Irritable Bowel Syndrome Evaluation and Treatment in Primary Care

This study has been completed.
Sponsor:
Collaborator:
Genova Diagnostics
Information provided by (Responsible Party):
American Academy of Family Physicians
ClinicalTrials.gov Identifier:
NCT01641341
First received: May 9, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Bifidobacterium infantis
Drug: Pancrelipase
Drug: Nitazoxanide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Irritable Bowel Syndrome Evaluation and Treatment in Primary Care

Resource links provided by NLM:


Further study details as provided by American Academy of Family Physicians:

Primary Outcome Measures:
  • A reduction in IBS symptoms [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 61
Study Start Date: November 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo capsule
Placebo capsule (sugar pill with no active medication)
Drug: Placebo
Placebo capsule will not contain active treatment ingredients.
Other Name: Sugar pill
Active Comparator: 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
Drug: Bifidobacterium infantis
once a day for seven to eight weeks
Other Names:
  • B. Bifidum
  • B. Breve
  • B. Infantis
  • Bifidobacterias
  • Bifidobacterium bifidum
  • Bifidum
  • Bifidus
  • Probiotic
Drug: Pancrelipase
Pancrelipase (one capsule prior to meals or snacks)
Other Name: Lipancreatin
Drug: Nitazoxanide
Nitazoxanide (500mg twice a day for 7 days)
Other Name: Alinia

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01641341

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

No publications provided

Responsible Party: American Academy of Family Physicians
ClinicalTrials.gov Identifier: NCT01641341     History of Changes
Other Study ID Numbers: 10-108
Study First Received: May 9, 2011
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by American Academy of Family Physicians:
Irritable Bowel Syndrome
Genova Diagnostics kit
Stool test
Rome III
Practice-based research
treatable parasite
Pancreatic insufficiency
Bowel dysbiosis
High levels of inflammation, C. difficile, or H. pylori

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pancrelipase
Pancreatin
Nitazoxanide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antiparasitic Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 23, 2014