NCT03078530 is a Phase 2, PHASE3 clinical trial of Visbiome in Gulf War Illness, sponsored by Ashok Tuteja.

Who is sponsoring NCT03078530?

NCT03078530 is sponsored by Ashok Tuteja.

What drugs are being tested in NCT03078530?

Interventions in NCT03078530: Placebo, Visbiome, VSL#3.

What condition does NCT03078530 study?

NCT03078530 studies Gulf War Illness.

Is NCT03078530 still recruiting?

NCT03078530 is currently status unknown. Last updated 13 December 2017.

Last reviewed 2017-12-13 · How we verify

NCT03078530

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Probiotic (Visbiome) for Gulf War Illness

Status unknown Phase 2, PHASE3 Last updated 13 December 2017

What this trial tests

Phase 2, PHASE3 trial testing Placebo in Gulf War Illness in 60 participants. Status unknown.

Timeline

13 September 2013

Primary endpoint
31 May 2018

31 May 2018

Quick facts

Lead sponsor	Ashok Tuteja
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	60
Start date	13 September 2013
Primary completion	31 May 2018
Estimated completion	31 May 2018
Sites	1 location across United States

Drugs / interventions tested

Placebo
Visbiome — full drug profile →
VSL#3 — full drug profile →

Conditions studied

Gulf War Illness — all drugs for Gulf War Illness →

Sponsor

Ashok Tuteja

Who can join

Adults 35 to 75, any sex, with Gulf War Illness. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Gulf War Illness: Mechanisms Underlying Brain Dysfunction and Promising Therapeutic Strategies.
Dickey B, Madhu LN, Shetty AK. · · 2021 · cited 54× · PMID 33164782 · DOI 10.1016/j.pharmthera.2020.107716
Randomized, Double-Blind Placebo-Controlled Trial to Assess the Effect of Probiotics on Irritable Bowel Syndrome in Veterans With Gulf War Illness.
Tuteja AK, Talley NJ, Murtaugh MA, Loc-Carrillo CM, et al · · 2022 · cited 2× · PMID 36744017 · DOI 10.12788/fp.0322
A Double-Humanized Mouse Model for Studying Host Gut Microbiome-Immune Interactions in Gulf War Illness.
Bose D, Saha P, Roy S, Trivedi A, et al · · 2024 · cited 1× · PMID 38892281 · DOI 10.3390/ijms25116093

Verify or expand the search:

Other trials of Visbiome

Trials testing the same drug.

NCT07415707 — The GLUCID Study: Effect of Alcohol Reduction and Probiotic Interventions on Cognition and Brain Glucose Metabolism in N · NA · recruiting
NCT04281407 — Impact of Probiotics on Drug, Vitamin, and Hormone Metabolism · NA · unknown
NCT04141761 — Probiotics in Newly Diagnosed T1D · Phase 2 · active not recruiting
NCT03524638 — Visbiome Effect on Colorectal Anastomosis and Local Recurrence · NA · withdrawn
NCT02441244 — Probiotic Visbiome for Inflammation and Translocation in HIV Ι · Phase 2 · terminated

Other recruiting trials for Gulf War Illness

Currently open trials in the same condition.

NCT05820893 — Resistant Potato Starch to Alleviate GWI · Phase 2 · recruiting
NCT05367245 — Ca-Mg Butyrate in GWI · Phase 2 · recruiting
NCT05972291 — Mechanisms of Gulf War Illness · NA · recruiting
NCT05375812 — NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH) · recruiting
NCT05675878 — Confirmation of Diet as a Treatment for Gulf War Illness · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03078530 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Ashok Tuteja
Last refreshed: 13 December 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03078530.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing