drugset / Trial / NCT01541046
Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic
RandomizedParallel-groupTriple-blindTreatment
Summary
Infantile colic is a common medical condition which remains a frustrating problem for parents and health care providers with no clear treatment guidelines. To fill the void in existing literature, we present a protocol to examine whether probiotics are effective in decreasing infantile colic symptoms when compared to placebo treatment. We hypothesize that oral administration of the probiotic L. reuteri DSM 17938 will reduce symptoms of infantile colic in breastfed infants in comparison to placebo. An interim analysis will be conducted after 50 infants randomized to monitor both safety and efficacy.
Timeline
- Start
- 2011-11
- Primary completion
- 2014-06
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lactobacillus reuteri DSM 17938 | Other / unclassified | 1e+08 unknown | Oral |
Indications
No indication recorded.