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Irritable Bowel Syndrome Evaluation and Treatment in Primary Care

NCT01641341 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2019-01-23

No results posted yet for this study

Summary

Overview of Methods: This is a double blind, randomized controlled trial with a non-balanced randomization and a cross-over to active treatment for placebo treated individuals who do not respond to the placebo treatment. Data collected will help determine the feasibility of the study design in primary care offices. Patient outcome data will provide a more precise estimate of power for a larger, classic randomized trial to determine if such a study can be reasonably undertaken within primary care practices.

Aims: The aims of this pilot study are to: 1) Evaluate how well Genova Diagnostics (GDx) IBS tests can be integrated into primary care, 2) examine the effects of the Genova Diagnostics (GDx) test on treatment, and 3) observe and track patients' health, quality of life and clinical outcomes related to IBS during the study period.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Bifidobacterium infantis

once a day for seven to eight weeks

DRUG

Pancrelipase

Pancrelipase (one capsule prior to meals or snacks)

DRUG

Nitazoxanide

Nitazoxanide (500mg twice a day for 7 days)

DRUG

Placebo

Placebo capsule will not contain active treatment ingredients.

Sponsors & Collaborators

  • Genova Diagnostics

    collaborator INDUSTRY

  • American Academy of Family Physicians

    lead OTHER

Principal Investigators

  • Evelyn Lewis & Clark, MD, MA · National Research Network

  • Wilson Pace, MD · National Research Network

  • Gerard Mullin, MD · Johns Hopkins School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01641341 on ClinicalTrials.gov