Probiotics for reducing crying in infants with colic
Effect of Probiotics on Infantile Colic Symptoms: a Randomized, Double-blind, Placebo-controlled Study (EPIC).
PHASE2 · Lallemand Health Solutions · NCT06385054
This study is testing if a probiotic can help reduce crying in babies with colic compared to a placebo.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | N/A to 8 Weeks |
| Sex | All |
| Sponsor | Lallemand Health Solutions (industry) |
| Locations | 10 sites (Bécon-les-Granits and 9 other locations) |
| Trial ID | NCT06385054 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of the probiotic B. lactis B94 on infants diagnosed with infantile colic. Participants will be randomly assigned to receive either the probiotic or a placebo for a duration of four weeks, following a one-week baseline period. The study will include three in-person visits and four phone calls to monitor progress and collect data on crying duration. The primary outcome is the reduction in crying time among those receiving the probiotic compared to the placebo group.
Who should consider this trial
Good fit: Ideal candidates are healthy infants aged 8 weeks or younger who are exclusively breastfeeding and meet the criteria for infantile colic.
Not a fit: Patients who are partially or fully formula-fed, or those with certain medical conditions such as gastroesophageal reflux disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive treatment option for reducing crying time in infants suffering from colic.
How similar studies have performed: Previous studies have shown promising results with probiotics in managing infantile colic, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bécon-les-Granits and 9 other locations
- Cabinet privé Dr Regimbart-Trubuil Christine — Bécon-les-Granits, France (NOT_YET_RECRUITING)
- Centre Hospitalier de Boulogne-sur-Mer — Boulogne-sur-Mer, France (RECRUITING)
- CHU Caen Normandie — Caen, France (NOT_YET_RECRUITING)
- CHU Grenoble Alpes — La Tronche, France (NOT_YET_RECRUITING)
- Hôpital Saint Vincent de Paul — Lille, France (RECRUITING)
- Centre Hospitalier de Montauban — Montauban, France (NOT_YET_RECRUITING)
- CHU de NANTES — Nantes, France (NOT_YET_RECRUITING)
- Biofortis, Unité d'investigation Clinique — Paris, France (NOT_YET_RECRUITING)
- Biofortis, Unité d'investigation Clinique — Saint-Herblain, France (NOT_YET_RECRUITING)
- Centre Hospitalier du val d'Ariège — Saint-Jean-de-Verges, France (RECRUITING)
Study contacts
- Principal investigator: Pr. Nicholas Kalach, MD — Groupement des Hôpitaux de l'Institut Catholique de Lille
- Study coordinator: Lya Blais, M.Sc.
- Email: lblais@lallemand.com
- Phone: + 1-514-283-1387
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infantile Colic, EPIC, Infant Colic, Probiotics, Crying Time, Gut Microbiota, Sleep Duration