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Pilot Study Studying Physiological Effects of Probiotic Pills in Patients With Abdominal Pain/Discomfort and Bloating

NCT01064661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2013-12-12

No results posted yet for this study

Summary

We are conducting a study to learn if probiotics, which are live bacteria found in food like yogurt and cheese, will improve symptoms of abdominal pain. Individuals participating in this study will take probiotic pills to see if this affects the expression of certain pain receptors in the intestines that relate to pain sensation. Biopsies will be taken from the colon before subjects take the probiotic pills. Subjects will then be given one of two different types of probiotic pills to take for 3-4 weeks. After taking the supplements, more biopsies will be collected to see if any changes have taken places. This study requires one screening visit and two clinic visits to UNC hospital. Subjects will also complete daily diary cards for 2 weeks during the study to record their symptoms and also collect 2 stool samples.

Conditions

Interventions

DIETARY_SUPPLEMENT

Single probiotic arm of L-NCFM alone

Single probiotic of L-NCFM alone pills BID (2x10\^10 cfu total bacteria per day)

DIETARY_SUPPLEMENT

Blend probiotic arm of L-NCFM and B-LBi07

Blend probiotic arm of L-NCFM and B-LBi07 pills BID (2x10\^10 cfu total bacteria per day)

Sponsors & Collaborators

  • Danisco

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Yehuda Ringel, MD · UNC Dept. Gastroenterology and Hepatology

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-02-29
Completion
2012-02-29

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01064661 on ClinicalTrials.gov