Irritable Bowel SyndromeNCT04526808
Effects of Low FODMAP Diet on Leaky Gut
A study testing FODMAP diet in people with Irritable Bowel Syndrome, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial summary
The pathophysiology of Irritable bowel syndrome (IBS) is multifactorial involving complex interplay of altered intestinal permeability, mucosal immune activation, visceral hypersensitivity and gut dysbiosis. 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?
- FODMAP diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 May 2019to 1 Jun 2021
- 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
- aged 18-65 years at the time of screening
- normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein, complete blood count since the onset of symptoms
- normal stool studies including C diff testing, culture, ova and parasites since the onset of symptoms
- IBS-SSS score of ≥175 at the end of 7-day screening period
Who cannot join
- individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
- individuals with any known food allergy or insulin-dependent diabetes
- known history of celiac disease, inflammatory bowel disease or microscopic colitis
- prior small bowel or colonic surgery or cholecystectomy
- pregnant patients
- antibiotics in the past 3 months
- those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Effects of Low FODMAP Diet on Leaky Gut and Mucosal Immune Cell Abundance in Diarrhea-predominant Irritable Bowel Syndrome
The pathophysiology of Irritable bowel syndrome (IBS) is multifactorial involving complex interplay of altered intestinal permeability, mucosal immune activation, visceral hypersensitivity and gut dysbiosis. Although the exact triggers for these pathological changes in IBS are not clear but diet might play an important role. In fact, several studies have reported improvement in gastrointestinal symptoms on a diet low in FODMAPs (LFD) in patients with IBS, specifically in diarrhea predominant IBS (IBS-D). However, the mechanism of action of LFD is not well understood.
Read the detailed description
we aim to evaluate the following in patients with IBS-D. The effect of LFD on colonic permeability. 2.The effect of LFD on abundance of colonic mucosal immune cells specifically T-cell and mast cell abundance 3.The effect of LFD on colonic mucosal microbiome
- Conditions
- Irritable Bowel Syndrome
- Being tested
- FODMAP diet
- 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.
FODMAP dietOther
low FODMAP diet
| Study group | Role | What they receive |
|---|---|---|
| FODMAP diet | Experimental | Not described Receives: Other: FODMAP diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
colonic permeability
Lactulose:Mannitol ratio pre and post treatment
Measured: 4 weeks
Secondary outcomes (2)
colonic immune cells
expression of tight junction proteins pre and post treatment using RT-PCR
Measured: 4 weeks
colonic microbiome
relative stool microbial abundance pre and post treatment measured using 16s RNA
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start20 May 2019
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
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.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Judy Nee, Beth Israel Deaconess Medical Center
- Investigators
- Judy Nee, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526808
- Sponsor's protocol ID
- 2019P000149
- Status last verified
- May 2025
- First submitted
- 5 Aug 2020
- Last updated
- 23 May 2025
- 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 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low FODMAP Diet on Leaky Gut and Mucosal Immune Cell Abundance in Diarrhea-predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04526808
- Acronym / sponsor ID
- 2019P000149
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- 20 May 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 26 Aug 2020 (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.
The pathophysiology of Irritable bowel syndrome (IBS) is multifactorial involving complex interplay of altered intestinal permeability, mucosal immune activation, visceral hypersensitivity and gut dysbiosis. Although the exact triggers for these pathological changes in IBS are not clear but diet might play an important role. In fact, several studies have reported improvement in gastrointestinal symptoms on a diet low in FODMAPs (LFD) in patients with IBS, specifically in diarrhea predominant IBS (IBS-D). However, the mechanism of action of LFD is not well understood.
Detailed description
we aim to evaluate the following in patients with IBS-D. The effect of LFD on colonic permeability. 2.The effect of LFD on abundance of colonic mucosal immune cells specifically T-cell and mast cell abundance 3.The effect of LFD on colonic mucosal microbiome
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FODMAP diet | Experimental | Other: FODMAP diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18-65 years at the time of screening
- normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein, complete blood count since the onset of symptoms
- normal stool studies including C diff testing, culture, ova and parasites since the onset of symptoms
- IBS-SSS score of ≥175 at the end of 7-day screening period
Key exclusion criteria (7 listed)
- individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
- individuals with any known food allergy or insulin-dependent diabetes
- known history of celiac disease, inflammatory bowel disease or microscopic colitis
- prior small bowel or colonic surgery or cholecystectomy
- pregnant patients
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 |
|---|---|---|
| FODMAP dietlow FODMAP diet | Other | FODMAP diet |
Primary outcome
colonic permeability
Time frame: 4 weeks
Lactulose:Mannitol ratio pre and post treatment
2 secondary outcomes
colonic immune cells
Time frame: 4 weeks
colonic microbiome
Time frame: 4 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 23 May 2025.
- 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.
Judy Nee, MD principal investigator
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FODMAP diet 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 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: finished, as of the sponsor's last update on 23 May 2025. 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?
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?
colonic permeability (time frame: 4 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 23 May 2025.