Irritable Bowel Syndrome (IBS)IBS-CDEDNCT07707635
IBS-Oriented CDED Versus Low FODMAP Diet for Irritable Bowel Syndrome
A study testing Modified Crohn's Disease Exclusion Diet (CDED) and Low FODMAP Diet in people with Irritable Bowel Syndrome (IBS), run by Ariel University.
Trial summary
Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden. Recent evidence highlights the role of low-grade inflammation, impaired intestinal permeability and gut microbiota dysbiosis in the pathophysiology of non-constipated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- Modified Crohn's Disease Exclusion Diet (CDED) and Low FODMAP Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 7 Jul 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, men, and women (≥18 years) are diagnosed with IBS-D or IBS-M according to Rome IV criteria.
- Moderate-to-severe symptoms (IBS-SSS score ≥175).
- Stable use of any IBS-related medications for ≥6 weeks before study enrollment, except for antibiotics
Who cannot join
- Coexisting GI diseases [e.g., Crohn's disease, ulcerative colitis, SIBO, celiac disease [positive transglutaminase (TTG) serology].
- Disease that could explain or influence symptoms or GI function, including diabetes, thyroid disease [abnormal Thyroid-Stimulating Hormone (TSH)], and bariatric surgery.
- Recent intestinal resection.
- Pregnancy or breastfeeding.
- Known food allergies.
- Current active eating disorder
Show all 12Show fewer
- Participants already following a restrictive diet, including diets that overlap with the interventions in this study, will be excluded to prevent confounding effects on gut microbiota composition and gastrointestinal symptoms, and to ensure consistent baseline conditions. However, individuals who have discontinued such diets at least two to four weeks prior to enrollment may be eligible, allowing for a sufficient dietary washout period to minimize residual effects on the gut microbiota.
- Currently under obesity management medication treatment.
- Vegans
- Use of antibiotics within the 4 weeks prior to enrollment or during the study period.
- Abnormal hemoglobin levels (for women<11.5 gr/dl, for men<13 gr/dl)29
- Baseline CRP≥5
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Open-Label, Randomized Controlled Study to Assess the Efficacy of a Modified Crohn's Disease Exclusion Diet (CDED) Versus Low FODMAP Diet for Managing Non-Constipation Irritable Bowel Syndrome
Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden. Recent evidence highlights the role of low-grade inflammation, impaired intestinal permeability and gut microbiota dysbiosis in the pathophysiology of non-constipated IBS (IBS with predominate diarrhea; IBS-D and mixed type IBS; IBS-M). Most patients report food-related symptom exacerbation, making dietary intervention a cornerstone of treatment. While the low-FODMAP diet (LFD) is widely used to reduce fermentable carbohydrates and alleviate symptoms, it may negatively affect microbial diversity and lacks anti-inflammatory effects. In contrast, the Crohn's Disease Exclusion Diet (CDED), developed for Crohn's disease, has demonstrated the ability to reduce intestinal inflammation, improve barrier function, and promote a favorable microbiota profile. These mechanisms may be relevant and beneficial in IBS, but have yet to be studied in this population.
Objectives: To compare the efficacy of a modified CDED to the LFD for the treatment of non-constipated IBS symptoms, Hypothesis: A modified CDED will be at least as effective as the LFD in alleviating non-constipation IBS symptoms, stool consistency, quality of life, and psychological distress, while demonstrating superior effects on markers of low-grade inflammation, gut microbiota composition, and intestinal permeability.
Read more
Methods: This is a single-center, open-label, randomized study to be conducted at the Gastroenterology Department of Sheba Medical Center. 136 adults diagnosed with Rome IV-defined IBS-D or IBS-M and an IBS Symptom Severity Score (IBS-SSS) ≥175 will be randomized 1:1 to receive either a modified CDED or the LFD for 6 weeks. Accounting for a 10% dropout rate, the total sample size will be 150.
Following a 14-day screening period, eligible participants will undergo data collection at baseline, week 3 and week 6. Visit 1 (screening) will be conducted on-site; visits 2-4 will be remote. Participants will complete daily symptom diaries [Bristol Stool Form Scale (BSFS) and GI Visual Analogue Scale (VAS)], and weekly IBS-SSS. Validated questionnaires assessing psychological distress, somatization, extraintestinal symptoms, and quality of life will be administered at each time point.
Stool samples will be collected at baseline, week 3, and week 6. Fecal calprotectin (FC) and α1-Antitrypsin (A1AT) will be analyzed as markers of intestinal inflammation and permeability. Microbiota analysis will be conducted using 16S rRNA gene sequencing, with evaluation of microbial diversity, taxonomic shifts, and associations with clinical and biological outcomes.
Significance: This is the first study to evaluate the modified CDED as a dietary intervention for the treatment of IBS. It may offer a novel, inflammation-targeted alternative treatment for IBS.
Read the detailed description
Irritable bowel syndrome (IBS) is a disorder of gut-brain interaction characterized by chronic gastrointestinal symptoms in the absence of structural disease. Increasing evidence suggests that, particularly in non-constipated IBS (IBS-D and IBS-M), impaired intestinal barrier function, gut microbiota dysbiosis, mucosal immune activation, and low-grade inflammation contribute to symptom generation. These findings have shifted the focus of research toward dietary strategies that target underlying biological mechanisms rather than symptom reduction alone.
The low FODMAP diet is currently the most extensively studied dietary intervention for IBS and is recommended by international guidelines. However, despite its effectiveness in reducing gastrointestinal symptoms, concerns remain regarding its potential adverse effects on gut microbial diversity and the lack of evidence for improvement in intestinal inflammation or barrier integrity.
The Crohn's Disease Exclusion Diet (CDED) was originally developed for patients with Crohn's disease and has demonstrated favorable effects on intestinal inflammation, epithelial barrier function, and gut microbiota composition. Because several of these biological pathways are also implicated in IBS pathophysiology, an adapted version of the CDED may provide clinical benefits while simultaneously targeting disease mechanisms that are not addressed by current dietary approaches.
This study will evaluate, for the first time, an IBS-oriented adaptation of the CDED that excludes the enteral formula component used in Crohn's disease. In addition to evaluating clinical efficacy, the study will investigate potential biological mechanisms through serial assessment of fecal inflammatory markers, intestinal permeability markers, and gut microbiota composition. By integrating clinical, psychological, and biological outcomes, the study aims to determine whether this dietary intervention represents a mechanism-based alternative to the current dietary standard of care for patients with non-constipated IBS.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- Modified Crohn's Disease Exclusion Diet (CDED), Low FODMAP Diet
- Keywords
- Crohn's Disease Exclusion Diet (CDED), Low FODMAP Diet, Diet Therapy, Gut Microbiota, Intestinal Permeability, Fecal Calprotectin, Alpha-1 Antitrypsin, IBS-D, IBS-M
- Medical subject headings
- Irritable Bowel Syndrome, alpha 1-Antitrypsin Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Crohn's Disease Exclusion Diet (CDED)Other
Participants will follow a modified Crohn's Disease Exclusion Diet (CDED) adapted for patients with irritable bowel syndrome. The intervention excludes the enteral formula used in the original CDED protocol and is delivered for 6 weeks with individualized dietary counseling.
Low FODMAP DietOther
Participants will follow a standard low FODMAP diet for 6 weeks with individualized dietary counseling.
| Study group | Role | What they receive |
|---|---|---|
| Modified Crohn's Disease Exclusion Diet (CDED) | Experimental | Participants randomized to this arm will follow a modified Crohn's Disease Exclusion Diet (CDED) adapted for patients with irritable bowel syndrome. The intervention excludes the enteral formula used in the original CDED protocol and is delivered for 6 weeks with individualized dietary counseling. Receives: Other: Modified Crohn's Disease Exclusion Diet (CDED) |
| Low FODMAP Diet | Active comparator | Participants randomized to this arm will follow a standard low FODMAP diet for 6 weeks with individualized dietary counseling. Receives: Other: Low FODMAP Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants achieving a clinically meaningful response (≥50-point reduction in IBS Symptom Severity Score [IBS-SSS])
The primary efficacy outcome is the proportion of participants achieving a clinically meaningful response, defined as a reduction of at least 50 points from baseline in the IBS Symptom Severity Score (IBS-SSS) after 6 weeks of treatment. The IBS-SSS is a validated questionnaire ranging from 0 to 500, with higher scores indicating greater symptom severity.
