Irritable Bowel SyndromeNCT02881944
Effect of Diet on Gulf War Illness
A study testing Low FODMAP Diet and High FODMAP Diet in people with Irritable Bowel Syndrome, run by Ashok Tuteja at 1 site in United States.
Trial summary
Fermentable Oligo-, Di and Mono-saccharides And Polyols (FODMAPs) are carbohydrates that are poorly digested in intestines. The undigested carbohydrates are fermented in the colon by gut bacteria. Fermentation of these carbohydrates can lead to diarrhea, gas and distension of the colon. Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Low FODMAP Diet and High FODMAP Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gulf War Veterans
- Men and women age 25-90 years
- Gulf War Illness: Veterans will have Rome III criteria for IBS and two or more of the non-intestinal symptom groups (chronic-once a week or more often-fatigue, insomnia, joint pains, general stiffness, and headache, neurological an mood, respirator and skin symptoms)
- Symptoms of > 6 months duration
- No significant findings on physical examination, complete blood count and clinical chemistry panel
- Normal gross appearance of the colonic mucosa (small colon polyps not an exclusion criteria)
- Veterans with psychological disorders will not be excluded but will be identified for sub-group analysis.
Who cannot join
- Current evidence of any lower gastrointestinal disorder such as celiac disease or inflammatory bowel disease
- Clinically significant chronic disease: HIV, cardiac, pulmonary, hepatic or renal dysfunction
- Presence of Giardia antigen, and Clostridium difficile toxin in stool
- Current history of drug or alcohol abuse
- Investigator perception of patient's inability to comply with study protocol
- Recent change in gastrointestinal medications
- Subject is currently participating in another research protocol. These subjects will be allowed to enroll after a washout period of one month.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
George E Wahlen VA Medical Center
Salt Lake City, Utah, 84132
Ashok K Tuteja, MD, MPH, 801-582-1565 ext. 4019, ashok.tuteja@va.gov
Jaya Vijayan, 801-581-7802, jaya.vijayan@hsc.utah.edu
About this study
Fermentable Oligo-, Di and Mono-saccharides And Polyols (FODMAPs) are carbohydrates that are poorly digested in intestines. The undigested carbohydrates are fermented in the colon by gut bacteria. Fermentation of these carbohydrates can lead to diarrhea, gas and distension of the colon. Low FODMAP diet effect may be mediated by changing the gut bacteria and/or by production of chemicals that influence Veteran's intestines which then result in reduced disease symptoms.
The goal of this study is to compare a low FODMAP (modified healthy) diet to a high FODMAP (typical healthy) diet for effect on Veterans with IBS and symptoms of Gulf War illness.
Read the detailed description
Study Design This will be a prospective, blinded randomized clinical trial with two parallel groups. There will be 1-week screening period, 3-week diet treatment and, follow-up one month later while Veterans choose their own diet.
Veterans who were deployed and served in Operation Desert Storm and Desert Shield will be recruited to participate.
The two study diets to be provided to the Veterans and compared are:
Low FODMAP (modified healthy) diet:
High FODMAP (typical healthy) diet:
The FODMAP content of this diet will be higher than low FODMAP diet.
All questionnaires will be answered and measurements performed at baseline, end of treatment and at follow-up visits.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Low FODMAP Diet, High FODMAP Diet
- Keywords
- Gulf War Illness, Diet, IBS, FODMAP
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low FODMAP DietBehavioural
Diet low in foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols
High FODMAP DietBehavioural
Typical diet of foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols
| Study group | Role | What they receive |
|---|---|---|
| Low FODMAP (modified healthy) Diet | Experimental | Low FODMAP diet for 3 weeks. Veterans will be provided a diet containing foods low in FODMAP. Receives: Behavioral: Low FODMAP Diet |
| High FODMAP (typical healthy) Diet | Experimental | High FODMAP diet for 3 weeks. Veterans will be provided a typically healthy diet following US Dietary Guidelines, containing foods high in FODMAPs Receives: Behavioral: High FODMAP Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported global Bowel Symptom Score
Change in bowel symptom score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet.
Measured: Baseline and 3 Weeks
Secondary outcomes (1)
Change in self-reported Irritable Bowel Syndrome Quality of Life (IBS-QOL) score
Change in IBS-QOL score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet.
