drugset / Trial / NCT01849991
Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with colic. The study is being conducted in order to prove treatment dose with probiotic (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.
Timeline
- Start
- 2013-09
- Primary completion
- 2016-04
- Completion
- 2016-04
Publications
- Results Fatheree NY, Liu Y, Taylor CM, Hoang TK, Cai C, Rahbar MH, Hessabi M, Ferris M, McMurtry V, Wong C, Vu T, Dancsak T, Wang T, Gleason W, Bandla V, Navarro F, Tran DQ, Rhoads JM. Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. J Pediatr. 2017 Dec;191:170-178.e2. doi: 10.1016/j.jpeds.2017.07.036. Epub 2017 Sep 29.
- Rhoads JM, Collins J, Fatheree NY, Hashmi SS, Taylor CM, Luo M, Hoang TK, Gleason WA, Van Arsdall MR, Navarro F, Liu Y. Infant Colic Represents Gut Inflammation and Dysbiosis. J Pediatr. 2018 Dec;203:55-61.e3. doi: 10.1016/j.jpeds.2018.07.042. Epub 2018 Aug 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lactobacillus reuteri | Other / unclassified | 0.2 ml | Oral |
| Comparator | Lactobacillus reuteri | Other / unclassified | 5e+08 unknown | Oral |
Indications
No indication recorded.