An interventional study of L. reuteri and Placebo in Colic, Infantile, sponsored by BioGaia AB. Recruiting at 2 sites in 2 countries. Open to participants aged 3 Weeks to 8 Weeks. Per ClinicalTrials.gov, last updated 2025-09-22.
Sponsored by BioGaia AB · Not applicable, Interventional, and Treatment
This is a double-blind, multi-center, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying time.
Prevalence of infantile colic varies according to the definition used but estimates range between 5 % and 26 % of the infant population. To differentiate colic from other, more serious conditions it should be characterized by several clinical features. Infant colic is often accompanied by flushing the face, frown, tensing of the abdomen, clenching of the fists, and drawing up the leg, frequent, prolonged, and intense crying or fussiness in a healthy infant. Even though infant colic is benign and usually self-limiting condition it is a source of major distress for the infant, parents, family, and health care givers.
Despite infant colic occurs frequently, little agreement has been reached on the definition, pathogenesis, or the optimal management strategy for infant colic. Recent systematic reviews and meta-analyses showed that probiotic L. reuteri DSM 17938 supplementation significantly lowered the number of hours of crying and fussing daily. A significant peak effect was seen at 3 weeks in most studies. Interestingly, babies with infant colic were found to have increased evidence of gut inflammation, as evidenced by high levels of the antimicrobial peptide fecal calprotectin; also, the levels of fecal calprotectin declined significantly as the condition resolved.
Exclusion criteria
5 drops administered once daily for 21 days
Dietary Supplement: L. reuteri
5 drops administered once daily for 21 days
Dietary Supplement: Placebo
Dietary supplementation with drops containing L. reuteri once daily for 21 consecutive days
Dietary supplementation with placebo drops identical to those containing L. reuteri once daily for 21 consecutive days
Crying and fussing time
Change in daily crying and fussing time measured by Baby Day Diary
Time frame: From baseline to Day 7
Crying and fussing time
Change in mean daily crying and fussing time measured by Baby Day Diary
Time frame: From baseline to Day 3, Day 5, Day 14, Day 21
Crying time
Change in mean daily crying time measured by Baby Day Diary
Time frame: From baseline to Day 3, Day 5, Day 7, Day 14, Day 21
Number of responders
Proportion of responders defined as reduction of daily average crying time with 50 % compared to baseline
Time frame: From baseline to Day 3, Day 5, Day 7, Day 14, Day 21
Family quality of life (family QoL)
Change in family QoL measured by the PedsQL Family Impact Module (Acute) - Total Score
Time frame: From baseline to Day 7 and Day 21
Sleeping time
Change in mean sleeping time measured by Baby Day Diary
Time frame: From baseline to Day 3, Day 5, Day 7, Day 14, Day 21
Maternal depression
Change in maternal depression measured by the Edinburgh Postnatal Depression Scale Total Score
Time frame: From baseline to Day 7 and Day 21
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