Irritable Bowel SyndromeNCT05831306
A Clinical Trial Evaluating Diets for IBS
A study testing Diet A and Diet B in people with Irritable Bowel Syndrome, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
Diet and lifestyle changes are the recommended first line treatments for symptom relief in irritable bowel syndrome (IBS). Currently the only diet that is widely recommended and for which there is good evidence of efficacy in IBS is one low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Diet A and Diet B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Jul 2021to 31 Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with IBS-D diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, family history of inflammatory bowel disease or celiac disease)
- Aged 18-65 years at the time of screening
- Weekly average of worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0- to-10 point scale
- At least 80% compliance in daily diary entries during the 7-day screening period
Who cannot join
- Subjects adhering to a dietary IBS-treatments such as the low-fat diet, low FODMAP diet, or gluten-free diet within the past 6 months
- Subjects with a known food allergy to eggs, peanuts, or milk (subjects with lactose intolerance who are experiencing IBS symptoms while on a lactose-free diet will not be excluded from the study).
- Subjects with a history of insulin-dependent or non-insulin-dependent diabetes
- Subjects with a known history of celiac disease, inflammatory bowel disease or microscopic colitis
- Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
- BMI < 18.5
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
University of Michigan - Ann Arbor
Ann Arbor, Michigan, 48109
Prashant Singh, MD, singhpr@med.umich.edu
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Samantha Proctor, sprocto1@bidmc.harvard.edu
About this study
Official title: A Randomized Clinical Trial Evaluating Two Different Diets for IBS
Diet and lifestyle changes are the recommended first line treatments for symptom relief in irritable bowel syndrome (IBS). Currently the only diet that is widely recommended and for which there is good evidence of efficacy in IBS is one low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (low-FODMAP). While effective, the Low-FODMAP diet is burdensome and costly to patients and in clinical practice adherence to FODMAP restriction is less than optimal. Further, patients who respond to a FODMAP restriction often are reluctant to reintroduce more FODMAPs into their diet, which may deprive them of foods, particularly fruits and vegetables with important health benefits. Therefore, there is a need for other dietary interventions for IBS that are less burdensome to patients. This clinical trial assesses the efficacy of two dietary interventions.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Diet A, Diet B
- Keywords
- dietary intervention, lifestyle intervention
- 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.
Diet AOther
Modified Diet A
Diet BOther
Modified Diet B
| Study group | Role | What they receive |
|---|---|---|
| Diet A | Experimental | Modified Diet A Receives: Other: Diet A |
| Diet B | Experimental | Modified Diet B Receives: Other: Diet B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Pain Intensity
Proportion of weekly responders. A weekly responder is defined as a decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline.
Measured: 28 days
Secondary outcomes (7)
Abdominal Discomfort Intensity
Proportion of weekly responders. A weekly responder is defined as a decrease in worst abdominal discomfort in the past 24 hours score of at least 30% compared with baseline.
Measured: 28 days
Composite Score
Proportion of weekly composite responders. A weekly composite responder is defined as a subject who experiences a decrease in the weekly average of worst abdominal pain in the 24 hours score of at least 30% compared with baseline AND who experiences a 50% or greater reduction in the number of days per week with at least one stool that has a consistency of Type 6 or 7 compared with baseline
Measured: 28 days
Abdominal Bloating Intensity
Proportion of weekly responders. A weekly responder is defined as a decrease in worst abdominal bloating in the past 24 hours score of at least 30% compared with baseline.
Measured: 28 days
Stool Consistency
Weekly responder. A weekly responder is defined as a decrease of at least 50% in the number of days per week with at least one stool that has a consistency of Bristol Stool Form Scale Type 6 or Type 7 compared with baseline.
Measured: 28 days
Irritable Bowel Syndrome - Symptom Severity Score
Proportion of subjects who experience a 50-point and 100-point decrease in IBS-SSS compared with baseline.
Measured: 28 days
Irritable Bowel Syndrome - Symptom Severity Score
Change in IBS-SSS as compared with baseline.
