Nursing Management of Irritable Bowel Syndrome (IBS) 2008

Irritable Bowel Syndrome Clinical Trial

Official title:

Nursing Management of IBS:Improving Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907790
• Other study ID #: 32722
• Secondary ID: 2R01NR004142
• Status: Completed
• Phase: N/A
• First received: May 21, 2009
• Last updated: May 1, 2017
• Start date: March 2009
• Est. completion date: January 2013

Study information

• Verified date: May 2017
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Behavioral:
• Usual Care (Control Group)

• 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

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily abdominal pain		Baseline, three and six months post randomization
Primary	IBS Quality of Life Questionnaire		Baseline, three and six months post randomization
Secondary	Salivary cortisol		Baseline, three and six months post randomization
Secondary	Interleukin-10(IL-10) and Interleukin-12(IL-12)		Baseline, three and six months post randomization
Secondary	Fecal calprotectin		Baseline, three and six months post randomization
Secondary	Intestinal permeability (urine)		Baseline, three and six months post randomization
Secondary	Brief Symptom Inventory		Baseline, three and six months post randomization
Secondary	Cognitive Scale for Functional Bowel Disorders		Baseline three and six months post randomization
Secondary	Work Productivity & Activity Impairment		Baseline, three and six months post rand
Secondary	Daily symptoms(other GI and psychological)		Baseline, three and six months post randomization