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Probiotic (Visbiome) for Gulf War Illness

NCT03078530 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-12-13

No results posted yet for this study

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.

Conditions

  • Gulf War Illness

Interventions

DRUG

Placebo

This is a pill with inactive ingredients

DRUG

Visbiome

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

DRUG

VSL#3

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Ashok Tuteja

    lead FED

Principal Investigators

  • Ashok Tuteja, MD, MPH · George E Wahlen VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-13
Primary Completion
2018-05-31
Completion
2018-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03078530 on ClinicalTrials.gov