An interventional study of Probiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/day and Placebo: matching oil formulation without L. reuteri in Infantile Colic, sponsored by Federico II University. Recruiting at 1 site in Italy. Open to participants aged 3 Weeks to 12 Weeks. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Federico II University · Not applicable, Interventional, and Treatment
Academic, independent, non-commercial, multicenter study sponsored by the Department of Translational Medical Sciences (DISMET), University of Naples Federico II. The study evaluates whether daily oral supplementation with Limosilactobacillus reuteri DSM 17938 and BG-R46 reduces crying and fussing time more rapidly than an indistinguishable placebo in otherwise healthy infants with Rome IV infantile colic.
Eligible participants will meet the clinical description for having infant colic. Participants will be assessed for eligibility at the screening visit and must meet all specified inclusion and exclusion criteria. Based on screening examinations, the individual Family Pediatrician (PLS) is solely responsible for determining clinical eligibility and making the final enrollment decision, which will be documented on the Participant Screening and Enrolment Log. The Scientific Coordinator will exclusively monitor aggregate screening logs and enrollment targets across all active sites, without direct involvement in the clinical selection. Fifty infants will be randomized 1:1 to probiotic or placebo. Each participant will complete a 7-day run-in, 21 days of treatment and 7 days of safety follow-up.
153 studies on the registry are indexed under Colic; 19 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 127 interventional studies indexed under Colic.
Browse Colic studies →Federico II University is the lead sponsor of 366 studies on the registry; 61 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Probiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/day, 5 oral drops once daily for 21 days
Dietary Supplement: Probiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/day
Placebo: matching oil formulation without L. reuteri, 5 oral drops once daily for 21 days.
Dietary Supplement: Placebo: matching oil formulation without L. reuteri
5 oral drops once daily for 21 days.
5 oral drops once daily for 21 days.
Daily total crying and fussing time at day 7
Total infant crying and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary
Time frame: 7 days after initiation of intervention
Change in daily total crying and fussing time from baseline to day 7
Total infant crying duration and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary
Time frame: At Day 0 and at day 7 of intervention
Change in daily total crying and fussing time from baseline to every day during 21days of treatment
Total infant crying duration and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary
Time frame: During 21 days of treatment
Proportion of responder patients assessed using a parent-completed daily sleep diary (Baby's Day Diary)
Proportion of patients responders to the treatment, defined as the number of infants with ≥50% reduction in crying and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary
Time frame: During the first 21 days of treatment
Sleeping time
Total infant sleep duration, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary
Time frame: During the first 21 days of treatment
PedsQL Family Impact Module
Changes in PedsQL Family Impact Module range 0-100 (with higher scores reflecting better functioning) from baseline to Days 7 and 21
Time frame: During 21 days of treatment
Maternal Edinburgh Postnatal Depression Scale score
Changes in Maternal Edinburgh Postnatal Depression Scale score evaluation Total score range: 0 to 30 (higher score on the Edinburgh Postnatal Depression Scale (EPDS) indicates a greater severity of symptoms) from baseline to Days 7 and 21
Time frame: During 21 days of treatment
Number of participants experiencing adverse events and serious adverse events.
Number of participants experiencing at least one adverse event (AE) or serious adverse event (SAE) during the study. Events will be recorded and characterized according to type, severity, seriousness, and relationship to the study intervention.
Time frame: From initiation of the intervention (Day 1) through Day 28.Adverse events, serious adverse events
Body temperature
body temperature (°C)
Time frame: At day 0, 21 and 28
Heart rate
heart rate (BPM)
Time frame: At day 0, 21 and 28
Respiratory rate
Respiratory rate/minute
Time frame: At day 0, 21 and 28
Blood pressure
blood pressure (mmHg)
Time frame: At day 0, 21 and 28
Height
Height in cm
Time frame: At day 0, 21 and 28
Weight
Weight in Kg
Time frame: At day 0, 21 and 28
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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