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NCT00860236 Clinical Trial

Giardia Induced Fatigue and Functional Gastrointestinal Diseases

Chronic Fatigue Syndrome Clinical Trial

— GIFF  

Official title:
Chronic Fatigue Syndrome and Abdominal Symptoms After Giardia Infection: Clinical Evaluation, Biomarkers, Risk Factors and the Effect of Intervention

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00860236
Other study ID # GIFF
Secondary ID
Status Completed
Phase Phase 4
First received March 11, 2009
Last updated March 1, 2017
Start date March 2009
Est. completion date June 2010

Study information
Verified date March 2017
Source University of Bergen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 2010
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Problems with fatigue of any severity after Giardia infection

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Norway Frihamnsenteret Skånevik

Sponsors (1)
Lead Sponsor Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement minimum 6 points in Chalder Fatigue scale score 6 months
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