Irritable Bowel Syndrome Evaluation and Treatment in Primary Care

NCT ID: NCT01641341

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-03-31

Brief 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.

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo capsule

Placebo capsule (sugar pill with no active medication)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo capsule will not contain active treatment ingredients.

Active treatment

Active treatment will consist of the following interventions:

1. Bowel Dysbiosis - probiotics Bifidobacterium infantis,

2. Maldigestion/Malabsorption - Pancrelipase

3. Parasitic infection/presence - Nitazoxanide

Group Type: ACTIVE_COMPARATOR

Bifidobacterium infantis

Intervention Type: DRUG

once a day for seven to eight weeks

Pancrelipase

Intervention Type: DRUG

Pancrelipase (one capsule prior to meals or snacks)

Nitazoxanide

Intervention Type: DRUG

Nitazoxanide (500mg twice a day for 7 days)

Interventions

Bifidobacterium infantis

once a day for seven to eight weeks

Intervention Type: DRUG

Pancrelipase

Pancrelipase (one capsule prior to meals or snacks)

Intervention Type: DRUG

Nitazoxanide

Nitazoxanide (500mg twice a day for 7 days)

Intervention Type: DRUG

Placebo

Placebo capsule will not contain active treatment ingredients.

Intervention Type: DRUG

Other Intervention Names

B. Bifidum; B. Breve; B. Infantis; Bifidobacterias; Bifidobacterium bifidum; Bifidum; Bifidus; Probiotic; Lipancreatin; Alinia; Sugar pill

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genova Diagnostics

INDUSTRY

Sponsor Role: collaborator

American Academy of Family Physicians

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evelyn Lewis & Clark, MD, MA

Role: PRINCIPAL_INVESTIGATOR

National Research Network

Wilson Pace, MD

Role: STUDY_CHAIR

National Research Network

Gerard Mullin, MD

Role: STUDY_CHAIR

Johns Hopkins School of Medicine

Locations

Torrance Clinical Research

Lomita, California, United States

Overland Park Family Health Partners

Leawood, Kansas, United States

American Academy of Family Physicians-National Research Network

Leawood, Kansas, United States

Baton Rouge Family Practice

Baton Rouge, Louisiana, United States

Family Medicine of SE Missouri

Sikeston, Missouri, United States

Missouri Delta Physician Services

Sikeston, Missouri, United States

Silver Sage Center for Family Medicine

Reno, Nevada, United States

Raj Kachoria

Macedon, New York, United States

Southwest Family Medicine Associates

Dallas, Texas, United States

Countries

United States

Other Identifiers

10-108

Identifier Type: -

Identifier Source: org_study_id