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Clinical Trials/NCT00860236
NCT00860236CompletedPhase 4

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

University of Bergen1 site in 1 country40 target enrollmentStarted: March 2009Last updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Improvement minimum 6 points in Chalder Fatigue scale score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Problems with fatigue of any severity after Giardia infection

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Improvement minimum 6 points in Chalder Fatigue scale score

Time Frame: 6 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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