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Giardia Induced Fatigue and Functional Gastrointestinal Diseases

NCT00860236 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-03-03

No results posted yet for this study

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.

Conditions

  • Chronic Fatigue Syndrome

Interventions

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

Sponsors & Collaborators

  • University of Bergen

    lead OTHER

Principal Investigators

  • Bjarte Stubhaug, PhD · Frihamnsenteret

  • Nina Langeland, PhD · University of Bergen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00860236 on ClinicalTrials.gov