Irritable Bowel SyndromeNCT02186743
Irritable Bowel Syndrome and Food Sensitivity
A study testing Personalized Dietary Advice in people with Irritable Bowel Syndrome, run by Yale University at 1 site in United States.
Trial summary
The primary objective of the clinical trial portion of this study is to assess whether an individualized dietary plan based on a commercial food sensitivity assay provides specific benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Personalized Dietary Advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jan 2016
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18-70 years of age.
- Irritable Bowel Syndrome by Rome III criteria.
- Stable dose (30 days) of concurrent IBS medications
- Agree not to make significant changes to their diet during the study
- IBS-SSS score of >150
Who cannot join
- History of major abdominal surgeries
- History of inflammatory bowel disease
- Antibiotic use within 1 month of enrollment
- Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function
- Current use of opioid pain medications (except for NSAIDs)
- Previous experience participating in dietary studies for IBS
Show all 9Show fewer
- Current use of medications which are known to be affected by modest dietary changes
- Vitamin C use of >2000 mg/day
- Quercetin use of >500 mg/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Irritable Bowel Syndrome and Food Sensitivity: Assessing Clinical Outcomes and Inflammatory Cellular Pathways
The primary objective of the clinical trial portion of this study is to assess whether an individualized dietary plan based on a commercial food sensitivity assay provides specific benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS).
Read the detailed description
This is a parallel group, randomized control trial, powered to assess changes in validated outcomes in adult patients with symptomatic irritable bowel syndrome. Subjects will receive dietary counseling and be asked to adhere to dietary instructions for 4 weeks. Assessments will occur at baseline, 4-weeks, and 8-weeks post-baseline.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Personalized Dietary Advice
- Keywords
- Irritable Bowel Syndrome, IBS, Diet, Food sensitivity
- Medical subject headings
- Irritable Bowel Syndrome, Food Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Dietary AdviceOther
Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Diet | Experimental | Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion. Receives: Other: Personalized Dietary Advice |
| Active control diet | Active comparator | Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion. Receives: Other: Personalized Dietary Advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.
Measured: Baseline
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.
Measured: 4 weeks
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.
Measured: 8 weeks
Secondary outcomes (9)
Irritable Bowel Syndrome Adequate Relief (IBS-AR)
The IBS-AR is a single item assessment of IBS symptom relief. It poses the question to study participants "Over the past week have you had adequate relief of your IBS symptoms?" Subjects respond either "yes" or "no."
Measured: Baseline
Irritable Bowel Syndrome Adequate Relief (IBS-AR)
The IBS-AR is a single item assessment of IBS symptom relief. It poses the question to study participants "Over the past week have you had adequate relief of your IBS symptoms?" Subjects respond either "yes" or "no."
Measured: 4 weeks
Irritable Bowel Syndrome Adequate Relief (IBS-AR)
The IBS-AR is a single item assessment of IBS symptom relief. It poses the question to study participants "Over the past week have you had adequate relief of your IBS symptoms?" Subjects respond either "yes" or "no."
Measured: 8 weeks
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
The IBS-SSS contains five questions that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life.
Measured: Baseline
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
The IBS-SSS contains five questions that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life.
Measured: 4 weeks
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
The IBS-SSS contains five questions that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life.
Measured: 8 weeks
Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
The IBS-QoL is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale and a linear transformation yields a summed score with a theoretical range of 0 to 100, with a higher score indicating better quality of life.
Measured: Baseline
Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
The IBS-QoL is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale and a linear transformation yields a summed score with a theoretical range of 0 to 100, with a higher score indicating better quality of life.
Measured: 4 weeks
Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
The IBS-QoL is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale and a linear transformation yields a summed score with a theoretical range of 0 to 100, with a higher score indicating better quality of life.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Cell Science Systems, Corp.
- Responsible party
- Sponsor
- Investigators
- Ather Ali, ND, MPH, MHS, Principal investigator, Yale UniversityWajahat Mehal, MD, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186743
- Sponsor's protocol ID
- 1404013784
- Status last verified
- Jan 2016
- First submitted
- 7 Jul 2014
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ali A, Weiss TR, McKee D, Scherban A, Khan S, Fields MR, Apollo D, Mehal WZ. Efficacy of individualised diets in patients with irritable bowel syndrome: a randomised controlled trial. BMJ Open Gastroenterol. 2017 Sep 20;4(1):e000164. doi: 10.1136/bmjgast-2017-000164. eCollection 2017.
PubMed 29018540
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irritable Bowel Syndrome and Food Sensitivity: Assessing Clinical Outcomes and Inflammatory Cellular Pathways
- ClinicalTrials.gov ID
- NCT02186743
- Acronym / sponsor ID
- 1404013784
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, IBS, Diet, Food sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Cell Science Systems, Corp.
- Study start
- Jul 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Jul 2014 (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.
The primary objective of the clinical trial portion of this study is to assess whether an individualized dietary plan based on a commercial food sensitivity assay provides specific benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS).
Detailed description
This is a parallel group, randomized control trial, powered to assess changes in validated outcomes in adult patients with symptomatic irritable bowel syndrome. Subjects will receive dietary counseling and be asked to adhere to dietary instructions for 4 weeks. Assessments will occur at baseline, 4-weeks, and 8-weeks post-baseline.
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 |
|---|---|---|
| Intervention Diet | Experimental | Other: Personalized Dietary AdvicePersonalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion. |
| Active control diet | Active comparator | Other: Personalized Dietary AdvicePersonalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between 18-70 years of age.
- Irritable Bowel Syndrome by Rome III criteria.
- Stable dose (30 days) of concurrent IBS medications
- Agree not to make significant changes to their diet during the study
- IBS-SSS score of >150
Key exclusion criteria (9 listed)
- History of major abdominal surgeries
- History of inflammatory bowel disease
- Antibiotic use within 1 month of enrollment
- Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function
- Current use of opioid pain medications (except for NSAIDs)
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 |
|---|---|---|
| Personalized Dietary AdvicePersonalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion. | Other | Active control diet, Intervention Diet |
Primary outcome
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
Time frame: Baseline
The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
Time frame: 4 weeks
The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)
Time frame: 8 weeks
The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.
9 secondary outcomes
Irritable Bowel Syndrome Adequate Relief (IBS-AR)
Time frame: Baseline
Irritable Bowel Syndrome Adequate Relief (IBS-AR)
Time frame: 4 weeks
Irritable Bowel Syndrome Adequate Relief (IBS-AR)
Time frame: 8 weeks
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Time frame: Baseline
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Time frame: 4 weeks
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Time frame: 8 weeks
Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
Time frame: Baseline
Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
Time frame: 4 weeks
Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)
Time frame: 8 weeks
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 18 Oct 2017.
- Results publication: PubMed 29018540Ali A, Weiss TR, McKee D, Scherban A, Khan S, Fields MR, Apollo D, Mehal WZ. Efficacy of individualised diets in patients with irritable bowel syndrome: a randomised controlled trial. BMJ Open Gastroenterol. 2017 Sep 20;4(1):e000164. doi: 10.1136/bmjgast-2017-000164. eCollection 2017.
- BMJ Open GastroenterologyLink provided by the sponsor.
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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.
Ather Ali, ND, MPH, MHS principal investigator
Yale University
Wajahat Mehal, MD, PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Dietary Advice in people with Irritable Bowel Syndrome, run by Yale University 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 5 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 18 Oct 2017. 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?
Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02186743, which also lists 1 linked publication.
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 18 Oct 2017.