Probiotics for reducing crying in infants with colic

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Hospitalier de Boulogne-sur-Mer
  Boulogne-sur-Mer, France Recruiting
• Hôpital Saint Vincent de Paul
  Lille, France Recruiting
• Centre Hospitalier du val d'Ariège
  Saint-Jean-de-Verges, France Recruiting
• Cabinet privé Dr Regimbart-Trubuil Christine
  Bécon-les-Granits, France Not yet recruiting
• CHU Caen Normandie
  Caen, France Not yet recruiting
• CHU Grenoble Alpes
  La Tronche, France Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Probiotics for infant colic: does daily L. reuteri help crying time?

  This study tests whether giving healthy infants with Rome IV–defined colic a daily probiotic (L. reuteri) reduces crying and fussing more quickly than a placebo.

  Recruiting Federico II University · Naples · NCT07894445

• BioAmicus Complete for infants with colic, reflux, constipation, or loose stools (0–24 months)

  This study will see if the multistrain probiotic BioAmicus Complete can help reduce caregiver‑reported tummy symptoms in infants aged 0–24 months.

  Recruiting Haiphong University of Medicine and Pharmacy · Haiphong, Hai Phong · NCT07148583

• Do oral probiotic strains reach the vagina in healthy women?

  We will test whether taking oral probiotic supplements leads to those probiotic strains appearing in the vagina of healthy women aged 18 to 50.

  Recruiting Phase 2 Lallemand Health Solutions · Montreal · NCT07246161

• Exploring how probiotics affect energy metabolism after meals in older adults

  This study is testing if taking probiotics can help older adults who are moderately overweight improve their energy and metabolism after meals.

  Recruiting Phase 2 Lallemand Health Solutions · Pierre-Bénite, Auvergne-Rhône-Alpes · NCT06786052

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.