Skip to main content
OpenTrials
Completed

NCT Number: NCT00907790

Nursing Management of Irritable Bowel Syndrome (IBS) 2008

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care (Control Group)

Behavioral

Comprehensive Self-Management (CSM)

Behavioral

Comprehensive Self-Management includes 8 sessions that cover education, diet, relaxation training, and cognitive behavioral strategies as they related to symptoms of IBS

Primary outcomes

  1. Daily abdominal pain

    Time frame: Baseline, three and six months post randomization

  2. IBS Quality of Life Questionnaire

    Time frame: Baseline, three and six months post randomization

Secondary outcomes

  1. Salivary cortisol

    Time frame: Baseline, three and six months post randomization

  2. Interleukin-10(IL-10) and Interleukin-12(IL-12)

    Time frame: Baseline, three and six months post randomization

  3. Fecal calprotectin

    Time frame: Baseline, three and six months post randomization

  4. Intestinal permeability (urine)

    Time frame: Baseline, three and six months post randomization

  5. Brief Symptom Inventory

    Time frame: Baseline, three and six months post randomization

  6. Cognitive Scale for Functional Bowel Disorders

    Time frame: Baseline three and six months post randomization

  7. Work Productivity & Activity Impairment

    Time frame: Baseline, three and six months post rand

  8. Daily symptoms(other GI and psychological)

    Time frame: Baseline, three and six months post randomization

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Nursing Management of IBS:Improving Outcomes

Important dates

Study start
2009
Primary completion
2012
Study completion
2013
First posted
May 25, 2009
Registry last updated
May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.