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

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 multicenter, randomized trial evaluates whether daily oral L. reuteri at 2 × 10^8 CFU/day shortens crying and fussing in otherwise healthy infants with Rome IV infantile colic. Fifty infants aged 3–12 weeks will be randomized 1:1 to probiotic or placebo and will complete a 7-day run-in, 21 days of treatment, and 7 days of safety follow-up. Eligibility is confirmed by a family pediatrician with oversight from a scientific coordinator monitoring enrollment targets. The primary aim is to determine if the probiotic accelerates improvement in colic symptoms compared with placebo, using caregiver diaries and standardized assessments. Safety monitoring will track adverse events during the treatment and follow-up periods.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 3-12 weeks at screening;
* gestational age 37+0 to 42+0 weeks;
* birth weight appropriate or large for gestational age;
* parent/caregiver/legal guardian older than 18 years;
* exclusive or predominant breastfeeding (\>50%);
* willingness to maintain feeding pattern and complete diaries and questionnaires;
* physician-confirmed Rome IV infantile colic, parental report of ≥3 hours of crying/fussing per day on ≥3 days in the prior week, and ≥3 hours in at least one 24-hour period documented in the run-in diary;
* written informed consent; mother available for scheduled visits; infant otherwise clinically healthy.

Exclusion Criteria:

* Severe gastroesophageal reflux (as defined in the protocol);
* failure to thrive;
* intrauterine growth restriction;
* hematochezia;
* significant diarrhea or fever ≥38 °C;
* congenital heart disease, immunodeficiency, asplenia, malignancy, cystic fibrosis or liver disease;
* probiotic or systemic/oral antibiotic use in the 7 days before screening or anticipated use during the study;
* use of treatments for infantile colic; including proton pump inhibitors; in the 7 days before screening or during the study.
* Infant and mother must not participate concurrently in another interventional clinical study.

Where it's running

• Family pediatricians
  Naples, Italy Recruiting

Study contacts

• Study coordinator: Robeto Berni Canani, PhD, MD
• Email: berni@unina.it
• Phone: +390817462680

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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.