Irritable Bowel SyndromeNCT00680836
Gulf War Digestive Health Study
A study testing Rifaximin in people with Irritable Bowel Syndrome and Small Intestinal Bacterial Overgrowth, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purposes of this study are to estimate the burden of disease due to chronic gastrointestinal illness in PG veterans, to evaluate whether Small Bowel Bacterial Overgrowth (SBBO) is associated with chronic diarrhea in PG veterans, and to determine whether eradication of SBBO reduces symptoms of chronic diarrhea… Read more about this study
- Who is it for?
- Ages 35 to 72 years
- Conditions the study is for
- Irritable Bowel Syndrome, Small Intestinal Bacterial Overgrowth
- What is being tested?
- Rifaximin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 32-75 years
- Rome III criteria for diarrhea-predominant IBS
- Symptom onset after an apparent episode of acute gastroenteritis
- Symptoms of > 3 months duration
- Normal endoscopic appearance of the colonic mucosa
- Negative markers for celiac disease and inflammatory bowel disease.
- Normal thyroid function and serum calcium levels.
- Must have served in the military or reserves during the time of Operation Desert Storm (August 1990 to May 1991)
Who cannot join
- Clinically significant cardiac, pulmonary, hepatic or renal dysfunction
- History of/or presence of systemic malignancy
- Current evidence of any gastrointestinal disorder such as celiac disease or inflammatory bowel disease (i.e. Crohns disease or ulcerative colitis)
- Current effects of drug or alcohol abuse
- Investigator perception of patients inability to comply with study protocol
- Unstable psychiatric disease
Show all 9Show fewer
- Recent change in gastrointestinal medications
- Subjects with a positive pregnancy test
- Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Epidemiology
Salt Lake City, Utah, 84132
About this study
Official title: Diarrhea-Predominant Irritable Bowel Syndrome in Persian Gulf Veterans
The purposes of this study are to estimate the burden of disease due to chronic gastrointestinal illness in PG veterans, to evaluate whether Small Bowel Bacterial Overgrowth (SBBO) is associated with chronic diarrhea in PG veterans, and to determine whether eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and bloating in PG veterans.
Read the detailed description
Approximately 700,000 United States military personnel were deployed in the first Persian Gulf (PG) War. Several months after their return, up to 25% of Veterans had persistent symptoms which they suspected were related to their military service in the Gulf. Among the most frequent were gastrointestinal symptoms such as loose stools, excessive gas and abdominal pain. These symptoms are typical of diarrhea-predominant irritable bowel syndrome (IBS).
The cause of IBS is not known; speculated mechanisms include altered GI motility, bacterial overgrowth, visceral hypersensitivity and psychological stress. Another proposed mechanism relates to the fact that up to one third of patients with IBS describe the onset of their symptoms following acute gastroenteritis. This is called post-infective IBS (PI-IBS). How acute gastroenteritis leads to persistent GI symptoms of IBS is not known. A limited amount of data suggests that patients with IBS may have an imbalance in their gastrointestinal microflora. Several studies indicate that small bowel bacterial overgrowth is more common in individuals with IBS. Symptoms of SBBO are similar to diarrhea-predominant IBS and include chronic diarrhea, bloating and abdominal pain.
More than 50 percent of military personnel developed acute gastroenteritis while on duty in the Gulf. Most of them who reported symptoms of IBS had an acute onset which occurred in association with an episode of acute gastroenteritis during their tour of duty. Other travelers are known to be colonized by new micro-organisms during travel to foreign countries. This acquisition is thought to be related to a change in diet. The natural history of this change in bowel flora, in part, depends on host factors and can persist for months after travel abroad. It seems likely, that PG veterans with persistent diarrhea and a negative work-up for known GI diseases have PI-IBS. No study in the past has evaluated the role of SBBO in causing chronic GI symptoms in PG Veterans. Furthermore, soldiers involved in combat are exposed to a highly stressful environment, perhaps making them more susceptible to persistent symptoms.
We hypothesize that PG veterans with chronic GI symptoms have symptoms of diarrhea predominant IBS and this is caused by SBBO due to a change in microflora during deployment in the Persian Gulf and that it is predisposed to by the stress of combat. Intestinal microflora, once altered, is known to be relatively stable; once mucosal damage occurs it may become permanent.
Objectives Objective # 1: Estimate the burden of disease due to chronic gastrointestinal illness in PG veterans.
Hypothesis:
- The prevalence of GI symptoms is high in PG veterans. ii. The prevalence of IBS is higher in veterans who report acute gastroenteritis during the period of deployment. iii. PG Veterans with IBS have a lower IBS related QOL
Objective # 2: Evaluate whether SBBO is associated with chronic diarrhea in PG veterans.
Hypothesis i. SBBO is more common in PG veterans than non deployed veterans. ii. SBBO is more common in PG veterans with diarrhea-predominant IBS vs. those without.
Objective: # 3: Determine whether eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and bloating in PG Veterans.
Hypothesis:
- Treatment with rifaximin, a non-absorbable antibiotic, will improve symptoms and QOL in Veterans with SBBO.
- Being tested
- Placebo, Rifaximin
- Keywords
- Irritable Bowel Syndrome, Diarrhea, Gulf War, Veterans, Small intestinal bacterial overgrowth (SIBO)
- Medical subject headings
- Irritable Bowel Syndrome, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Inactive pill
orally two times per day for 14 days
RifaximinDrug
Also called Xifaxan
550 mg orally two times per day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Active comparator | These patients have IBS and are receiving the rifaximin. Receives: Drug: Rifaximin |
| Placebo group | Placebo comparator | These patients have IBS and are receiving the placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Improvement Scale
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.
Measured: Measured for seven days at the end of 2 weeks treatment and average score is calculated
Secondary outcomes (5)
Change in Stool Frequency (Number of Bowel Movements Per Day)
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.
Measured: 2 weeks
Change in Stool Consistency
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.
Measured: 2 weeks
Change in Bowel Urgency
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.
Measured: 2 weeks
Change in Abdominal Pain With Bowel Movement
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.
Measured: 2 weeks
Change in Bloating
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2008
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ashok K Tuteja, MD MPH, Principal investigator, Division of Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680836
- Sponsor's protocol ID
- GWRA-014-05F
- Status last verified
- Aug 2014
- First submitted
- 16 May 2008
- Last updated
- 29 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diarrhea-Predominant Irritable Bowel Syndrome in Persian Gulf Veterans
- ClinicalTrials.gov ID
- NCT00680836
- Acronym / sponsor ID
- GWRA-014-05F
- Keywords
- Irritable Bowel Syndrome, Diarrhea, Gulf War, Veterans, Small intestinal bacterial overgrowth (SIBO)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 May 2008 (estimated)
- Results
- Posted 29 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are to estimate the burden of disease due to chronic gastrointestinal illness in PG veterans, to evaluate whether Small Bowel Bacterial Overgrowth (SBBO) is associated with chronic diarrhea in PG veterans, and to determine whether eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and bloating in PG veterans.
Detailed description
Approximately 700,000 United States military personnel were deployed in the first Persian Gulf (PG) War. Several months after their return, up to 25% of Veterans had persistent symptoms which they suspected were related to their military service in the Gulf. Among the most frequent were gastrointestinal symptoms such as loose stools, excessive gas and abdominal pain. These symptoms are typical of diarrhea-predominant irritable bowel syndrome (IBS).
The cause of IBS is not known; speculated mechanisms include altered GI motility, bacterial overgrowth, visceral hypersensitivity and psychological stress. Another proposed mechanism relates to the fact that up to one third of patients with IBS describe the onset of their symptoms following acute gastroenteritis. This is called post-infective IBS (PI-IBS). How acute gastroenteritis leads to persistent GI symptoms of IBS is not known. A limited amount of data suggests that patients with IBS may have an imbalance in their gastrointestinal microflora. Several studies indicate that small bowel bacterial overgrowth is more common in individuals with IBS. Symptoms of SBBO are similar to diarrhea-predominant IBS and include chronic diarrhea, bloating and abdominal pain.
