Back to resultsGiardia Induced Fatigue and Functional Gastrointestinal Diseases (GIFF)
Primary Purpose
Chronic Fatigue Syndrome
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Psycoeducation/counseling
Cognitive behavioural therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring CFS, Giardia, Fatigue, Cognitive behavioural therapy, CBT, Chronic fatigue syndrome
Eligibility Criteria
Inclusion Criteria:
- Problems with fatigue of any severity after Giardia infection
Sites / Locations
- Frihamnsenteret
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Psycoeducation/counseling
Cognitive behavioural therapy
Arm Description
Outcomes
Primary Outcome Measures
Improvement minimum 6 points in Chalder Fatigue scale score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00860236
Brief Title
Giardia Induced Fatigue and Functional Gastrointestinal Diseases
Acronym
GIFF
Official Title
Chronic Fatigue Syndrome and Abdominal Symptoms After Giardia Infection: Clinical Evaluation, Biomarkers, Risk Factors and the Effect of Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Bergen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
Keywords
CFS, Giardia, Fatigue, Cognitive behavioural therapy, CBT, Chronic fatigue syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Psycoeducation/counseling
Arm Type
Active Comparator
Arm Title
Cognitive behavioural therapy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Psycoeducation/counseling
Intervention Description
2 days of education on mechanisms of illness and coping strategies
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavioural therapy
Other Intervention Name(s)
CBT
Intervention Description
4 days intensive training in understanding and behavioural changes
Primary Outcome Measure Information:
Title
Improvement minimum 6 points in Chalder Fatigue scale score
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Problems with fatigue of any severity after Giardia infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjarte Stubhaug, PhD
Organizational Affiliation
Frihamnsenteret
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nina Langeland, PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frihamnsenteret
City
Skånevik
Country
Norway
12. IPD Sharing Statement
Links:
URL
http://bgrg.uib.no
Description
Bergen Giardia Research Group
Learn more about this trial
Giardia Induced Fatigue and Functional Gastrointestinal Diseases
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