NCT00706758

Brief Summary

In this randomized controlled study in patients with irritable bowel syndrome (IBS) we plan to compare the effects of a structured patient group education (IBS school) with receiving only written information in the form of a IBS-guidebook. The effects of the interventions on GI and psychological symptom severity, knowledge and quality of life will be assessed with validated questionnaires at baseline and 3 and 6 months after the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2008

Completed
Last Updated

July 20, 2011

Status Verified

June 1, 2008

Enrollment Period

3.8 years

First QC Date

June 25, 2008

Last Update Submit

July 19, 2011

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndromePatient education

Outcome Measures

Primary Outcomes (1)

  • Effect on GI symptoms as measured by IBS-SSS

    Basleline and 3 and 6 months

Secondary Outcomes (1)

  • Effects on Quality of life (IBSQOL), Psychological symptoms (HAD), GI specific anxiety (VSI) and knowledge about IBS.

    Baseline, 3 and 6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Structured patients group intervention - IBS school

Behavioral: IBS school

2

ACTIVE COMPARATOR

Written information - IBS-guidebook

Behavioral: IBS-guidebook

Interventions

IBS schoolBEHAVIORAL

Structured patient group education

1
IBS-guidebookBEHAVIORAL

Written information - IBS-guidebook

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women 18 to 70 years old, with IBS according to the Rome II criteria
  • Written informed consent

You may not qualify if:

  • An organic GI disease and/or with another disease potentially affecting the GI symptoms
  • Severe psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Magnus Simrén, MD, PhD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2008

First Posted

June 30, 2008

Study Start

August 1, 2004

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

July 20, 2011

Record last verified: 2008-06

Locations

SE(1)