More than 50 percent of military personnel developed acute gastroenteritis while on duty in the Gulf. Most of them who reported symptoms of IBS had an acute onset which occurred in association with an episode of acute gastroenteritis during their tour of duty. Other travelers are known to be colonized by new micro-organisms during travel to foreign countries. This acquisition is thought to be related to a change in diet. The natural history of this change in bowel flora, in part, depends on host factors and can persist for months after travel abroad. It seems likely, that PG veterans with persistent diarrhea and a negative work-up for known GI diseases have PI-IBS. No study in the past has evaluated the role of SBBO in causing chronic GI symptoms in PG Veterans. Furthermore, soldiers involved in combat are exposed to a highly stressful environment, perhaps making them more susceptible to persistent symptoms.
We hypothesize that PG veterans with chronic GI symptoms have symptoms of diarrhea predominant IBS and this is caused by SBBO due to a change in microflora during deployment in the Persian Gulf and that it is predisposed to by the stress of combat. Intestinal microflora, once altered, is known to be relatively stable; once mucosal damage occurs it may become permanent.
Objectives Objective # 1: Estimate the burden of disease due to chronic gastrointestinal illness in PG veterans.
Hypothesis:
- The prevalence of GI symptoms is high in PG veterans. ii. The prevalence of IBS is higher in veterans who report acute gastroenteritis during the period of deployment. iii. PG Veterans with IBS have a lower IBS related QOL
Objective # 2: Evaluate whether SBBO is associated with chronic diarrhea in PG veterans.
Hypothesis i. SBBO is more common in PG veterans than non deployed veterans. ii. SBBO is more common in PG veterans with diarrhea-predominant IBS vs. those without.
Objective: # 3: Determine whether eradication of SBBO reduces symptoms of chronic diarrhea, abdominal pain and bloating in PG Veterans.
Hypothesis:
- Treatment with rifaximin, a non-absorbable antibiotic, will improve symptoms and QOL in Veterans with SBBO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Active comparator | Drug: RifaximinThese patients have IBS and are receiving the rifaximin. |
| Placebo group | Placebo comparator | Drug: PlaceboThese patients have IBS and are receiving the placebo. |
Who may qualify
- Ages
- 35 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women age 32-75 years
- Rome III criteria for diarrhea-predominant IBS
- Symptom onset after an apparent episode of acute gastroenteritis
- Symptoms of > 3 months duration
- Normal endoscopic appearance of the colonic mucosa
Key exclusion criteria (9 listed)
- Clinically significant cardiac, pulmonary, hepatic or renal dysfunction
- History of/or presence of systemic malignancy
- Current evidence of any gastrointestinal disorder such as celiac disease or inflammatory bowel disease (i.e. Crohns disease or ulcerative colitis)
- Current effects of drug or alcohol abuse
- Investigator perception of patients inability to comply with study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Inactive pillorally two times per day for 14 days | Drug | Placebo group |
| RifaximinAlso: Xifaxan550 mg orally two times per day for 14 days | Drug | Treatment Group |
Primary outcome
Global Improvement Scale
Time frame: 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.
5 secondary outcomes
Change in Stool Frequency (Number of Bowel Movements Per Day)
Time frame: 2 weeks
Change in Stool Consistency
Time frame: 2 weeks
Change in Bowel Urgency
Time frame: 2 weeks
Change in Abdominal Pain With Bowel Movement
Time frame: 2 weeks
Change in Bloating
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashok K Tuteja, MD MPH principal investigator
Division of Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifaximin in people with Irritable Bowel Syndrome and Small Intestinal Bacterial Overgrowth, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Improvement Scale (time frame: Measured for seven days at the end of 2 weeks treatment and average score is calculated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2014.