Gulf War IllnessPhase 2/3NCT03078530
Probiotic (Visbiome) for Gulf War Illness
A Phase 2/3 study testing Visbiome and VSL#3 in people with Gulf War Illness, run by Ashok Tuteja at 1 site in United States.
Trial summary
The overall objective is to determine whether Visbiome will improve 1. intestinal symptoms of Irritable Bowel Syndrome (IBS) and 2. non-intestinal symptoms (fatigue, joint pain, insomnia, general stiffness and headache) associated with IBS. All of these symptoms are part of the Gulf War (GW) illness. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- Visbiome and VSL#3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2013to 31 May 2018
- Phase
- Phase 2/3
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First GW veterans, Men and women age 35-75 years,
- Rome III criteria for IBS and two or more of the non-intestinal symptoms (chronic-once a week or more often-fatigue, joint pains, insomnia, general stiffness, and headache)
- Symptoms of > 6 months duration,
- No significant findings on physical examination, Complete Blood Count (CBC) and clinical chemistry panel.
- Normal gross appearance of the colonic mucosa other than erythema and polyps
- Negative Tissue transglutaminase (TTG) for celiac disease,
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- Normal thyroid function.
- Veterans with psychological disorders will not be excluded but will be identified for sub-group analysis.
- Stable medication regimen for more than a month
Who cannot join
- Current evidence of any lower gastrointestinal disorder such as celiac disease or inflammatory bowel disease
- History of/or presence of systemic malignancy (patients with skin and other cancers in remission for more than 5 years are allowed in the study
- Clinically significant chronic disease: HIV, cardiac, pulmonary, hepatic or renal dysfunction.
- Presence of Giardia antigen, and Clostridium difficile toxin in stool,
- Abnormal blood test for thyroid stimulating hormone, tissue transglutaminase antibody
- Current effects of drug or alcohol abuse
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- Investigator perception of patient's inability to comply with study protocol
- Recent change in gastrointestinal medications
- Use of any antibiotic in the last 1 months
- Positive pregnancy test
- Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
George E Wahlen VA Medical Center
Salt Lake City, Utah, 84148
Ashok Tuteja,, MD, MPH, 801-582-1565 ext. 4019, ashok.tuteja@va.gov
Jaya Vijayan, MBBS, 8015821565 ext. 4672, jaya.vijayan@va.gov
About this study
The overall objective is to determine whether Visbiome will improve
- intestinal symptoms of Irritable Bowel Syndrome (IBS) and
- non-intestinal symptoms (fatigue, joint pain, insomnia, general stiffness and headache) associated with IBS. All of these symptoms are part of the Gulf War (GW) illness.
Read the detailed description
Specific Aims:
Aim # 1: Determine the efficacy of Visbiome on IBS symptoms in GW veterans.
Hypothesis: Treatment with Visbiome compared to placebo will improve global and individual symptoms of IBS
Aim #2 Determine the efficacy Visbiome in reducing non-intestinal symptoms of IBS (fatigue, joint pain, insomnia, general stiffness and headache).
Hypothesis: Treatment with Visbiome compared to placebo will improve non-intestinal symptoms of IBS in GW veterans.
Aim #3 Determine whether changes in gut flora and plasma cytokines correlate with treatment response in GW veterans
- Conditions
- Gulf War Illness
- Being tested
- Placebo, Visbiome, VSL#3
- Keywords
- GWI, IBS, Irritable Bowel Syndrome, Gulf War Illness, Probiotics
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Placebo/ Sugar pill
This is a pill with inactive ingredients
VisbiomeDrug
This is a probiotic mixture available to randomized study participants, starting with subject 29
VSL#3Drug
This is a probiotic mixture available to the first 28 subjects randomized to the study
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (not an active drug/ Inactive component) is given to this group Receives: Drug: Placebo |
| Visbiome | Experimental | Visbiome (probiotic mixture) is given to this group. Receives: Drug: Visbiome |
| VSL #3 | Experimental | VSL #3 (probiotic mixture) is given to this group Receives: Drug: VSL#3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the bowel symptom scale from the baseline
Efficacy of Visbiome in IBS related symptoms in GW illness is measured using BSS at 8 weeks
Measured: Baseline to 8 weeks
Secondary outcomes (2)
Change in chronic fatigue (1-5 scale) from baseline
Efficacy of Visbiome in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 4 weeks.
