Giardia Induced Fatigue and Functional Gastrointestinal D... | NCT00860236

Studies
Giardia Induced Fatigue and Functional Gastrointestinal Diseases

NCT00860236

Sponsor

University of Bergen

Status

Completed

Last Update Posted

Mar 3, 2017Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

Chronic Fatigue Syndrome

Interventions

Psycoeducation/counseling
Cognitive behavioural therapy

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jun 2010Actual

First Submitted Date

Mar 11, 2009

First Submission Date that Met QC Criteria

Mar 11, 2009

First Posted Date

Mar 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2017

Last Update Posted Date

Mar 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Psycoeducation/counseling	Active Comparator		Other: Psycoeducation/counseling
Cognitive behavioural therapy	Active Comparator		Behavioral: Cognitive behavioural therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Psycoeducation/counseling	Other	2 days of education on mechanisms of illness and coping strategies	Psycoeducation/counseling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Improvement minimum 6 points in Chalder Fatigue scale score		6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Problems with fatigue of any severity after Giardia infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bjarte Stubhaug, PhD	Frihamnsenteret	Study Director
Nina Langeland, PhD	University of Bergen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Frihamnsenteret		Skånevik			Norway

Condition Browse Module

MeSH Terms

ID	Term
D015673	Fatigue Syndrome, Chronic
D005873	Giardiasis
D005221	Fatigue

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D004679	Encephalomyelitis
D000090862	Neuroinflammatory Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003376	Counseling
D015928	Cognitive Behavioral Therapy

Ancestor Terms

ID	Term
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities
D003153	Community Health Services
D006296	Health Services

Browse Leaves

Not provided

Browse Branches

Not provided