais[@]lallemand.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The goal of this clinical trial is to evaluate the potential beneficial effects of a probiotic formulation 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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: February 2027
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 8 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Colic
• Infantile Colic

Intervention

Dietary Supplement:
• Probiotic
Participants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water.
• Placebo
Participants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water.

Locations

Country	Name	City	State
France	Cabinet privé Dr Regimbart-Trubuil Christine	Bécon-les-Granits
France	Centre Hospitalier de Boulogne-sur-Mer	Boulogne-sur-Mer
France	CHU Caen Normandie	Caen
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	Paris
France	Biofortis, Unité d'investigation Clinique	Saint-Herblain
France	Centre Hospitalier du val d'Ariège	Saint-Jean-de-Verges

Sponsors (2)

Lead Sponsor	Collaborator
Lallemand Health Solutions	BioFortis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in gut microbiota composition	Gut microbiota composition (a-diversity, ß-diversity, and relative abundance at the genus level) and variation in gut microbiota composition (a-diversity, ß-diversity, and relative abundance at the genus level) after 4 weeks of intervention in probiotic versus placebo groups (via 16S sequencing).	4 weeks
Secondary	Probiotic strain recovery	Recovery of the probiotic strain in infant stool samples (qPCR) after 4 weeks of intervention.	4 weeks