Giardia Induced Fatigue and Functional Gastrointestinal Diseases (GIFF)
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|ClinicalTrials.gov Identifier: NCT00860236|
Recruitment Status : Completed
First Posted : March 12, 2009
Last Update Posted : March 3, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Fatigue Syndrome||Other: Psycoeducation/counseling Behavioral: Cognitive behavioural therapy||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chronic Fatigue Syndrome and Abdominal Symptoms After Giardia Infection: Clinical Evaluation, Biomarkers, Risk Factors and the Effect of Intervention|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
|Active Comparator: Psycoeducation/counseling||
2 days of education on mechanisms of illness and coping strategies
|Active Comparator: Cognitive behavioural therapy||
Behavioral: Cognitive behavioural therapy
4 days intensive training in understanding and behavioural changes
Other Name: CBT
- Improvement minimum 6 points in Chalder Fatigue scale score [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860236
|Study Director:||Bjarte Stubhaug, PhD||Frihamnsenteret|
|Principal Investigator:||Nina Langeland, PhD||University of Bergen|