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Hypnotherapy for IBD patients with IBS-like symptoms.


- candidate number12318
- NTR NumberNTR3414
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mei-2012
- Secondary IDsNL39964.018.12 CCMO
- Public TitleHypnotherapy for IBD patients with IBS-like symptoms.
- Scientific TitleHypnotherapy for adolescents and adults with Inflammatory bowel disease and symptoms compatible with Irritable bowel syndrome: A randomized controlled trial.
- ACRONYMHIPI
- hypothesisGut-directed hypnotherapy leads to a substantial reduction in IBS-like symptoms in patients with IBD.
- Healt Condition(s) or Problem(s) studiedIrritable bowel syndrome, Inflammatory bowel disease
- Inclusion criteriaPatients 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 criteriaExclusion 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2012
- planned closingdate1-sep-2013
- Target number of participants80
- InterventionsEither 6 sessions of gut-directed hypnotherapy, or 6 sessions of standard medical treatment with supportive therapy.
- Primary outcomeThe number of patients with >50% reduction in IBS-SSS pain score.
- Secondary outcomeSecondary 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.
- TimepointsPrimary outcome: At 6 months follow-up.
- Trial web sitehttp://www.hypnosebijbuikpijn.nl/
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. Marc A. Benninga
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Marc A. Benninga
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryBACKGROUND:
30-50% of patients with inflammatory bowel disease (IBD) in remission have irritable bowel syndrome(IBS)-like symptoms for which treatment options are limited. Often these complaints result in additional health care use. Gut-directed hypnotherapy has been effective in the treatment of patients with IBS only.

AIM:
To study the effectiveness of gut-directed hypnotherapy in the treatment of IBS-like symptoms in patients with inflammatory bowel disease.

METHODS:
Patients (age >11 years) with IBD in remission and in addition IBS-like symptoms will be will be recruited in the Netherlands and randomly allocated to either 6 sessions of hypnotherapy or standard medical care and 6 sessions of supportive therapy. The primary outcome will be the number of patients with >50% reduction in the pain component of the IBS severity scoring system (IBS-SSS) score. Based on results in studies on the effectiveness of hypnotherapy in IBS patients it is estimated that 75% of the patients will have a >50% reduction 6 months after treatment versus only 40% of the control group. With an estimated drop-out rate of 10%, 80 patients are needed to detect a 35% reduction with a statistical power of 80%, and a twosided alpha of 5%. 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 and 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, faecal protease activity and microbiota and the ability of patientís faecal supernatant to induce colonic hypersensitivity to distension in rats by colonic infusion.
- Main changes (audit trail)
- RECORD2-mei-2012 - 19-mei-2012


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