Probiotic (Visbiome) for Gulf War Illness | NCT03078530

Studies
Probiotic (Visbiome) for Gulf War Illness

NCT03078530

Sponsor

Ashok Tuteja

Status

Unknown status

Last Update Posted

Dec 13, 2017Actual

Enrollment

60Estimated

Phase

Phase 2Phase 3

Conditions

Gulf War Illness

Interventions

Placebo
Visbiome
VSL#3

Countries

United States

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

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 13, 2013Actual

Primary Completion Date

May 31, 2018Estimated

Completion Date

May 31, 2018Estimated

First Submitted Date

Mar 8, 2017

First Submission Date that Met QC Criteria

Mar 10, 2017

First Posted Date

Mar 13, 2017Actual

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

Dec 11, 2017

Last Update Posted Date

Dec 13, 2017Actual

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

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

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

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 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo (not an active drug/ Inactive component) is given to this group	Drug: Placebo
Visbiome	Experimental	Visbiome (probiotic mixture) is given to this group.	Drug: Visbiome
VSL #3	Experimental	VSL #3 (probiotic mixture) is given to this group	Drug: VSL#3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	This is a pill with inactive ingredients	Placebo	Placebo/ Sugar pill

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Baseline to 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.	baseline to 4 weeks
Change in chronic fatigue (1-5 scale) from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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,
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

Exclusion Criteria:

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
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ashok Tuteja, MD, MPH	Contact	8015821565	4019	ashok.tuteja@va.gov
Jaya Vijayan, MBBS	Contact	8015821565	4672	jaya.vijayan@va.gov

Overall Officials

Name	Affiliation	Role
Ashok Tuteja, MD, MPH	George E Wahlen VA Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
George E Wahlen VA Medical Center	Recruiting	Salt Lake City	Utah	84148	United States

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases