NCT05512234

Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With Colic

A Double-blind, Mylti-center, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: BioGaia AB · Industry
• Sex: All
• Age: 3 Weeks – 8 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Colic, Infantile

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L. reuteri	Dietary supplementation with drops containing L. reuteri once daily for 21 consecutive days
DIETARY_SUPPLEMENT	Placebo	Dietary supplementation with placebo drops identical to those containing L. reuteri once daily for 21 consecutive days

Timeline

• Start date: 2022-07-13
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2022-08-23
• Last updated: 2025-09-22

Locations

2 sites across 2 countries: Ireland, Sweden