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Patient Attributes for Optimal Treatment Outcome in Irritable Bowel Syndrome. (IBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01297556
Recruitment Status : Unknown
Verified February 2011 by Michigan Gastroenterology Institute.
Recruitment status was:  Not yet recruiting
First Posted : February 16, 2011
Last Update Posted : February 16, 2011
Information provided by:
Michigan Gastroenterology Institute

Brief Summary:
The purpose of this study is to determine if any specific patient characteristics lead to improved outcome of IBS treatment, when conventional treatment as well as Cognitive Behavioral Therapy is used in combination.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Behavioral: Cognitive Behavior Therapy(CBT) Not Applicable

Detailed Description:
Although research has demonstrated the efficacy of various psychological and pharmacological treatments for irritable bowel syndrome (IBS)1, health professionals have limited information about how to determine which specific treatment regimens lead to optimal outcomes for specific IBS populations 2,3. A prevalent syndrome, with high healthcare costs, IBS is a debilitating chronic functional bowel disorder with increasingly interconnected psychosocial and gastrointestinal afflictions4. In general, IBS sufferers have not been found to respond consistently to a single medication or class of medications5. In the wake of the failures of medical therapies, many psychological interventions, adjunct to standard IBS treatments, have been examined1,6 such as Blanchard and Scharff's 2002 review of 12 random controlled trials that found strong evidence for the utility of hypnotherapy, cognitive behavioral therapy (CBT), and brief psychodynamic psychotherapy in helping to alleviate IBS symptoms7. Similarly, in a more recent study involving a meta-analysis of seventeen studies, with randomized trials comparing classes of psychological interventions, found that these psychological treatments also play a role in improving quality of life of IBS suffers1. Among these psychological interventions, cognitive behavioral therapy (CBT), a prescriptive therapy that specifically targets faulty thinking patterns, has been found to be quite effective in many empirical investigations. Recent evaluations of CBT interventions have found the therapy to have a direct effect on global improvements of IBS symptoms and quality of life8. Despite its demonstrated effectiveness, however, CBT does not work for all patients3,6,8. The successes of medical therapy alone compared to a treatment regimen combining psychological and pharmaceutical interventions have been greeted with mixed results- leading to the unnecessary waste of health resources in the course of treatment3,6. To decrease medical costs, as well to foster optimal treatment for IBS patients, there is a need for a better method of identifying which patients will most benefit from specific treatment options s (i.e. conventional medical treatment versus standard treatment and CBT)2,3.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Examining Patient Attributes To Determine Optimal Treatment Outcome in Irritable Bowel Syndrome.
Study Start Date : April 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Arm Intervention/treatment
No Intervention: Control group
Patients in this group will receive conventional treatment for IBS, including anti-diarrhea agents, laxatives, bulking agents and anti-spasmodic.
Experimental: Treatment
Patients in this group will receive conventional treatment for IBS, but in addition will receive 6 weeks of CBT
Behavioral: Cognitive Behavior Therapy(CBT)
Cognitive Behavior Therapy(CBT) for 6 weeks.

Primary Outcome Measures :
  1. IBS Quality of Life Inventory(IBS QOLF) [ Time Frame: 6 months ]
    Significant improvement in IBS QOLF score in the treatment group

Secondary Outcome Measures :
  1. Behavioral Symptom Inventory [ Time Frame: 6 months ]
    improvement in emotional function

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All newly diagnosed IBS patients using Rome III criteria above the age of 18.

Exclusion Criteria:

  • Patients with non-functional GI disorders, severe psychiatric disorders, including psychotic disorders, actively suicidal or alcoholism/other drug dependencies.
  • Pregnant women and minors(under age 18) will also be excluded.
  • Prisoners will also be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01297556

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Contact: Iftiker Ahmad, M.D. 517.332.1200 ext 221
Contact: Priscilla Wade, Ph.D 517.336.7366

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United States, Michigan
Michigan Gastroenterology Institute
East Lansing, Michigan, United States, 48823
Contact: Iftiker Ahmad, M.D.    517-332-1200 ext 221      
Principal Investigator: Iftiker Ahmad, M.D.         
Sponsors and Collaborators
Michigan Gastroenterology Institute
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Principal Investigator: Iftiker Ahmad, M.D. Michigan Gastroenterology Institute
1. Lackner JM, Mesmer C, Morley S, Dowzer C, Hamilton S. Psychological Lackner JM, Mesmer C, Morley S, Dowzer C, Hamilton S. Psychological Treatments for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis. J Consult Psychol. 2004;72(6):1100-1113. 2. Spiller R, Aziz Q, Creed F, et al. Guidelines on the irritable bowel syndrome: mechanisms and practical management. Gut. 2007;56(12):1770-98. 3. Zijdenbos IL, de Wit NJ, van der Heijden GJ, Rubin G, Quartero AO. Psychological treatments for the management of irritable bowel syndrome. Cochrane Database Syst Rev. 2009;(1):CD006442. 4. Jones R, Latinovic R, Charlton J, Gulliford M. Physical and psychological co-morbidity in irritable bowel syndrome: a matched cohort study using the General Practice Research Database. Aliment Pharmachol Ther. 2006;24(5):879-886. 5.Jailwala J, Imperiale TF, Kroenke K. Pharmacologic treatment of the irritable bowel syndrome: a systematic review of randomized, controlled trials. Ann Intern Med. 2000 Jul 18;133(2):136-47. Review. PMID: 10896640 6. 6. Spanier JA, Howden CW, Jones MP. A Systematic Review of Alternative Therapies in the Irritable Bowel Syndrome. Arch Intern Med. 2003;163(3):265-674. 7.Blanchard EB, Scharf L. Psychosocial aspects of assessment and treatment of irritable bowel syndrome in adults and recurrent abdominal pain in children. J Consult Psychol. 2002;70(3):725-738. 8. Lackner JM, Jaccard J, Krasner SS, Katz LA, Gudleski GD, Blanchard EB. How does cognitive behavior therapy for irritable bowel syndrome work? A mediational analysis of a randomized clinical trial. Gastroenterology. 2007 Aug;133(2):433-44. Epub 2007 May 21. PMID: 17681164

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Responsible Party: Iftiker Ahmad, M.D., Michigan Gastroenterology Institute Identifier: NCT01297556    
Other Study ID Numbers: MGI-IKA-IBS-2011
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: February 16, 2011
Last Verified: February 2011
Keywords provided by Michigan Gastroenterology Institute:
Irritable Bowel Syndrome
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases