Trial Outcomes & Findings for Probiotic (VSL #3) for Gulf War Illness (NCT NCT02011542)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

29 participants

Primary outcome timeframe

8 weeks

Results posted on

2018-10-26

Participant Flow

This study is ongoing; information on enrolled participant arm assignment is blinded, therefore these arms/groups are combined

Participant milestones

Participant milestones
Measure	VSL #3 or Placebo Study participants enrolled into the VSL #3 arm or the Placebo arm
Overall Study STARTED	30
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	VSL #3 or Placebo Study participants enrolled into the VSL #3 arm or the Placebo arm
Overall Study Physician Decision	1

Baseline Characteristics

Probiotic (VSL #3) for Gulf War Illness

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 8 weeks

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Population: 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.

Efficacy of VSL #3 in reducing non-intestinal symptoms of IBS is measured using chronic fatigue scale at 2,4,6,8, weeks

Outcome measures

Outcome data not reported

Adverse Events

VSL #3 or Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ashok Tuteja

University of Utah, Dept. of Gastroenterology

Phone: 801-581-5679

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place