Measured: baseline to 4 weeks
Change in chronic fatigue (1-5 scale) from baseline
Efficacy of Visbiome in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 8 weeks.
Measured: baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start13 Sep 2013
- Primary completion31 May 2018 (estimated)
- Study completion31 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War IllnessStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ashok Tuteja
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Ashok Tuteja, VA Salt Lake City Health Care System
- Investigators
- Ashok Tuteja, MD, MPH, Principal investigator, George E Wahlen VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078530
- Sponsor's protocol ID
- IRB_00059006
- Status last verified
- Dec 2017
- First submitted
- 8 Mar 2017
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic (Visbiome) for Gulf War Illness
- ClinicalTrials.gov ID
- NCT03078530
- Acronym / sponsor ID
- IRB_00059006
- Conditions
- Gulf War Illness
- Keywords
- GWI, IBS, Irritable Bowel Syndrome, Gulf War Illness, Probiotics
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ashok TutejaUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- 13 Sep 2013 (actual)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 31 May 2018 (estimated)
- First posted
- 13 Mar 2017 (actual)
- 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.
The overall objective is to determine whether Visbiome will improve
- intestinal symptoms of Irritable Bowel Syndrome (IBS) and
- non-intestinal symptoms (fatigue, joint pain, insomnia, general stiffness and headache) associated with IBS. All of these symptoms are part of the Gulf War (GW) illness.
Detailed description
Specific Aims:
Aim # 1: Determine the efficacy of Visbiome on IBS symptoms in GW veterans.
Hypothesis: Treatment with Visbiome compared to placebo will improve global and individual symptoms of IBS
Aim #2 Determine the efficacy Visbiome in reducing non-intestinal symptoms of IBS (fatigue, joint pain, insomnia, general stiffness and headache).
Hypothesis: Treatment with Visbiome compared to placebo will improve non-intestinal symptoms of IBS in GW veterans.
Aim #3 Determine whether changes in gut flora and plasma cytokines correlate with treatment response in GW veterans
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (not an active drug/ Inactive component) is given to this group |
| Visbiome | Experimental | Drug: VisbiomeVisbiome (probiotic mixture) is given to this group. |
| VSL #3 | Experimental | Drug: VSL#3VSL #3 (probiotic mixture) is given to this group |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- First GW veterans, Men and women age 35-75 years,
- Rome III criteria for IBS and two or more of the non-intestinal symptoms (chronic-once a week or more often-fatigue, joint pains, insomnia, general stiffness, and headache)
- Symptoms of > 6 months duration,
- No significant findings on physical examination, Complete Blood Count (CBC) and clinical chemistry panel.
- Normal gross appearance of the colonic mucosa other than erythema and polyps
Key exclusion criteria (11 listed)
- Current evidence of any lower gastrointestinal disorder such as celiac disease or inflammatory bowel disease
- History of/or presence of systemic malignancy (patients with skin and other cancers in remission for more than 5 years are allowed in the study
- Clinically significant chronic disease: HIV, cardiac, pulmonary, hepatic or renal dysfunction.
- Presence of Giardia antigen, and Clostridium difficile toxin in stool,
- Abnormal blood test for thyroid stimulating hormone, tissue transglutaminase antibody
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 |
|---|---|---|
| PlaceboAlso: Placebo/ Sugar pillThis is a pill with inactive ingredients | Drug | Placebo |
| VisbiomeThis is a probiotic mixture available to randomized study participants, starting with subject 29 | Drug | Visbiome |
| VSL#3This is a probiotic mixture available to the first 28 subjects randomized to the study | Drug | VSL #3 |
Primary outcome
Change in the bowel symptom scale from the baseline
Time frame: Baseline to 8 weeks
Efficacy of Visbiome in IBS related symptoms in GW illness is measured using BSS at 8 weeks
2 secondary outcomes
Change in chronic fatigue (1-5 scale) from baseline
Time frame: baseline to 4 weeks
Change in chronic fatigue (1-5 scale) from baseline
Time frame: baseline to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Gulf War Illness
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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.
Ashok Tuteja, MD, MPH principal investigator
George E Wahlen VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Visbiome and VSL#3 in people with Gulf War Illness, run by Ashok Tuteja at 1 site in United States.
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Dec 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashok Tuteja, MD, MPH (8015821565 ext. 4019, ashok.tuteja@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the bowel symptom scale from the baseline (time frame: Baseline to 8 weeks). 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 13 Dec 2017.