Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic

Conditions
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Gastrointestinal, Colic

Intervention / Treatment
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* Biological: Lactobacillus reuteri
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full-term babies with colic (21-90 days old, who cry/fuss > 3h daily x > 3d wk) baby must have more than 3h crying for enrollment Exclusion Criteria: severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk > 8 times daily, projectile, bilious or bloody emesis) failure to thrive intrauterine growth retardation hematochezia (blood in the stools) diarrhea (watery stools that takes the shape of a container > 5x daily) fever (38.2 degrees) Premature infants (<37 wk gestation)

Ages Eligible for Study
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Minimum Age: 3 Weeks
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lactobacillus reuteri<br>The first arm of the cohort will include 30 patients on LR (5x10^8 cfu's orally once daily.) | Biological: Lactobacillus reuteri<br>* 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.<br>|
| Placebo Comparator: Sunflower Oil<br>The second arm includes 15 subjects on placebo (sunflower oil.) | Biological: Placebo<br>* Placebo is sunflower oil (vehicle for LR). The placebo will be administered the same way as drug listed above.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 45 healthy infants with colic will receive LR (health-promoting bacteria) or placebo measuring any changes in their health status. | Physical Examination of infants will be performed to evaluate any adverse effects of LR. Electrolyte testing at baseline will evaluate for any inborn error of fluid and electrolyte balance and at end of treatment will evaluate for any adverse impact of LR in the subjects. | 92 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine effect of L. reuteri in 45 infants with colic on gastrointestinal inflammation as assessed by fecal calprotectin. | To examine for evidence of anti-inflammatory effects in the normal intestine, we will test fecal samples from all infants for calprotectin level. | 1, 42 & 92 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crying, Fussiness, Gas, Hydrogen Breath, Fecal Calprotectin