Giardia Induced Fatigue and Functional Gastrointestinal Diseases

Phase 4

Completed

• Conditions: Chronic Fatigue Syndrome
• Interventions: Other: Psycoeducation/counseling; Behavioral: Cognitive behavioural therapy

• Registration Number: NCT00860236
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-11
• Study First Submitted QC: 2009-03-11
• Study First Posted: 2009-03-12
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Problems with fatigue of any severity after Giardia infection

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psycoeducation/counseling	Psycoeducation/counseling	-
Cognitive behavioural therapy	Cognitive behavioural therapy	-

Primary Outcome Measures

Name	Time	Method
Improvement minimum 6 points in Chalder Fatigue scale score	6 months

Trial Locations

Locations (1)

Frihamnsenteret; 🇳🇴 Skånevik, Norway