Clinical trial NCT00907790: Nursing Management of Irritable Bowel Syndrome (IBS) 2008
Official title: Nursing Management of IBS:Improving Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Cognitive Therapy
Abdominal Pain
Quality of Life
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2009-05-25
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Daily abdominal pain
timeFrame: Baseline, three and six months post randomization
measure: IBS Quality of Life Questionnaire
timeFrame: Baseline, three and six months post randomization
Secondary outcomes:
measure: Salivary cortisol
timeFrame: Baseline, three and six months post randomization
measure: Interleukin-10(IL-10) and Interleukin-12(IL-12)
timeFrame: Baseline, three and six months post randomization
measure: Fecal calprotectin
timeFrame: Baseline, three and six months post randomization
measure: Intestinal permeability (urine)
timeFrame: Baseline, three and six months post randomization
measure: Brief Symptom Inventory
timeFrame: Baseline, three and six months post randomization
measure: Cognitive Scale for Functional Bowel Disorders
timeFrame: Baseline three and six months post randomization
measure: Work Productivity & Activity Impairment
timeFrame: Baseline, three and six months post rand
measure: Daily symptoms(other GI and psychological)
timeFrame: Baseline, three and six months post randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Maargaret M Heitkemper, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang PL, Burr RL, Buchanan DT, Pike KC, Kamp KJ, Heitkemper MM. Indirect effect of sleep on abdominal pain through daytime dysfunction in adults with irritable bowel syndrome. J Clin Sleep Med. 2020 Oct 15;16(10):1701-1710. doi: 10.5664/jcsm.8658.
citation: Kamp KJ, Weaver KR, Sherwin LB, Barney P, Hwang SK, Yang PL, Burr RL, Cain KC, Heitkemper MM. Effects of a comprehensive self-management intervention on extraintestinal symptoms among patients with IBS. J Psychosom Res. 2019 Nov;126:109821. doi: 10.1016/j.jpsychores.2019.109821. Epub 2019 Aug 29.
citation: Han CJ, Kohen R, Jun S, Jarrett ME, Cain KC, Burr R, Heitkemper MM. COMT Val158Met Polymorphism and Symptom Improvement Following a Cognitively Focused Intervention for Irritable Bowel Syndrome. Nurs Res. 2017 Mar/Apr;66(2):75-84. doi: 10.1097/NNR.0000000000000199.