Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic|
- 45 healthy infants with colic will receive LR (health-promoting bacteria) measuring any changes in their health status. [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
- Determine effect of L. reuteri in 45 infants with colic on gastrointestinal inflammation as assessed by fecal calprotectin. [ Time Frame: 176 ] [ Designated as safety issue: No ]
- Measuring the change in crying times (Barr Diary) in 45 healthy infants with colic during the administration of L reuteri. [ Time Frame: 176 ] [ Designated as safety issue: No ]
- Determine effects of L. reuteri in 45 healthy infants with colic measuring the immunologic responses with plasma cytokines and circulating regulatory T-cells. [ Time Frame: 42 days ] [ Designated as safety issue: No ]
- Determine effect of L. reuteri on gastrointestinal inflammation as assessed by fecal microbiota in 45 healthy infants with colic. [ Time Frame: 176 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Lactobacillus reuteri
The first arm of the cohort will include 30 patients on LR (5x10^8 cfu's orally once daily.)
Biological: Lactobacillus reuteri
Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment of a well-functioning gastrointestinal (GI) microbiota and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment.
The drug is a clear liquid when suspended in sunflower oil. The drug will be administered orally, 0.2cc once daily.
Placebo Comparator: Sunflower Oil
The second arm includes 15 subjects on placebo (sunflower oil.)
This study will evaluate the safety and tolerability of Lactobacillus reuteri in healthy infants with colic. Patients will be randomized to receive either L. reuteri at one dose orally for a total of 42 doses. The doses will be 5x108 (5 drops) during a satisfactory assessment of safety and tolerability. The time on study treatment is 6 months, and the target sample size is 45 healthy infants.
Secondly, the investigators aim to gather evidence supporting hypothesis of safety and tolerability of Lactobacillus reuteri by administering a physical examination and testing of complete blood count, liver tests, and serum electrolytes over a forty-two day period.
|Contact: Nicole Y Fatheree, BBAemail@example.com|
|United States, Texas|
|University of Texas Health Science Center at Houston||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Nicole Y Fatheree, BBA 713-500-5669 firstname.lastname@example.org|
|Principal Investigator: J. Marc Rhoads, M.D.|
|Principal Investigator:||J. Marc Rhoads, M.D.||The University of Texas Health Science Center, Houston|