Hypnotherapy for IBD patients with IBS-like symptoms.
- Conditions
- Inflammatory bowel diseaseInflammatoire darmziekteIrritable bowel syndromePrikkelbare darmsyndroom
- Registration Number
- NL-OMON22531
- Lead Sponsor
- Academic Medical Center (AMC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 80
Patients with inflammatory bowel disease and IBS-like symptoms, age >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 and no disease activity on imaging studies of the intestine. 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 are a concomitant organic gastrointestinal disease, stenotic IBD, complicated IBD that had required surgery more than once, another coexisiting 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 The number of patients with >50% reduction in IBS-SSS pain score.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are the effects of therapy on total IBS-SSS score, adequate relief, health related quality of life, IBD disease activity, health utility index, depression, anxiety, somatisation, abdominal pain related cognitions, absence of school or work, use of health care resources and additional costs, use of IBD medication, colonic sensitivity to distension, fecal protease activitiy and microbiota and the ability of patient's fecal supernatant to induce colonic hypersensitivity to distension in rats by colonic infusion.