Trial · NCT00680836
Gulf War Digestive Health Study
NCT00680836, Not applicable, Completed, US Department of Veterans Affairs; results first posted 2014-08-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gulf War Digestive Health Study. Trials, record NCT00680836. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00680836
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gulf War Digestive Health Study
- NCT number
- NCT00680836
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 54 participants, actual
- Lead sponsor
- US Department of Veterans Affairs
- Conditions
- Irritable Bowel Syndrome, Small Intestinal Bacterial Overgrowth
- Interventions
- Placebo, Rifaximin
- First posted
- 2008-05-20
- Last updated
- 2014-08-29
- Results first posted
- 2014-08-29
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Global Improvement Scale | 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. |
| Secondary | Change in Stool Frequency (Number of Bowel Movements Per Day) | 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. |
| Secondary | Change in Stool Consistency | 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. |
| Secondary | Change in Bowel Urgency | 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. |
| Secondary | Change in Abdominal Pain With Bowel Movement | 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. |
| Secondary | Change in Bloating | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Global Improvement Scale | Measured for seven days at the end of 2 weeks treatment and average score is calculated | units on a scale | MEAN | |
| SECONDARY | Change in Stool Frequency (Number of Bowel Movements Per Day) | 2 weeks | Bowel movements/ day | MEAN | |
| SECONDARY | Change in Stool Consistency | 2 weeks | units on a scale (BSS) | MEAN | |
| SECONDARY | Change in Bowel Urgency | 2 weeks | difference in percentage of 'Yes' | MEAN | |
| SECONDARY | Change in Abdominal Pain With Bowel Movement | 2 weeks | units on a scale | MEAN | |
| SECONDARY | Change in Bloating | 2 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Global Improvement Scale | Placebo Group | 4.3 | Standard Deviation 1.0 | units on a scale | |
| Global Improvement Scale | Active Group | 4.3 | Standard Deviation 0.9 | units on a scale | |
| Change in Stool Frequency (Number of Bowel Movements Per Day) | Placebo Group | -0.3 | 95% Confidence Interval -0.7 to 0.2 | Bowel movements/ day | |
| Change in Stool Frequency (Number of Bowel Movements Per Day) | Active Group | -0.1 | 95% Confidence Interval 0.2 | Bowel movements/ day | |
| Change in Stool Consistency | Placebo Group | -0.4 | 95% Confidence Interval 0.2 | units on a scale (BSS) | |
| Change in Stool Consistency | Active Group | -0.3 | 95% Confidence Interval 0.2 | units on a scale (BSS) | |
| Change in Bowel Urgency | Placebo Group | 0.0 | 95% Confidence Interval 0.1 | difference in percentage of 'Yes' | |
| Change in Bowel Urgency | Active Group | -0.1 | 95% Confidence Interval 0.1 | difference in percentage of 'Yes' | |
| Change in Abdominal Pain With Bowel Movement | Placebo Group | -0.3 | 95% Confidence Interval 0.2 | units on a scale | |
| Change in Abdominal Pain With Bowel Movement | Active Group | -0.2 | 95% Confidence Interval 0.2 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Group | 27 | |
| Overall Study | STARTED | Active Group | 27 | |
| Overall Study | COMPLETED | Placebo Group | 19 | |
| Overall Study | COMPLETED | Active Group | 25 | |
| Overall Study | NOT COMPLETED | Placebo Group | 8 | |
| Overall Study | NOT COMPLETED | Active Group | 2 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | accidental Injury | Musculoskeletal and connective tissue disorders | Placebo Group | 1 | 27 | 1 |
| other | accidental Injury | Musculoskeletal and connective tissue disorders | Active Group | 3 | 27 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Placebo Group | 3 | 27 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Active Group | 3 | 27 | 3 |
| other | Bloating | Gastrointestinal disorders | Placebo Group | 1 | 27 | 1 |
| other | Bloating | Gastrointestinal disorders | Active Group | 2 | 27 | 2 |
| other | Infection | Infections and infestations | Placebo Group | 1 | 27 | 1 |
| other | Infection | Infections and infestations | Active Group | 3 | 27 | 3 |
| other | Anxiety | Nervous system disorders | Placebo Group | 0 | 27 | 0 |
| other | Anxiety | Nervous system disorders | Active Group | 1 | 27 | 1 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Group | ||
| Total, all-cause mortality | Active Group | ||
| Total, other adverse events | Placebo Group | 10 | 27 |
| Total, other adverse events | Active Group | 14 | 27 |
| Total, serious adverse events | Placebo Group | 0 | 27 |
| Total, serious adverse events | Active Group | 0 | 27 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Active Group vs Placebo Group: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00680836
GET https://conductscience.org/api/trials/v1/NCT00680836/registered