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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-04-30

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.

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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.

Conditions

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Gastrointestinal Colic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lactobacillus reuteri

The first arm of the cohort will include 30 patients on LR (5x10\^8 cfu's orally once daily.)

Group Type ACTIVE_COMPARATOR

Lactobacillus reuteri

Intervention Type BIOLOGICAL

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.

Sunflower Oil

The second arm includes 15 subjects on placebo (sunflower oil.)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Placebo is sunflower oil (vehicle for LR). The placebo will be administered the same way as drug listed above.

Interventions

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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.

Intervention Type BIOLOGICAL

Placebo

Placebo is sunflower oil (vehicle for LR). The placebo will be administered the same way as drug listed above.

Intervention Type BIOLOGICAL

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)

Minimum Eligible Age

3 Weeks

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes