Nursing Management of Irritable Bowel Syndrome (IBS) 2008

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
Usual Care (Control Group)	Usual Care (Control Group)	Includes the usual care provided by the person and their health care provider.
Comprehensive Self-Management (CSM)	Comprehensive Self-Management (CSM)	Comprehensive Self-Management includes 8 sessions that cover education, diet, relaxation training, and cognitive behavioral strategies as they related to symptoms of IBS --------------------------------------------------------------------------------

Primary Outcome Measures

Name	Time	Method
Daily abdominal pain	Baseline, three and six months post randomization
IBS Quality of Life Questionnaire	Baseline, three and six months post randomization

Secondary Outcome Measures

Name	Time	Method
Salivary cortisol	Baseline, three and six months post randomization
Interleukin-10(IL-10) and Interleukin-12(IL-12)	Baseline, three and six months post randomization
Fecal calprotectin	Baseline, three and six months post randomization
Intestinal permeability (urine)	Baseline, three and six months post randomization
Brief Symptom Inventory	Baseline, three and six months post randomization
Cognitive Scale for Functional Bowel Disorders	Baseline three and six months post randomization
Work Productivity & Activity Impairment	Baseline, three and six months post rand
Daily symptoms(other GI and psychological)	Baseline, three and six months post randomization

Recruitment & Eligibility