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

January 26, 2018 updated by: J. Marc Rhoads, The University of Texas Health Science Center, Houston
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 weeks to 3 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.)
Biological: Placebo
Placebo is sunflower oil (vehicle for LR). The placebo will be administered the same way as drug listed above.

What is the study measuring?

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.
Time Frame: 92 days
  1. Physical Examination of infants will be performed to evaluate any adverse effects of LR.
  2. 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.
Time Frame: 1, 42 & 92 days
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measuring the change in crying times (Barr Diary) in 45 healthy infants with colic during the administration of L reuteri.
Time Frame: 92 days
Clinical scoring of crying and fussing will be evaluated using the Barr diary which will show crying patterns.
92 days
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: 1& 42 days
  1. A panel of inflammatory biomarkers will be examined which includes Th1 cytokines (TNFα, IL-1β); a Th2 cytokine (IL-10), a cytokine which regulates maturation of Tregs (IL-2), a cytokine receptor (OPG), a marker of intestinal barrier function (TIMP-1) and a marker for autoimmunity (TWEAK). Biomarkers will be assessed by MSD human multiplex cytokine assays or R&D Human ELISA kit.
  2. We will determine if LR treatment affects the frequency of Tregs in PBMCs in normal babies with colic.
1& 42 days
Determine effect of L. reuteri on gastrointestinal inflammation as assessed by fecal microbiota in 45 healthy infants with colic.
Time Frame: 1, 42 & 92 days
A stool sample will be collected and analyzed to determine the effect on overall microbiota produced by the ingestion of LR.
1, 42 & 92 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: J. Marc Rhoads, M.D., The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

May 6, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Actual)

January 30, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-11-0203
  • HSC-MS-11-0203 (Other Identifier: University of Texas Health Science Center at Houston)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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