Measured: Baseline and Week 6
Secondary outcomes (11)
Proportion of participants achieving a ≥100-point reduction in IBS Symptom Severity Score (IBS-SSS)
Proportion of participants achieving a reduction of at least 100 points from baseline in the IBS Symptom Severity Score (IBS-SSS) after 6 weeks of treatment.
Measured: Baseline and Week 6
Proportion of participants achieving a ≥50% reduction in IBS Symptom Severity Score (IBS-SSS)
Proportion of participants achieving a reduction of at least 50% from baseline in the IBS Symptom Severity Score (IBS-SSS) after 6 weeks of treatment.
Measured: Baseline and Week 6
Change from baseline in IBS Symptom Severity Score (IBS-SSS)
Absolute and percentage change from baseline in the IBS Symptom Severity Score (IBS-SSS). Scores range from 0 to 500, with higher scores indicating greater symptom severity.
Measured: Baseline, Week 3, and Week 6
Change from baseline in gastrointestinal symptom severity (Visual Analog Scale)
Absolute and percentage change from baseline in gastrointestinal symptom severity assessed using a Visual Analog Scale (VAS), with higher scores indicating greater symptom severity.
Measured: Baseline, Week 3, and Week 6
Change in quality of life
Change from baseline in IBS-specific quality of life measured using the IBS-Quality of Life questionnaire (IBS-QOL). Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: Baseline, Week 3, and Week 6
Change in psychological distress
Change from baseline in psychological distress assessed using the Hospital Anxiety and Depression Scale (HADS), a validated 14-item questionnaire consisting of two 7-item subscales assessing anxiety (HADS-A) and depression (HADS-D). Each subscale ranges from 0 to 21, with higher scores indicating greater symptom severity. Total HADS score ranges from 0 to 42, with higher scores indicating greater overall psychological distress.
Measured: Baseline, Week 3, and Week 6
Change in extraintestinal symptoms
Change from baseline in extraintestinal symptom burden assessed using a modified version of the Patient Health Questionnaire (PHQ-15), including 12 non-gastrointestinal items after exclusion of the three gastrointestinal symptom items (abdominal pain, constipation/diarrhea, and nausea/gas/indigestion). Each item is scored from 0 to 2, with higher scores indicating greater extraintestinal symptom burden.
Measured: Baseline, Week 3, and Week 6
Change in intestinal permeability measured by fecal α1-antitrypsin (A1AT)
Change from baseline in fecal α1-antitrypsin concentration, a biomarker of intestinal permeability.
Measured: Baseline, Week 3, and Week 6
Change in fecal calprotectin concentration
Change from baseline in fecal calprotectin concentration as a marker of intestinal inflammation.
Measured: Baseline, Week 3, and Week 6
Change in gut microbiota composition
Change from baseline in gut microbiota composition and diversity assessed by 16S rRNA gene sequencing.
Measured: Baseline, Week 3, and Week 6
Participants' experiences with the dietary intervention
Participants' perceptions, barriers, facilitators, and overall experiences with the assigned dietary intervention assessed through structured qualitative interviews.
Measured: Follow up: after completion of the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start7 Jul 2026 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies 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
- Model description
- Participants will be randomized in a 1:1 ratio to receive either a modified Crohn's Disease Exclusion Diet (CDED) or a Low FODMAP Diet for 6 weeks. Both intervention groups will be followed concurrently throughout the study.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center, Ministry of Innovation, Science and Technology of Israel
- Responsible party
- Sponsor
- Investigators
- Keren Hod, RD PhD, Study chair, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707635
- Sponsor's protocol ID
- 2495-25-SMC
- Other IDs
- 0009547, 202540302
- Acronym
- IBS-CDED
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 16 Jul 2026
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized Controlled Study to Assess the Efficacy of a Modified Crohn's Disease Exclusion Diet (CDED) Versus Low FODMAP Diet for Managing Non-Constipation Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07707635
- Acronym / sponsor ID
- IBS-CDED / 2495-25-SMC
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- Crohn's Disease Exclusion Diet (CDED), Low FODMAP Diet, Diet Therapy, Gut Microbiota, Intestinal Permeability, Fecal Calprotectin, Alpha-1 Antitrypsin, IBS-D
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Collaborators
- Sheba Medical Center, Ministry of Innovation, Science and Technology of Israel
- Study start
- 7 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Jul 2026 (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.
Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden. Recent evidence highlights the role of low-grade inflammation, impaired intestinal permeability and gut microbiota dysbiosis in the pathophysiology of non-constipated IBS (IBS with predominate diarrhea; IBS-D and mixed type IBS; IBS-M). Most patients report food-related symptom exacerbation, making dietary intervention a cornerstone of treatment. While the low-FODMAP diet (LFD) is widely used to reduce fermentable carbohydrates and alleviate symptoms, it may negatively affect microbial diversity and lacks anti-inflammatory effects. In contrast, the Crohn's Disease Exclusion Diet (CDED), developed for Crohn's disease, has demonstrated the ability to reduce intestinal inflammation, improve barrier function, and promote a favorable microbiota profile. These mechanisms may be relevant and beneficial in IBS, but have yet to be studied in this population.
Objectives: To compare the efficacy of a modified CDED to the LFD for the treatment of non-constipated IBS symptoms, Hypothesis: A modified CDED will be at least as effective as the LFD in alleviating non-constipation IBS symptoms, stool consistency, quality of life, and psychological distress, while demonstrating superior effects on markers of low-grade inflammation, gut microbiota composition, and intestinal permeability.
Methods: This is a single-center, open-label, randomized study to be conducted at the Gastroenterology Department of Sheba Medical Center. 136 adults diagnosed with Rome IV-defined IBS-D or IBS-M and an IBS Symptom Severity Score (IBS-SSS) ≥175 will be randomized 1:1 to receive either a modified CDED or the LFD for 6 weeks. Accounting for a 10% dropout rate, the total sample size will be 150.
Following a 14-day screening period, eligible participants will undergo data collection at baseline, week 3 and week 6. Visit 1 (screening) will be conducted on-site; visits 2-4 will be remote. Participants will complete daily symptom diaries [Bristol Stool Form Scale (BSFS) and GI Visual Analogue Scale (VAS)], and weekly IBS-SSS. Validated questionnaires assessing psychological distress, somatization, extraintestinal symptoms, and quality of life will be administered at each time point.
Stool samples will be collected at baseline, week 3, and week 6. Fecal calprotectin (FC) and α1-Antitrypsin (A1AT) will be analyzed as markers of intestinal inflammation and permeability. Microbiota analysis will be conducted using 16S rRNA gene sequencing, with evaluation of microbial diversity, taxonomic shifts, and associations with clinical and biological outcomes.
Significance: This is the first study to evaluate the modified CDED as a dietary intervention for the treatment of IBS. It may offer a novel, inflammation-targeted alternative treatment for IBS.
Detailed description
Irritable bowel syndrome (IBS) is a disorder of gut-brain interaction characterized by chronic gastrointestinal symptoms in the absence of structural disease. Increasing evidence suggests that, particularly in non-constipated IBS (IBS-D and IBS-M), impaired intestinal barrier function, gut microbiota dysbiosis, mucosal immune activation, and low-grade inflammation contribute to symptom generation. These findings have shifted the focus of research toward dietary strategies that target underlying biological mechanisms rather than symptom reduction alone.
The low FODMAP diet is currently the most extensively studied dietary intervention for IBS and is recommended by international guidelines. However, despite its effectiveness in reducing gastrointestinal symptoms, concerns remain regarding its potential adverse effects on gut microbial diversity and the lack of evidence for improvement in intestinal inflammation or barrier integrity.
The Crohn's Disease Exclusion Diet (CDED) was originally developed for patients with Crohn's disease and has demonstrated favorable effects on intestinal inflammation, epithelial barrier function, and gut microbiota composition. Because several of these biological pathways are also implicated in IBS pathophysiology, an adapted version of the CDED may provide clinical benefits while simultaneously targeting disease mechanisms that are not addressed by current dietary approaches.
