Chronic Fatigue SyndromePhase 4GIFFNCT00860236
Giardia Induced Fatigue and Functional Gastrointestinal Diseases
A Phase 4 study testing Psycoeducation/counseling and Cognitive behavioural therapy in people with Chronic Fatigue Syndrome, run by University of Bergen at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Fatigue Syndrome
- What is being tested?
- Psycoeducation/counseling and Cognitive behavioural therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2009to Jun 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Problems with fatigue of any severity after Giardia infection
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chronic Fatigue Syndrome and Abdominal Symptoms After Giardia Infection: Clinical Evaluation, Biomarkers, Risk Factors and the Effect of Intervention
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
- Being tested
- Psycoeducation/counseling, Cognitive behavioural therapy
- Keywords
- CFS, Giardia, Fatigue, Cognitive behavioural therapy, CBT, Chronic fatigue syndrome
- Medical subject headings
- Fatigue Syndrome, Chronic, Giardiasis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycoeducation/counselingOther
2 days of education on mechanisms of illness and coping strategies
Cognitive behavioural therapyBehavioural
Also called CBT
4 days intensive training in understanding and behavioural changes
| Study group | Role | What they receive |
|---|---|---|
| Psycoeducation/counseling | Active comparator | Not described Receives: Other: Psycoeducation/counseling |
| Cognitive behavioural therapy | Active comparator | Not described Receives: Behavioral: Cognitive behavioural therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement minimum 6 points in Chalder Fatigue scale score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Investigators
- Bjarte Stubhaug, PhD, Study director, FrihamnsenteretNina Langeland, PhD, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860236
- Sponsor's protocol ID
- GIFF
- Acronym
- GIFF
- Status last verified
- Mar 2017
- First submitted
- 11 Mar 2009
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Fatigue Syndrome and Abdominal Symptoms After Giardia Infection: Clinical Evaluation, Biomarkers, Risk Factors and the Effect of Intervention
- ClinicalTrials.gov ID
- NCT00860236
- Acronym / sponsor ID
- GIFF / GIFF
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- CFS, Giardia, Fatigue, Cognitive behavioural therapy, CBT, Chronic fatigue syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 12 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psycoeducation/counseling | Active comparator | Other: Psycoeducation/counseling |
| Cognitive behavioural therapy | Active comparator | Behavioral: Cognitive behavioural therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Problems with fatigue of any severity after Giardia infection
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psycoeducation/counseling2 days of education on mechanisms of illness and coping strategies | Other | Psycoeducation/counseling |
| Cognitive behavioural therapyAlso: CBT4 days intensive training in understanding and behavioural changes | Behavioural | Cognitive behavioural therapy |
Primary outcome
Improvement minimum 6 points in Chalder Fatigue scale score
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
Related trials for Chronic Fatigue Syndrome
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bjarte Stubhaug, PhD study director
Frihamnsenteret
Nina Langeland, PhD principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Psycoeducation/counseling and Cognitive behavioural therapy in people with Chronic Fatigue Syndrome, run by University of Bergen at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement minimum 6 points in Chalder Fatigue scale score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.