Irritable Bowel Syndrome Evaluation and Treatment in Primary Care

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Bifidobacterium infantis; Drug: Pancrelipase; Drug: Nitazoxanide

Detailed Description

This study will take place in 8 practices which are members of the AAFP NRN. Eligible practices must be able to identify at least 25 active patients (seen in last 24 months) with a diagnosis of IBS from billing or electronic health record data to be eligible to participate. Each practice will be asked to recruit 10 patients.

Adult patients identified by their physician as having IBS symptoms will be termed "potentially eligible patients" and will be invited into the study via personal invitation when presenting at the practice on a regularly-scheduled visit, by letters mailed to these patients on practice letterhead and signed by the physician, or through phone contact with a member of the practice.

If a patient agrees to participate in the study, s/he will be asked to read and sign an initial informed consent. Consent forms will be included with the letters mailed to patients, and additional copies of the consent will be kept at the practice. The initial informed consent will cover consent for stool testing, for collection of all study outcome data including new diagnoses uncovered by the stool testing and any follow up procedures that are conducted as a result of the stool test results. This initial consent will indicate that based on stool testing results the patient may be referred for more evaluation or open label treatment from their physician or may be recommended for one or more study directed treatment(s).

Once the stool tests have returned the patient will be contacted to review these results. At that time the patient will be asked to sign a secondary consent form if study directed therapy is recommended. This consent form or these consent forms (if more than one therapy is recommended) will be treatment specific and explain that the patient will be randomized to active or placebo treatment in a double blinded fashion, that the patient will be crossed over to either active treatment or placebo after 8 weeks and that all patients will be offered active treatment by the end of the study.

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Lomita, California, United States, 90717
      • Torrance Clinical Research
  • Kansas
    • Leawood, Kansas, United States, 66209
      • Overland Park Family Health Partners
    • Leawood, Kansas, United States, 66211
      • American Academy of Family Physicians-National Research Network
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70806
      • Baton Rouge Family Practice
  • Missouri
    • Sikeston, Missouri, United States, 63801
      • Family Medicine of SE Missouri
    • Sikeston, Missouri, United States, 63801
      • Missouri Delta Physician Services
  • Nevada
    • Reno, Nevada, United States, 89521
      • Silver Sage Center for Family Medicine
  • New York
    • Macedon, New York, United States, 14502
      • Raj Kachoria
  • Texas
    • Dallas, Texas, United States, 75235
      • Southwest Family Medicine Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• between the ages of 18 and 65 years of age
• meet Rome III criteria for IBS
• willing to complete surveys and daily symptom logs for three to four 14-day periods
• have positive symptoms for at least 3 days out of the 14 days of the baseline daily log records

Exclusion Criteria:

• have HIV or AIDs
• have gall stones with a gall bladder present

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo capsule; Placebo capsule (sugar pill with no active medication)	Drug: Placebo; Placebo capsule will not contain active treatment ingredients.; Other Names: Sugar pill
Active Comparator: Active treatment; Active treatment will consist of the following interventions: Bowel Dysbiosis - probiotics Bifidobacterium infantis,; Maldigestion/Malabsorption - Pancrelipase; Parasitic infection/presence - Nitazoxanide	Drug: Bifidobacterium infantis; once a day for seven to eight weeks; Other Names: Probiotic; Bifidobacterium bifidum; B. Bifidum; B. Breve; B. Infantis; Bifidobacterias; Bifidum; Bifidus; Drug: Pancrelipase; Pancrelipase (one capsule prior to meals or snacks); Other Names: Lipancreatin; Drug: Nitazoxanide; Nitazoxanide (500mg twice a day for 7 days); Other Names: Alinia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A reduction in IBS symptoms	20 to 40% of the control/placebo patients and approximately 70-75% of the treatment patients will experience a positive outcome as determined by both the daily log sheets and the modified Rome criteria administered at baseline, 8 and 16 weeks.	16 weeks

Collaborators and Investigators

• Sponsor: American Academy of Family Physicians
• Collaborators: Genova Diagnostics
• Investigators: Principal Investigator: Evelyn Lewis & Clark, MD, MA, National Research Network; Study Chair: Wilson Pace, MD, National Research Network; Study Chair: Gerard Mullin, MD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: May 9, 2011
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (Estimate): July 16, 2012

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Pancreatic insufficiency; Genova Diagnostics kit; Stool test; Rome III; Practice-based research; treatable parasite; Bowel dysbiosis; High levels of inflammation, C. difficile, or H. pylori
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Anti-Infective Agents; Gastrointestinal Agents; Antiparasitic Agents; Pancrelipase; Nitazoxanide; Pancreatin
• Other Study ID Numbers: 10-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No