This study will evaluate, for the first time, an IBS-oriented adaptation of the CDED that excludes the enteral formula component used in Crohn's disease. In addition to evaluating clinical efficacy, the study will investigate potential biological mechanisms through serial assessment of fecal inflammatory markers, intestinal permeability markers, and gut microbiota composition. By integrating clinical, psychological, and biological outcomes, the study aims to determine whether this dietary intervention represents a mechanism-based alternative to the current dietary standard of care for patients with non-constipated IBS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either a modified Crohn's Disease Exclusion Diet (CDED) or a Low FODMAP Diet for 6 weeks. Both intervention groups will be followed concurrently throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Modified Crohn's Disease Exclusion Diet (CDED) | Experimental | Other: Modified Crohn's Disease Exclusion Diet (CDED)Participants randomized to this arm will follow a modified Crohn's Disease Exclusion Diet (CDED) adapted for patients with irritable bowel syndrome. The intervention excludes the enteral formula used in the original CDED protocol and is delivered for 6 weeks with individualized dietary counseling. |
| Low FODMAP Diet | Active comparator | Other: Low FODMAP DietParticipants randomized to this arm will follow a standard low FODMAP diet for 6 weeks with individualized dietary counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults, men, and women (≥18 years) are diagnosed with IBS-D or IBS-M according to Rome IV criteria.
- Moderate-to-severe symptoms (IBS-SSS score ≥175).
- Stable use of any IBS-related medications for ≥6 weeks before study enrollment, except for antibiotics
Key exclusion criteria (12 listed)
- Coexisting GI diseases [e.g., Crohn's disease, ulcerative colitis, SIBO, celiac disease [positive transglutaminase (TTG) serology].
- Disease that could explain or influence symptoms or GI function, including diabetes, thyroid disease [abnormal Thyroid-Stimulating Hormone (TSH)], and bariatric surgery.
- Recent intestinal resection.
- Pregnancy or breastfeeding.
- Known food allergies.
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 |
|---|---|---|
| Modified Crohn's Disease Exclusion Diet (CDED)Participants will follow a modified Crohn's Disease Exclusion Diet (CDED) adapted for patients with irritable bowel syndrome. The intervention excludes the enteral formula used in the original CDED protocol and is delivered for 6 weeks with individualized dietary counseling. | Other | Modified Crohn's Disease Exclusion Diet (CDED) |
| Low FODMAP DietParticipants will follow a standard low FODMAP diet for 6 weeks with individualized dietary counseling. | Other | Low FODMAP Diet |
Primary outcome
Proportion of participants achieving a clinically meaningful response (≥50-point reduction in IBS Symptom Severity Score [IBS-SSS])
Time frame: Baseline and Week 6
The primary efficacy outcome is the proportion of participants achieving a clinically meaningful response, defined as a reduction of at least 50 points from baseline in the IBS Symptom Severity Score (IBS-SSS) after 6 weeks of treatment. The IBS-SSS is a validated questionnaire ranging from 0 to 500, with higher scores indicating greater symptom severity.
11 secondary outcomes
Proportion of participants achieving a ≥100-point reduction in IBS Symptom Severity Score (IBS-SSS)
Time frame: Baseline and Week 6
Proportion of participants achieving a ≥50% reduction in IBS Symptom Severity Score (IBS-SSS)
Time frame: Baseline and Week 6
Change from baseline in IBS Symptom Severity Score (IBS-SSS)
Time frame: Baseline, Week 3, and Week 6
Change from baseline in gastrointestinal symptom severity (Visual Analog Scale)
Time frame: Baseline, Week 3, and Week 6
Change in quality of life
Time frame: Baseline, Week 3, and Week 6
Change in psychological distress
Time frame: Baseline, Week 3, and Week 6
Change in extraintestinal symptoms
Time frame: Baseline, Week 3, and Week 6
Change in intestinal permeability measured by fecal α1-antitrypsin (A1AT)
Time frame: Baseline, Week 3, and Week 6
Change in fecal calprotectin concentration
Time frame: Baseline, Week 3, and Week 6
Change in gut microbiota composition
Time frame: Baseline, Week 3, and Week 6
Participants' experiences with the dietary intervention
Time frame: Follow up: after completion of the 6-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Study Recruitment WebsiteLink 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.
Keren Hod, RD PhD study chair
Ariel University
Questions about this trial
What is this clinical trial studying?
A study testing Modified Crohn's Disease Exclusion Diet (CDED) and Low FODMAP Diet in people with Irritable Bowel Syndrome (IBS), run by Ariel University.
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 3 inclusion and 12 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: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keren Hod, RD PhD (+972-53-2214380, kerenho@ariel.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants achieving a clinically meaningful response (≥50-point reduction in IBS Symptom Severity Score [IBS-SSS]) (time frame: Baseline and Week 6). 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 16 Jul 2026.