IBS - Irritable Bowel SyndromeNCT03948854
Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients
A study testing Registered dietitian, On-line video program and Printed handout in people with IBS - Irritable Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are trying to determine the best course of action regarding the dietary management with a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP diet) for irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Registered dietitian, On-line video program and Printed handout
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2019to 19 Feb 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult subjects (18-75 years) seen in the primary care clinic or in the Gastroenterology clinic at Mayo Clinic Florida, who are diagnosed with IBS by Rome IV criteria
Who cannot join
- Subjects who have previously tried the low FODMAP diet (whether successful or not)
- Current or recent (less than 4 weeks) opioid use
- Current or recent (less than 10 weeks) rifaximin use
- Inability to speak or read English
- Pregnancy and/or breast-feeding
- Medical or psychological issues that would prevent modifying their diet for 8 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients: Which Educational Method Works Best
Researchers are trying to determine the best course of action regarding the dietary management with a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP diet) for irritable bowel syndrome.
Read the detailed description
An analysis of different educational programs providing information on the low FODMAP diet will be performed.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Registered dietitian, On-line video program, Printed handout, Dietitian-led group
- 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.
Registered dietitianOther
Education on low FODMAP diet is provided in person by a registered dietitian who is an expert on the low FODMAP diet
On-line video programOther
Education on low FODMAP diet is provided by an on-line program via a link sent through email
Printed handoutOther
Education on low FODMAP diet is provided through printed handout material at the initial visit.
Dietitian-led groupOther
Education on low FODMAP diet is provided in a dietitian-led group setting
| Study group | Role | What they receive |
|---|---|---|
| Registered dietitian education | Experimental | Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in person by a registered dietitian Receives: Other: Registered dietitian |
| On-line video program education | Experimental | Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet using an on-line video program Receives: Other: On-line video program |
| Handout education | Experimental | Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet by a printed handout Receives: Other: Printed handout |
| Dietitian-led group education | Experimental | Subjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in a dietitian-led group setting Receives: Other: Dietitian-led group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in IBS symptoms
Change in IBS symptoms will be measured from baseline to the end of study using the validated IBS symptoms severity scale (IBS-SS). This is a visual analog scale from 0-100. The primary outcome measure is improvement in symptom scores from end of study to baseline.
Measured: Baseline, end of study approximately 8 to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start22 May 2019
- Primary completion19 Feb 2022
- Study completion19 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian E. Lacy, Mayo Clinic
- Investigators
- Brian Lacy, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948854
- Sponsor's protocol ID
- 18-011391
- Status last verified
- Dec 2022
- First submitted
- 10 May 2019
- Last updated
- 14 Dec 2022
- 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 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients: Which Educational Method Works Best
- ClinicalTrials.gov ID
- NCT03948854
- Acronym / sponsor ID
- 18-011391
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 19 Feb 2022 (actual)
- Study completion
- 19 Feb 2022 (actual)
- First posted
- 14 May 2019 (actual)
- 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.
Researchers are trying to determine the best course of action regarding the dietary management with a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP diet) for irritable bowel syndrome.
Detailed description
An analysis of different educational programs providing information on the low FODMAP diet will be performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Registered dietitian education | Experimental | Other: Registered dietitianSubjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in person by a registered dietitian |
| On-line video program education | Experimental | Other: On-line video programSubjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet using an on-line video program |
| Handout education | Experimental | Other: Printed handoutSubjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet by a printed handout |
| Dietitian-led group education | Experimental | Other: Dietitian-led groupSubjects with irritable bowel syndrome (IBS) will receive education on FODMAP diet in a dietitian-led group setting |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult subjects (18-75 years) seen in the primary care clinic or in the Gastroenterology clinic at Mayo Clinic Florida, who are diagnosed with IBS by Rome IV criteria
Key exclusion criteria (6 listed)
- Subjects who have previously tried the low FODMAP diet (whether successful or not)
- Current or recent (less than 4 weeks) opioid use
- Current or recent (less than 10 weeks) rifaximin use
- Inability to speak or read English
- Pregnancy and/or breast-feeding
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 |
|---|---|---|
| Registered dietitianEducation on low FODMAP diet is provided in person by a registered dietitian who is an expert on the low FODMAP diet | Other | Registered dietitian education |
| On-line video programEducation on low FODMAP diet is provided by an on-line program via a link sent through email | Other | On-line video program education |
| Printed handoutEducation on low FODMAP diet is provided through printed handout material at the initial visit. | Other | Handout education |
| Dietitian-led groupEducation on low FODMAP diet is provided in a dietitian-led group setting | Other | Dietitian-led group education |
Primary outcome
Improvement in IBS symptoms
Time frame: Baseline, end of study approximately 8 to 10 weeks
Change in IBS symptoms will be measured from baseline to the end of study using the validated IBS symptoms severity scale (IBS-SS). This is a visual analog scale from 0-100. The primary outcome measure is improvement in symptom scores from end of study to baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Brian Lacy, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Registered dietitian, On-line video program and Printed handout in people with IBS - Irritable Bowel Syndrome, run by Mayo Clinic 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 1 inclusion and 6 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 14 Dec 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in IBS symptoms (time frame: Baseline, end of study approximately 8 to 10 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 14 Dec 2022.