Giardia Induced Fatigue and Functional Gastrointestinal Diseases (GIFF)

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

University of Bergen

ClinicalTrials.gov Identifier:

NCT00860236

First received: March 11, 2009

Last updated: April 22, 2009

Last verified: April 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	March 11, 2009
Last Updated Date	April 22, 2009
Start Date ^ICMJE	March 2009
Estimated Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 11, 2009)	Improvement minimum 6 points in Chalder Fatigue scale score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00860236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Giardia Induced Fatigue and Functional Gastrointestinal Diseases
Official Title ^ICMJE	Chronic Fatigue Syndrome and Abdominal Symptoms After Giardia Infection: Clinical Evaluation, Biomarkers, Risk Factors and the Effect of Intervention
Brief Summary	A giardiasis outbreak in Bergen has given us the opportunity to approach two basic research questions of national and global importance: Studying the pathoimmunology of giardiasis in a natural setting, and following the genetic and immunological responses leading to recovery or persistent disease and sequelae. Studying the two disease entities FGID and CFS when induced by acute giardiasi and their risk factors. Interventional cognitive behavioural therapy is the only intervention documented to have significant effect on CFS outcome, and conventional cognitive behavioural therapy will be compared to a psycho-educational programme in the format of a randomised controlled trial.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Chronic Fatigue Syndrome
Intervention ^ICMJE	Other: Psycoeducation/counseling 2 days of education on mechanisms of illness and coping strategies Behavioral: Cognitive behavioural therapy 4 days intensive training in understanding and behavioural changes Other Name: CBT
Study Arm (s)	Active Comparator: Psycoeducation/counseling Intervention: Other: Psycoeducation/counseling Active Comparator: Cognitive behavioural therapy Intervention: Behavioral: Cognitive behavioural therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	40
Estimated Completion Date	December 2010
Estimated Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Problems with fatigue of any severity after Giardia infection
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Norway

Administrative Information
NCT Number ^ICMJE	NCT00860236
Other Study ID Numbers ^ICMJE	GIFF
Has Data Monitoring Committee	No
Responsible Party	Nina Langeland, Professor, University of Bergen
Study Sponsor ^ICMJE	University of Bergen
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Bergen
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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