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GIFF: Giardia Induced Fatigue and Functional Gastrointestinal Diseases

Sponsor
University of Bergen (Other)
Overall Status
Completed
CT.gov ID
NCT00860236
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
15
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Psycoeducation/counseling
  • Behavioral: Cognitive behavioural therapy
 Phase 4

Study Design

Study Type:
Interventional
Anticipated 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 :
Mar 1, 2009
Actual Primary Completion Date :
Jun 1, 2010
Actual Study Completion Date :
Jun 1, 2010

Arms and Interventions

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 Names:
  • CBT

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Improvement minimum 6 points in Chalder Fatigue scale score [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Problems with fatigue of any severity after Giardia infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Frihamnsenteret Skånevik Norway

    Sponsors and Collaborators

    • University of Bergen

    Investigators

    • Study Director: Bjarte Stubhaug, PhD, Frihamnsenteret
    • Principal Investigator: Nina Langeland, PhD, University of Bergen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00860236
    Other Study ID Numbers:
    • GIFF
    First Posted:
    Mar 12, 2009
    Last Update Posted:
    Mar 3, 2017
    Last Verified:
    Mar 1, 2017
    Keywords provided by , ,
    CFS
    Giardia
    Fatigue
    Cognitive behavioural therapy
    CBT
    Chronic fatigue syndrome
    Additional relevant MeSH terms:
    Fatigue Syndrome, Chronic
    Syndrome
    Fatigue

    Study Results

    No Results Posted as of Mar 3, 2017