Measured: 28 days
Adequate Relief
Proportion of subjects who experience adequate relief compared with baseline.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start21 Jul 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
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 Beth Israel Deaconess Medical CenterThe 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, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831306
- Sponsor's protocol ID
- 2020P000625
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh P, Chey SW, Nee J, Eswaran S; Dietary Therapy in IBS Working Group; Lembo A, Chey WD. Is a Simplified, Less Restrictive Low FODMAP Diet Possible? Results From a Double-Blind, Pilot Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2025 Feb;23(2):362-364.e2. doi: 10.1016/j.cgh.2024.04.021. Epub 2024 May 9.
PubMed 38729393
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Evaluating Two Different Diets for IBS
- ClinicalTrials.gov ID
- NCT05831306
- Acronym / sponsor ID
- 2020P000625
- Conditions
- Irritable Bowel Syndrome
- Keywords
- dietary intervention, lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Apr 2023 (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.
Diet and lifestyle changes are the recommended first line treatments for symptom relief in irritable bowel syndrome (IBS). Currently the only diet that is widely recommended and for which there is good evidence of efficacy in IBS is one low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (low-FODMAP). While effective, the Low-FODMAP diet is burdensome and costly to patients and in clinical practice adherence to FODMAP restriction is less than optimal. Further, patients who respond to a FODMAP restriction often are reluctant to reintroduce more FODMAPs into their diet, which may deprive them of foods, particularly fruits and vegetables with important health benefits. Therefore, there is a need for other dietary interventions for IBS that are less burdensome to patients. This clinical trial assesses the efficacy of two dietary interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet A | Experimental | Other: Diet AModified Diet A |
| Diet B | Experimental | Other: Diet BModified Diet B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with IBS-D diagnosed per Rome IV questionnaire and without any unexplained alarm features (rectal bleeding, weight loss, nocturnal symptoms, family history of inflammatory bowel disease or celiac disease)
- Aged 18-65 years at the time of screening
- Weekly average of worst daily (in the past 24 hours) abdominal pain score of ≥3.0 on a 0- to-10 point scale
- At least 80% compliance in daily diary entries during the 7-day screening period
Key exclusion criteria (6 listed)
- Subjects adhering to a dietary IBS-treatments such as the low-fat diet, low FODMAP diet, or gluten-free diet within the past 6 months
- Subjects with a known food allergy to eggs, peanuts, or milk (subjects with lactose intolerance who are experiencing IBS symptoms while on a lactose-free diet will not be excluded from the study).
- Subjects with a history of insulin-dependent or non-insulin-dependent diabetes
- Subjects with a known history of celiac disease, inflammatory bowel disease or microscopic colitis
- Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
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 |
|---|---|---|
| Diet AModified Diet A | Other | Diet A |
| Diet BModified Diet B | Other | Diet B |
Primary outcome
Abdominal Pain Intensity
Time frame: 28 days
Proportion of weekly responders. A weekly responder is defined as a decrease in weekly average of worst abdominal pain in the past 24 hours score of at least 30% compared with baseline.
7 secondary outcomes
Abdominal Discomfort Intensity
Time frame: 28 days
Composite Score
Time frame: 28 days
Abdominal Bloating Intensity
Time frame: 28 days
Stool Consistency
Time frame: 28 days
Irritable Bowel Syndrome - Symptom Severity Score
Time frame: 28 days
Irritable Bowel Syndrome - Symptom Severity Score
Time frame: 28 days
Adequate Relief
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Derived from this study: PubMed 38729393Singh P, Chey SW, Nee J, Eswaran S; Dietary Therapy in IBS Working Group; Lembo A, Chey WD. Is a Simplified, Less Restrictive Low FODMAP Diet Possible? Results From a Double-Blind, Pilot Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2025 Feb;23(2):362-364.e2. doi: 10.1016/j.cgh.2024.04.021. Epub 2024 May 9.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet A and Diet B in people with Irritable Bowel Syndrome, run by Beth Israel Deaconess Medical Center at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Johanna Iturrino Moreda, MD (6176672138, jiturrin@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Pain Intensity (time frame: 28 days). 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 NCT05831306, 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 28 Apr 2023.