Hypnotherapy for adolescents and adults with inflammatory bowel disease and symptoms compatible with irritable bowel syndrome.

Completed

Conditions: Crohn's disease
inflammatory bowel disease
ulcerative colitis
10017969

Registration Number: NL-OMON43963

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 85

Inclusion Criteria

Patients with inflammatory bowel disease and IBS-like symptoms, aged >11 years will be recruited. Patients have to be in remission of their inflammatory bowel disease as defined as no signs of inflammatory bowel disease, low inflammatory markers in laboratory tests, faecal calprotectin levels either below 50, or between 50-200 in combination with a recent (up to 6 months) normal colonoscopy. IBS-like symptoms are defined as abdominal pain for at least two months, fulfilling the pediatric or adult Rome-III criteria for IBS.

Exclusion Criteria

Exclusion criteria are a concomitant organic gastrointestinal disease, stenotic IBD, complicated IBD that had required surgery more than once, another coexisting complicated disease (e.g. malignancy, unstable cardiovascular, hepatic or renal disease), treatment by another health care professional for abdominal symptoms, mental retardation, insufficient knowledge of the Dutch language and previous hypnotherapy treatment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be the number of patients with >50% reduction in the<br /><br>pain component of the IBS severity scoring system (IBS-SSS) score.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are the effects of therapy on pain scores, adequate relief,<br /><br>health related quality of life, IBD disease activity, health utility index,<br /><br>depression, anxiety and somatisation, abdominal pain related cognitions,<br /><br>absence of school or work, use of health care resources and additional costs,<br /><br>use of IBD medication, colonic sensitivity to distension, cortisol level in<br /><br>hair, faecal protease activity and microbiota and the ability of patient*s<br /><br>faecal supernatant to induce colonic hypersensitivity to distension in rats by<br /><br>colonic infusion.</p><br>