Gulf War IllnessPhase 2/3NCT02011542

Probiotic (VSL #3) for Gulf War Illness

A Phase 2/3 study testing VSL#3 in people with Gulf War Illness, run by University of Utah at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The overall objective is to determine whether VSL #3 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?: VSL#3
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 29 participants
Where: 1 siteUnited States
Study dates: Sep 2013to Jul 2016
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

George E Wahlen VA Medical Center
Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: Probiotics (VSL #3) for Gulf War Illness

Read the detailed description

Specific Aims:

Aim # 1: Determine the efficacy of VSL #3 on IBS symptoms in GW veterans.

Hypothesis: Treatment with VSL #3 compared to placebo will improve global and individual symptoms of IBS

Aim #2 Determine the efficacy VSL #3 in reducing non-intestinal symptoms of IBS (fatigue, joint pain, insomnia, general stiffness and headache).

Hypothesis: Treatment with VSL #3 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: VSL#3, Placebo
Keywords: Irritable Bowel Syndrome, Gulf War Illness
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.

VSL#3Drug
This is a probiotic mixture
PlaceboDrug
Also called Placebo/ Sugar pill
This is a pill with inactive ingredients.

Study groups in NCT02011542
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo (not an active drug/ Inactive component) is given to this group Receives: Drug: Placebo
VSL #3	Active comparator	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.

Improvement in the Bowel Symptom Scale (BSS) From Baseline
Efficacy of VSL #3 in Irritable Bowel Syndrome (IBS) related symptoms in Gulf War illness is measured using BSS at 2, 4, 6, 8 wks
Measured: 8 weeks

Secondary outcomes (1)

Change in Chronic Fatigue (1-5 Scale) From Baseline
Efficacy of VSL #3 in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 2,4,6,8, weeks
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Jul 2016

First posted13 Dec 2013 (estimated)
Study startSep 2013
Primary completionJul 2016
Study completionJul 2016

Why it stopped: Original study product (VSL #3) became unavailable; change in study Collaborator and product

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02011542
Sponsor's protocol ID: W81XWH-10-1-0593
Status last verified: Oct 2018
First submitted: 9 Dec 2013
Last updated: 26 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
Gulf War Illness
RecruitingPhase 2
Ca-Mg Butyrate in Gulf War Illness
Gulf War Illness, Chronic Fatigue
Recruiting
Mechanisms of Gulf War Illness
Gulf War Illness, Irritable Bowel Syndrome
RecruitingPhase 2
Resistant Potato Starch to Alleviate GWI
Gulf War Illness
Recruiting
Machine Learning in Guiding rTMS Treatment for GWI-Related Headaches and Body Pain
Gulf War Illness, Headache

All Gulf War Illness trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Probiotics (VSL #3) for Gulf War Illness
ClinicalTrials.gov ID: NCT02011542
Acronym / sponsor ID: W81XWH-10-1-0593
Conditions: Gulf War Illness
Keywords: Irritable Bowel Syndrome, Gulf War Illness
Phase: Phase 2/3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Original study product (VSL #3) became unavailable; change in study Collaborator and product
Enrolment: 29 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Collaborators: United States Department of Defense
Study start: Sep 2013
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 13 Dec 2013 (estimated)
Results: Posted 16 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Specific Aims:

Aim # 1: Determine the efficacy of VSL #3 on IBS symptoms in GW veterans.

Hypothesis: Treatment with VSL #3 compared to placebo will improve global and individual symptoms of IBS

Aim #2 Determine the efficacy VSL #3 in reducing non-intestinal symptoms of IBS (fatigue, joint pain, insomnia, general stiffness and headache).

Hypothesis: Treatment with VSL #3 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: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPlacebo (not an active drug/ Inactive component) is given to this group
VSL #3	Active comparator	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
VSL#3This is a probiotic mixture	Drug	VSL #3
PlaceboAlso: Placebo/ Sugar pillThis is a pill with inactive ingredients.	Drug	Placebo

Primary outcome

Improvement in the Bowel Symptom Scale (BSS) From Baseline
Time frame: 8 weeks
Efficacy of VSL #3 in Irritable Bowel Syndrome (IBS) related symptoms in Gulf War illness is measured using BSS at 2, 4, 6, 8 wks

1 secondary outcome

Change in Chronic Fatigue (1-5 Scale) From Baseline
Time frame: 8 weeks

Results and safety

Results posted to the registry on 16 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VSL #3 or Placebo	30	29

Primary outcome: Improvement in the Bowel Symptom Scale (BSS) From Baseline

Time frame: 8 weeks

Population analysed: Clinical trial is ongoing; change in collaborator and investigational product required new study registration. Clinical trial results for all participants will be reported upon study completion in record NCT03078530.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VSL #3 or Placebo	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): Clinical trial is ongoing; change in collaborator and investigational product required new study registration. Clinical trial results for all participants will be reported upon study completion in record NCT03078530.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Gulf War Illness

RecruitingObservational study
NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
Gulf War Illness
RecruitingPhase 2
Ca-Mg Butyrate in Gulf War Illness
Gulf War Illness, Chronic Fatigue
Recruiting
Mechanisms of Gulf War Illness
Gulf War Illness, Irritable Bowel Syndrome
RecruitingPhase 2
Resistant Potato Starch to Alleviate GWI
Gulf War Illness
Recruiting
Machine Learning in Guiding rTMS Treatment for GWI-Related Headaches and Body Pain
Gulf War Illness, Headache

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.

The record lists no contact. Use the official record to reach the sponsor.

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 VSL#3 in people with Gulf War Illness, run by University of Utah 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: stopped early, as of the sponsor's last update on 26 Oct 2018. 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?

Yes. Results are posted in the registry (first posted 16 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in the Bowel Symptom Scale (BSS) From Baseline (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02011542.

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 26 Oct 2018; AzTrials last refreshed its copy on 30 Oct 2026.