Probiotic (Visbiome) for Gulf War Illness

NCT03078530 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: IRB_00059006
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective is to determine whether Visbiome will improve

1. 1.intestinal symptoms of Irritable Bowel Syndrome (IBS) and
2. 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.

Conditions

Gulf War Illness

Keywords

GWI; IBS; Irritable Bowel Syndrome; Gulf War Illness; Probiotics

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Change in chronic fatigue (1-5 scale) from baseline

  baseline to 4 weeks

• Change in chronic fatigue (1-5 scale) from baseline

  baseline to 8 weeks

Study Arms (3)

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

Placebo DRUG

This is a pill with inactive ingredients

Also known as: Placebo/ Sugar pill

Placebo

Visbiome DRUG

This is a probiotic mixture available to randomized study participants, starting with subject 29

Visbiome

VSL#3 DRUG

This is a probiotic mixture available to the first 28 subjects randomized to the study

VSL #3

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ashok Tuteja: lead
• United States Department of Defense: collaborator

Study Sites (1)

George E Wahlen VA Medical Center

Salt Lake City, Utah, 84148, United States

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Sugars

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Ashok Tuteja, MD, MPH

  George E Wahlen VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashok Tuteja, MD, MPH

CONTACT

8015821565; ashok.tuteja@va.gov

Jaya Vijayan, MBBS

CONTACT

8015821565; jaya.vijayan@va.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Gastroenterology

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 13, 2017
• Study Start: September 13, 2013
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: December 13, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)