ClinicalTrials.gov
ClinicalTrials.gov Menu

Giardia Induced Fatigue and Functional Gastrointestinal Diseases (GIFF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00860236
Recruitment Status : Completed
First Posted : March 12, 2009
Last Update Posted : March 3, 2017
Sponsor:
Information provided by:
University of Bergen

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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Psycoeducation/counseling Other: 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




Primary Outcome Measures :
  1. Improvement minimum 6 points in Chalder Fatigue scale score [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Problems with fatigue of any severity after Giardia infection

Information from the National Library of Medicine

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


Locations
Norway
Frihamnsenteret
Skånevik, Norway
Sponsors and Collaborators
University of Bergen
Investigators
Study Director: Bjarte Stubhaug, PhD Frihamnsenteret
Principal Investigator: Nina Langeland, PhD University of Bergen

Additional Information:
Responsible Party: Nina Langeland, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT00860236     History of Changes
Other Study ID Numbers: GIFF
First Posted: March 12, 2009    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by University of Bergen:
CFS
Giardia
Fatigue
Cognitive behavioural therapy
CBT
Chronic fatigue syndrome

Additional relevant MeSH terms:
Syndrome
Fatigue
Fatigue Syndrome, Chronic
Gastrointestinal Diseases
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Digestive System Diseases