Trial Outcomes & Findings for Gulf War Digestive Health Study (NCT NCT00680836)

NCT ID: NCT00680836

Last Updated: 2014-08-29

Results Overview

Improvement in Irritable Bowel Syndrome symptoms post treatment is measured. This scale is not measured at baseline. Participants are asked if their symptoms improved or got worse and to rate it on a scale of 1- 7 for seven days. Average score for 7 days is calculated. The Global improvement scale ranges from 1- 7. Score of 1-3 means the IBS symptoms got worse, 4 means no change and 5-7 means improvement in the IBS symptoms.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: Measured for seven days at the end of 2 weeks treatment and average score is calculated
• Results posted on: 2014-08-29

Participant Flow

Participant milestones

Measure	Placebo Group These patients have Irritable Bowel syndrome and are receiving the placebo twice a day	Active Group These patients have Irritable Bowel syndrome and are receiving rifaximin 550mg twice a day
Overall Study STARTED	27	27
Overall Study COMPLETED	19	25
Overall Study NOT COMPLETED	8	2

Reasons for withdrawal

Measure	Placebo Group These patients have Irritable Bowel syndrome and are receiving the placebo twice a day	Active Group These patients have Irritable Bowel syndrome and are receiving rifaximin 550mg twice a day
Overall Study Withdrawal by Subject	3	0
Overall Study Lost to Follow-up	3	1
Overall Study Physician Decision	2	1

Baseline Characteristics

Gulf War Digestive Health Study

Baseline characteristics by cohort

Measure	Placebo n=19 Participants These patients have Irritable Bowel syndrome (IBS) and are receiving the placebo twice a day	Treatment n=25 Participants These patients have Irritable Bowel syndrome (IBS) and are receiving the rifaximin 550mg twice a day	Total n=44 Participants Total of all reporting groups
Age, Customized	52 years n=93 Participants	56 years n=4 Participants	52 years n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	5 Participants n=4 Participants	6 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	20 Participants n=4 Participants	38 Participants n=27 Participants
Region of Enrollment United States	19 participants n=93 Participants	25 participants n=4 Participants	44 participants n=27 Participants

PRIMARY outcome

Timeframe: Measured for seven days at the end of 2 weeks treatment and average score is calculated

Improvement in Irritable Bowel Syndrome symptoms post treatment is measured. This scale is not measured at baseline. Participants are asked if their symptoms improved or got worse and to rate it on a scale of 1- 7 for seven days. Average score for 7 days is calculated. The Global improvement scale ranges from 1- 7. Score of 1-3 means the IBS symptoms got worse, 4 means no change and 5-7 means improvement in the IBS symptoms.

Outcome measures

Measure	Placebo Group n=19 Participants These patients have IBS and are receiving placebo tablets twice a day	Active Group n=25 Participants These patients have IBS and are receiving the rifaximin 550mg twice a day
Global Improvement Scale	4.3 units on a scale Standard Deviation 1.0	4.3 units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 2 weeks

Change in stool frequency (number of bowel movements per day) compared from baseline to post treatment is measured. Number of bowel movements per day before treatment is subtracted from the number of bowel movements per day after treatment. The change in frequency has been reported in the outcomes table.

Outcome measures

Measure	Placebo Group n=19 Participants These patients have IBS and are receiving placebo tablets twice a day	Active Group n=25 Participants These patients have IBS and are receiving the rifaximin 550mg twice a day
Change in Stool Frequency (Number of Bowel Movements Per Day)	-0.3 Bowel movements/ day Interval -0.7 to 0.2	-0.1 Bowel movements/ day 95% Confidence Interval 0.2 • Interval -0.4 to 0.2

SECONDARY outcome

Timeframe: 2 weeks

Change in Stool consistency from baseline to post treatment is measured. Bristol stool scale is used for this purpose. The scale ranges from a value of 1- 7; 1 being very hard stool to 7 being liquid stools. The change is measured for 1 week post-treatment and the average consistency is used for the purpose of measuring change from baseline.

Outcome measures

Measure	Placebo Group n=19 Participants These patients have IBS and are receiving placebo tablets twice a day	Active Group n=25 Participants These patients have IBS and are receiving the rifaximin 550mg twice a day
Change in Stool Consistency	-0.4 units on a scale (BSS) 95% Confidence Interval 0.2 • Interval -0.9 to 0.1	-0.3 units on a scale (BSS) 95% Confidence Interval 0.2 • Interval -0.7 to 0.1

SECONDARY outcome

Timeframe: 2 weeks

Urgency in a bowel movements compared from baseline to post treatment was measured. Participants were asked to note if they had urgency at bowel movements (meaning if they had to rush to the restroom). They marked either 'yes' or 'no'. The percentage of the time they said yes was calculated for 7 days. The difference between baseline and post treatment urgency was calculated.

