Irritable Bowel Syndrome Evaluation and Treatment in Primary Care
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Bifidobacterium infantis; Pancrelipase; Nitazoxanide; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): once a day for seven to eight weeks; Pancrelipase (one capsule prior to meals or snacks); Nitazoxanide (500mg twice a day for 7 days); Placebo capsule will not contain active treatment ingredients.
Other intervention name(s): B. Bifidum; B. Breve; B. Infantis; Bifidobacterias; Bifidobacterium bifidum; Bifidum; Bifidus; Probiotic; Lipancreatin; Alinia; Sugar pill
Intervention MeSH terms: Nitazoxanide; Pancrelipase; Pancreatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: 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