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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
J. Marc Rhoads, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01849991
First received: January 31, 2013
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Gastrointestinal
Colic
Biological: Lactobacillus reuteri
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 45 healthy infants with colic will receive LR (health-promoting bacteria) or placebo measuring any changes in their health status. [ Time Frame: 92 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Determine effect of L. reuteri in 45 infants with colic on gastrointestinal inflammation as assessed by fecal calprotectin. [ Time Frame: 1, 42 & 92 days ] [ Designated as safety issue: No ]
    To examine for evidence of anti-inflammatory effects in the normal intestine, we will test fecal samples from all infants for calprotectin level.


Other Outcome Measures:
  • Measuring the change in crying times (Barr Diary) in 45 healthy infants with colic during the administration of L reuteri. [ Time Frame: 92 days ] [ Designated as safety issue: No ]
    Clinical scoring of crying and fussing will be evaluated using the Barr diary which will show crying patterns.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    A stool sample will be collected and analyzed to determine the effect on overall microbiota produced by the ingestion of LR.


Estimated Enrollment: 70
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 is sunflower oil (vehicle for LR). The placebo will be administered the same as drug listed above.

Placebo Comparator: Sunflower Oil
The second arm includes 15 subjects on placebo (sunflower oil.)

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.

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Full-term babies with colic (21-70 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849991

Contacts
Contact: Nicole Y Fatheree, BBA 713-500-5669 nicole.fatheree@uth.tmc.edu

Locations
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    nicole.fatheree@uth.tmc.edu   
Principal Investigator: J. Marc Rhoads, M.D.         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: J. Marc Rhoads, M.D. The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: J. Marc Rhoads, Director, Pediatric Gastroentrologist, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01849991     History of Changes
Other Study ID Numbers: HSC-11-0203, HSC-MS-11-0203
Study First Received: January 31, 2013
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
Crying
Fussiness
Gas
Hydrogen Breath
Fecal Calprotectin

Additional relevant MeSH terms:
Colic
Inflammation
Abdominal Pain
Pain
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 24, 2014