NCT02011542

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 16, 2018

Completed
Last Updated

October 26, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

December 9, 2013

Results QC Date

December 12, 2017

Last Update Submit

October 24, 2018

Conditions

Gulf War Illness

Keywords

Irritable Bowel SyndromeGulf War Illness

Outcome Measures

Primary Outcomes (1)

  • 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

    8 weeks

Secondary Outcomes (1)

  • Change in Chronic Fatigue (1-5 Scale) From Baseline

    8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (not an active drug/ Inactive component) is given to this group

Drug: Placebo

VSL #3

ACTIVE COMPARATOR

VSL #3 (probiotic mixture) is given to this group

Drug: VSL#3

Interventions

VSL#3DRUG

This is a probiotic mixture

VSL #3
PlaceboDRUG

This is a pill with inactive ingredients.

Also known as: Placebo/ Sugar pill
Placebo

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George E Wahlen VA Medical Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Sugars

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Ashok Tuteja
Organization
University of Utah, Dept. of Gastroenterology
ashok.tuteja@hsc.utah.edu
801-581-5679

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Gastroenterology

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 13, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

October 26, 2018

Results First Posted

January 16, 2018

Record last verified: 2018-10

Locations

US(1)