Measured: Baseline and 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ashok Tuteja
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor-investigator, Ashok Tuteja, VA Salt Lake City Health Care System
- Investigators
- Ashok K Tuteja, M.D., Principal investigator, George E. Wahlen VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881944
- Sponsor's protocol ID
- IRB_00087668
- Status last verified
- Jan 2018
- First submitted
- 24 Aug 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Diet on Gulf War Illness
- ClinicalTrials.gov ID
- NCT02881944
- Acronym / sponsor ID
- IRB_00087668
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Gulf War Illness, Diet, IBS, FODMAP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ashok TutejaUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- Aug 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fermentable Oligo-, Di and Mono-saccharides And Polyols (FODMAPs) are carbohydrates that are poorly digested in intestines. The undigested carbohydrates are fermented in the colon by gut bacteria. Fermentation of these carbohydrates can lead to diarrhea, gas and distension of the colon. Low FODMAP diet effect may be mediated by changing the gut bacteria and/or by production of chemicals that influence Veteran's intestines which then result in reduced disease symptoms.
The goal of this study is to compare a low FODMAP (modified healthy) diet to a high FODMAP (typical healthy) diet for effect on Veterans with IBS and symptoms of Gulf War illness.
Detailed description
Study Design This will be a prospective, blinded randomized clinical trial with two parallel groups. There will be 1-week screening period, 3-week diet treatment and, follow-up one month later while Veterans choose their own diet.
Veterans who were deployed and served in Operation Desert Storm and Desert Shield will be recruited to participate.
The two study diets to be provided to the Veterans and compared are:
Low FODMAP (modified healthy) diet:
High FODMAP (typical healthy) diet:
The FODMAP content of this diet will be higher than low FODMAP diet.
All questionnaires will be answered and measurements performed at baseline, end of treatment and at follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low FODMAP (modified healthy) Diet | Experimental | Behavioral: Low FODMAP DietLow FODMAP diet for 3 weeks. Veterans will be provided a diet containing foods low in FODMAP. |
| High FODMAP (typical healthy) Diet | Experimental | Behavioral: High FODMAP DietHigh FODMAP diet for 3 weeks. Veterans will be provided a typically healthy diet following US Dietary Guidelines, containing foods high in FODMAPs |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Gulf War Veterans
- Men and women age 25-90 years
- Gulf War Illness: Veterans will have Rome III criteria for IBS and two or more of the non-intestinal symptom groups (chronic-once a week or more often-fatigue, insomnia, joint pains, general stiffness, and headache, neurological an mood, respirator and skin symptoms)
- Symptoms of > 6 months duration
- No significant findings on physical examination, complete blood count and clinical chemistry panel
Key exclusion criteria (7 listed)
- Current evidence of any lower gastrointestinal disorder such as celiac disease or inflammatory bowel disease
- Clinically significant chronic disease: HIV, cardiac, pulmonary, hepatic or renal dysfunction
- Presence of Giardia antigen, and Clostridium difficile toxin in stool
- Current history of drug or alcohol abuse
- Investigator perception of patient's 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 |
|---|---|---|
| Low FODMAP DietDiet low in foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols | Behavioural | Low FODMAP (modified healthy) Diet |
| High FODMAP DietTypical diet of foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols | Behavioural | High FODMAP (typical healthy) Diet |
Primary outcome
Change in self-reported global Bowel Symptom Score
Time frame: Baseline and 3 Weeks
Change in bowel symptom score after 3 weeks of treatment with a Low FODMAP diet or High FODMAP diet.
1 secondary outcome
Change in self-reported Irritable Bowel Syndrome Quality of Life (IBS-QOL) score
Time frame: Baseline and 3 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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, M.D. principal investigator
George E. Wahlen VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low FODMAP Diet and High FODMAP Diet in people with Irritable Bowel Syndrome, run by Ashok Tuteja 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Feb 2018. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaya Vijayan, MBBS (801-582-1565 ext. 4019, jaya.vijayan@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported global Bowel Symptom Score (time frame: Baseline and 3 Weeks). 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 1 Feb 2018.