Giardia Induced Fatigue and Functional Gastrointestinal Diseases (GIFF)

University of Bergen

Status and phase: Completed; Phase 4

Conditions: Chronic Fatigue Syndrome

Treatments: Other: Psycoeducation/counseling; Behavioral: Cognitive behavioural therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00860236

GIFF

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Problems with fatigue of any severity after Giardia infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Psycoeducation/counseling

Active Comparator group

Treatment:

Other: Psycoeducation/counseling

Cognitive behavioural therapy

Active Comparator group

Treatment:

Behavioral: Cognitive behavioural therapy