NCT01153295

Brief Summary

The study aims to investigate how to give the diagnosis of Irritable Bowel Syndrome. The investigators compare two parallel groups of primary care patients, in the age of 18-50 years with gastrointestinal complaints where the GP suspects IBS. All included patients fulfil international diagnostic criteria (ROME III) and have no danger signals. Group 1: The diagnosis is based on the diagnostic criteria and few blod tests Group 2: The diagnosis is a diagnosis of exclusion after investigations with extended blod tests, examination for milk- and gluten intolerance, stoll for ova and parasites and scopy of the intestine. After receiving the diagnosis of Irritable bowel syndrome all patients are informed about the condition. The investigators follow the patients for 1 year. The investigators hypothesis is that the two investigation programmes (group 1 and 2)are equal with respect to the patients´ quality of life, symptoms and satisfaction and also with respect to finding of organic diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 30, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 25, 2011

Status Verified

December 1, 2008

Enrollment Period

2.5 years

First QC Date

June 28, 2010

Last Update Submit

October 24, 2011

Conditions

Irritable Bowel Syndrome

Keywords

IBSIrritable bowel syndromediagnosissafetyHealth related quality of life

Outcome Measures

Primary Outcomes (1)

  • Health related quality of life

    One year

Secondary Outcomes (1)

  • Findings of organic disease

    one year

Study Arms (2)

Positive diagnosis

EXPERIMENTAL

The diagnosis of IBS is based on the international ROME III criteria, few blod tests, and abscence of danger signals

Procedure: Clinical diagnosis based on symptom criteria

Diagnosis of exclusion

ACTIVE COMPARATOR

The diagnosis of IBS is based on normal extended blood tests, screening for celiac sprue and lactose intolerance, stool for ova and parasites and endoscopy with biopsy

Procedure: Diagnosis of exclusion

Interventions

Clinical diagnosis based on symptom criteriaPROCEDURE

The diagnosis is based on ROME III criteria, abscence of danger signals and FBC, CRP

Positive diagnosis
Diagnosis of exclusionPROCEDURE

The diagnosis is based on normal investigations involving endoscopy with biopsy, stool for ova and parasites, FBC, CRP, TSH, Ca, ALT, alanine aminotransferase; alkaline phosphatase, serum bilirubin, Screening for lactose and celiac sprue

Diagnosis of exclusion

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Fulfill ROME III criteria
  • age 18-50 years
  • signed informed content

You may not qualify if:

  • Danger signals (fever, anaemia, weightloss, blod in stools, predisposition for CRC or IBD)
  • abnormal physical examination
  • comorbidity
  • abuse
  • lacking ability to talk and understand danish
  • pregnancy
  • Performed endoscopy within the last 3 years
  • For patients \> 40 years. Changed bowel habits, with duration \> 3 weeks, but \< 1 year
  • Age \< 18 years and \> 50 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Unit for General Practice, Department of gastroenterology, Odense University hospital

Odense, Odense, 5000, Denmark

Location

Related Publications (2)

  • Engsbro AL, Begtrup LM, Haastrup P, Storsveen MM, Bytzer P, Kjeldsen J, Schaffalitzky De Muckadell O, Jarbol DE. A positive diagnostic strategy is safe and saves endoscopies in patients with irritable bowel syndrome: A five-year follow-up of a randomized controlled trial. Neurogastroenterol Motil. 2021 Mar;33(3):e14004. doi: 10.1111/nmo.14004. Epub 2020 Oct 7.

    PMID: 33029843DERIVED

  • Begtrup LM, Engsbro AL, Kjeldsen J, Larsen PV, Schaffalitzky de Muckadell O, Bytzer P, Jarbol DE. A positive diagnostic strategy is noninferior to a strategy of exclusion for patients with irritable bowel syndrome. Clin Gastroenterol Hepatol. 2013 Aug;11(8):956-62.e1. doi: 10.1016/j.cgh.2012.12.038. Epub 2013 Jan 26.

    PMID: 23357491DERIVED

MeSH Terms

Conditions

Irritable Bowel SyndromeDisease

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ove B. Schaffalitzky de Muckadell, Professor

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 28, 2010

First Posted

June 30, 2010

Study Start

December 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 25, 2011

Record last verified: 2008-12

Locations

DK(1)