Hypnotherapy for IBD patients with IBS-like symptoms.

Hypnotherapy for adolescents and adults with Inflammatory bowel disease and symptoms compatible with Irritable bowel syndrome: A randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22531

Enrollment

Registered

2012-05-02

Start date

2012-03-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease Inflammatoire darmziekte Irritable bowel syndrome Prikkelbare darmsyndroom

Interventions

Either 6 sessions of gut-directed hypnotherapy, or 6 sessions of standard medical treatment with supportive therapy.

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
The number of patients with >50% reduction in IBS-SSS pain score.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactMarc A. Benninga

Kinderarts MDL, AMC, H7-248 P.O. Box 22660

m.a.benninga@amc.nl+31 (0)20 5663053 / +31 (0)20 5666297

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)