Giardia Induced Fatigue and Functional Gastrointestinal Diseases

NCT ID: NCT00860236

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-06-30

Brief Summary

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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

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Conditions

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Chronic Fatigue Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psycoeducation/counseling

Group Type ACTIVE_COMPARATOR

Psycoeducation/counseling

Intervention Type OTHER

2 days of education on mechanisms of illness and coping strategies

Cognitive behavioural therapy

Group Type ACTIVE_COMPARATOR

Cognitive behavioural therapy

Intervention Type BEHAVIORAL

4 days intensive training in understanding and behavioural changes

Interventions

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Psycoeducation/counseling

2 days of education on mechanisms of illness and coping strategies

Intervention Type OTHER

Cognitive behavioural therapy

4 days intensive training in understanding and behavioural changes

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT

Eligibility Criteria

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Inclusion Criteria

* Problems with fatigue of any severity after Giardia infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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University of Bergen

Principal Investigators

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Bjarte Stubhaug, PhD

Role: STUDY_DIRECTOR

Frihamnsenteret

Nina Langeland, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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Frihamnsenteret

Skånevik, , Norway

Site Status

Countries

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Norway

Related Links

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http://bgrg.uib.no

Bergen Giardia Research Group

Other Identifiers

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GIFF

Identifier Type: -

Identifier Source: org_study_id

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