Outcome measures

Measure	Placebo Group n=19 Participants These patients have IBS and are receiving placebo tablets twice a day	Active Group n=25 Participants These patients have IBS and are receiving the rifaximin 550mg twice a day
Change in Bowel Urgency	0.0 difference in percentage of 'Yes' 95% Confidence Interval 0.1 • Interval -0.2 to 0.2	-0.1 difference in percentage of 'Yes' 95% Confidence Interval 0.1 • Interval -0.3 to 0.1

SECONDARY outcome

Timeframe: 2 weeks

Severity of abdominal pain on a scale of 0 to 4 was measured; 0 meaning no pain to 4 meaning severe pain. Change in abdominal pain from baseline to post treatment was calculated.

Outcome measures

Measure	Placebo Group n=19 Participants These patients have IBS and are receiving placebo tablets twice a day	Active Group n=25 Participants These patients have IBS and are receiving the rifaximin 550mg twice a day
Change in Abdominal Pain With Bowel Movement	-0.3 units on a scale 95% Confidence Interval 0.2 • Interval -0.9 to 0.3	-0.2 units on a scale 95% Confidence Interval 0.2 • Interval -0.6 to 0.2

SECONDARY outcome

Timeframe: 2 weeks

Bloating is measured on a scale from 0 to 4; 0 = no bloating to 4 = severe bloating. Change in bloating is calculated from baseline to post treatment.

Outcome measures

Measure	Placebo Group n=19 Participants These patients have IBS and are receiving placebo tablets twice a day	Active Group n=25 Participants These patients have IBS and are receiving the rifaximin 550mg twice a day
Change in Bloating	-0.2 units on a scale 95% Confidence Interval 0.2 • Interval -0.7 to 0.3	-0.2 units on a scale 95% Confidence Interval 0.2 • Interval -0.7 to 0.3

Adverse Events

Placebo Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Active Group

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo Group n=27 participants at risk These patients have IBS and are receiving placebo tablets twice a day	Active Group n=27 participants at risk These patients have IBS and are receiving the rifaximin 550mg twice a day
Musculoskeletal and connective tissue disorders accidental Injury	3.7% 1/27 • Number of events 1 • The participants were followed up for 6 months after treatment ended.	11.1% 3/27 • Number of events 3 • The participants were followed up for 6 months after treatment ended.
Gastrointestinal disorders Diarrhea	11.1% 3/27 • Number of events 3 • The participants were followed up for 6 months after treatment ended.	11.1% 3/27 • Number of events 3 • The participants were followed up for 6 months after treatment ended.
Gastrointestinal disorders Bloating	3.7% 1/27 • Number of events 1 • The participants were followed up for 6 months after treatment ended.	7.4% 2/27 • Number of events 2 • The participants were followed up for 6 months after treatment ended.
Infections and infestations Infection	3.7% 1/27 • Number of events 1 • The participants were followed up for 6 months after treatment ended.	11.1% 3/27 • Number of events 3 • The participants were followed up for 6 months after treatment ended.
Nervous system disorders Anxiety	0.00% 0/27 • The participants were followed up for 6 months after treatment ended.	3.7% 1/27 • Number of events 1 • The participants were followed up for 6 months after treatment ended.
Musculoskeletal and connective tissue disorders Myalgia	3.7% 1/27 • Number of events 1 • The participants were followed up for 6 months after treatment ended.	11.1% 3/27 • Number of events 3 • The participants were followed up for 6 months after treatment ended.
Surgical and medical procedures Surgery	3.7% 1/27 • Number of events 1 • The participants were followed up for 6 months after treatment ended.	18.5% 5/27 • Number of events 5 • The participants were followed up for 6 months after treatment ended.
Skin and subcutaneous tissue disorders Body Rash	3.7% 1/27 • Number of events 1 • The participants were followed up for 6 months after treatment ended.	0.00% 0/27 • The participants were followed up for 6 months after treatment ended.
Gastrointestinal disorders Abdominal pain	3.7% 1/27 • Number of events 1 • The participants were followed up for 6 months after treatment ended.	0.00% 0/27 • The participants were followed up for 6 months after treatment ended.

Additional Information

Ashok Tuteja, M.D.

George E. Wahlen V.A. Medical Center, Salt Lake City, UT

Phone: 801-582-1565

Email: ashok.tuteja@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place