Full Text View
Tabular View
No Study Results Posted
Related Studies
Nursing Management of Irritable Bowel Syndrome (IBS) 2008
This study is currently recruiting participants.
Verified November 2010 by University of Washington

First Received on May 21, 2009.   Last Updated on November 4, 2010   History of Changes
Sponsor: University of Washington
Collaborator: National Institute of Nursing Research (NINR)
Information provided by: University of Washington
ClinicalTrials.gov Identifier: NCT00907790
  Purpose

The aim of this study is test the efficacy of a comprehensive self-management therapy to decrease abdominal pain/discomfort and improve quality of life in patients with irritable bowel syndrome (IBS) compared to IBS patients receiving their usual care.


Condition Intervention Phase
Irritable Bowel Syndrome
Behavioral: Usual Care
Behavioral: Comprehensive Self-Management
Phase II
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nursing Management of IBS:Improving Outcomes

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Daily abdominal pain [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]
  • IBS Quality of Life Questionnaire [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Salivary cortisol [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]
  • IL-10 and IL-12 [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]
  • Fecal calprotectin [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]
  • Intestinal permeability (urine) [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]
  • Brief Symptom Inventory [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]
  • Cognitive Scale for Functional Bowel Disorders [ Time Frame: Baseline three and six months post randomization ] [ Designated as safety issue: No ]
  • Work Productivity & Activity Impairment [ Time Frame: Baseline, three and six months post rand ] [ Designated as safety issue: No ]
  • Daily symptoms(other GI and psychological) [ Time Frame: Baseline, three and six months post randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CSM Behavioral: Comprehensive Self-Management
Comprehensive Self-Management includes 8 sessions that cover education, diet, relaxation training, and cognitive behavioral strategies as they related to symptoms of IBS
No Intervention: Usual Care Behavioral: Usual Care
Includes the usual care provided by the person and their health care provider.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women must be: 18-70 years old, have had symptoms of Irritable Bowel Syndrome (IBS) at least 6 mo prior to their diagnosis, and have had their diagnosis for at least 6 months, and the diagnosis had to be made by a health care provider (e.g., internist, gastroenterologist, family, nurse practitioner, physician assistant).
  • In addition, the subjects must be experiencing IBS symptoms as described in the Rome-III criteria.161 That is recurrent abdominal pain or discomfort at least 3 days a mo in the last 3 mo associated with 2 or more of the following: improvement with defecation, onset associated with a change in frequency or form (appearance) of their stool.
  • Adults 50 or older must have a negative colonoscopy, sigmoidoscopy, abdominal ultrasonography, or barium enema.
  • Anyone with a "red flag" symptom (e.g., lost 10 lbs without trying, blood in stool, anemia) will be contacted for additional clarification.

Exclusion Criteria:

  • Participants will be excluded if they are taking the following medications: antibiotics, daily use of anticholinergics, tricyclic antidepressants, calcium-channel blockers
  • Have a medical history of abdominal surgery (except appendectomy, Caesarian section, tubal ligation, laparoscopic cholecystectomy, hysterectomy, or abdominal wall hernia repair)
  • Active organic GI disease, gluten intolerance (celiac disease), or chronic moderate to severe pain condition (e.g., low back pain, fibromyalgia)
  • Recent travel to regions with endemic parasitic diseases
  • Current mental health disorders (psychosis, bipolar disorder, current moderate to severe depressive episode, suicide attempt, drug or alcohol abuse or dependence within 2yrs)
  • Cardiac valvular disease, immune compromised immunologic disorders (e.g., autoimmune conditions)
  • Women who are pregnant, breast feeding, or planning to get pregnant in the next year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907790

Contacts
Contact: Monica E Jarrett, PhD 206-543-2348 jarrett@u.washington.edu
Contact: Anne Poppe, PhC 206-616-9955 apoppe@u.washington.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Monica E Jarrett, PhD     206-543-2348     jarrett@u.washington.edu    
Contact: Anne Poppe, PhC     206-616-9955     apoppe@u.washington.edu    
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Maargaret M Heitkemper, PhD University of Washington
  More Information

No publications provided

Responsible Party: Margaret Heitkemper, University of Washington
ClinicalTrials.gov Identifier: NCT00907790     History of Changes
Other Study ID Numbers: 32722-G, 2R01NR004142
Study First Received: May 21, 2009
Last Updated: November 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Irritable Bowel Syndrome
Cognitive Therapy
Abdominal Pain
Quality of Life

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on February 09, 2012