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| ID | Type | Description | Link |
|---|---|---|---|
| K23DK129327 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This research is studying whether changing an individual's diet may have an impact as a treatment or outcome for Irritable Bowel Syndrome (IBS). This research will show if diet might play a role in triggering changes that may cause IBS. This study is being done to learn if a low FODMAP (fermentable, oligosaccharides, disaccharides, monosaccharides, and polyols) diet causes changes in the colon lining which mediates improvement in IBS symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study patients with IBS-D | Experimental | Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a low FODMAP diet for 4 weeks | Other | low FODMAP diet for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lactulose Mannitol Excretion | Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet measured during 8-24h | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Epithelial Permeability - Tight Junction Gene Expression | Changes in tight junction (TJ) gene expression in colonic biopsies before and after low FODMAP diet Gene expression of Tight junction proteins were normalized to that of Glyceraldehyde 3-phosphate dehydrogenase (GAPDH). | 4 weeks |
| Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining |
| Measure | Description | Time Frame |
|---|---|---|
| Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) - 4-Week | Measure Description: IBS-SSS is a scale for assessing overall IBS symptom severity. It includes 5 questions concerning symptoms over the past 10 days: average severity of abdominal pain, # of days with abdominal pain, average severity of abdominal distension or bloating, satisfaction with bowel habits, and the overall interference in their quality of life from these symptoms. Questions are scored on a 0-100 scale and are summed to a total score between 0-500. Lower scores indicate lower symptom severity. Participants were separated into arms based on the change in their responses from baseline to 4 weeks. |
Inclusion Criteria:
In case of presence of any alarm features and/or elevated inflammatory markers (C-reactive protein or fecal calprotectin), patients will be eligible if they have been excluded for inflammatory bowel disease with colonoscopy in the last one year.
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Prashant Singh | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40749856 | Derived | Gao J, Lee AA, Abtahi S, Turner JR, Grover M, Schmidt A, Schmidt TM, Nee JW, Iturrino J, Lembo A, Chey WD, Wiley JW, Singh P. Low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols Diet Improves Colonic Barrier Function and Mast Cell Activation in Patients With Diarrhea-Predominant Irritable Bowel Syndrome: A Mechanistic Trial. Gastroenterology. 2026 Jan;170(1):132-147. doi: 10.1053/j.gastro.2025.07.016. Epub 2025 Jul 30. |
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All participants began the same 4-week Low FODMAP diet treatment. Once participants completed the 4-week intervention, they were categorized based on the changes in their IBSSS survey responses. Data was analyzed for each group separately. Participants who did not submit their IBSSS surveys after 4-weeks of treatment could not be placed in either group, submitted no data, and are not considered to have "completed" the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Responders | Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points. |
| FG001 | Non-Responders | Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points. |
| FG002 | Intervention Recipients Who Did Not Complete the Trial | These participants began the 4 week Low FODMAP diet treatment, but did not complete the treatment or report data to study team. They were, therefore, not categorized into "responders" or "non-responders". |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Responders | Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lactulose Mannitol Excretion | Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet measured during 8-24h | No data was collected from "Intervention Recipients Who Did Not Complete The Trial" arm | Posted | Median | Full Range | micrograms per ml | 4 weeks |
|
4 weeks
Participants were encouraged to contact the study team if they experienced adverse events and were provided with contact information in the informed consent document. The study team did not specifically ask participants about adverse events or search medical records for potential AEs. Therefore, while all data collected is reported below, participants could have chosen not to report adverse events they experienced.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Responders | Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-Vaccination Stomach Pain and Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prashant Singh, MBBS | University of Michigan | 734-647-1191 | singhpr@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 8, 2022 | Jun 3, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 24, 2020 | May 24, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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Patients with diarrhea predominant IBS (IBS-D) will undergo 4 weeks of low FODMAP diet. Urine, blood, stool, and colon biopsies will be collected before and after the diet to assess changes in gut physiology.
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Changes in Quantitative tight junction immunostaining of tight junctions in colonic biopsies before and after low FODMAP diet Data is reported as ratio of TJ proteins to NA-K ATPase. |
| 4 weeks |
| Changes in Stool Microbiome - Alpha Diversity | Changes in relative abundance of bacteria before and after low FODMAP diet. Alpha diversity was measured as number of Amplicon Sequence Variant (ASV) measured in the specimen. | 4 weeks |
| Changes in Stool Microbiome - Beta Diversity | Changes in relative abundance of bacteria before and after low FODMAP diet. For the beta diversity, an analysis of similarities (ANOSIM)test based on Bray-Curtis distances is the best measure if the communities were different. The ANOSIM R statistic gives the scale of difference. ANOSIM R ranges from -1 to 1, where 1 means there is most interparticipant similarity within the group compared with between the different groups, and where -1 means there is least interparticipant similarity within the group compared with between the different groups. A value close to 0 indicates no significant difference between groups, meaning the dissimilarity is similar both within and between groups | 4 weeks |
| Immunohistochemistry for Mast Cells | Number of mast cells in sample after immunohistochemistry were counted. | 4 weeks |
| Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | PROMIS scales of Belly pain (5a) and diarrhea (6a) will be administered to assess the severity of belly pain and diarrhea in our patients. PROMIS Belly pain questionnaire and PROMIS diarrhea questionnaire have five and six questions, respectively, which assess symptom severity on a 5 point Likert scale. 50 indicates the general population mean with a standard deviation of 10. Higher T-scores on these questionnaires refer to more severe gastrointestinal symptoms. PROMIS belly pain asks how often did you have belly pain, severity of belly pain, interference with activities, bothersomeness and discomfort. PROMIS diarrhea asks how many days did you have loose stools, interference with activities, bothersomeness, and how often you experience urgency. | 4 weeks |
| 4 weeks |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Non-Responders |
Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points. |
| BG002 | Intervention Recipients Who Did Not Complete the Trial | These participants began the 4 week Low FODMAP diet treatment, but did not complete the treatment or report data to study team. They were, therefore, not categorized into "responders" or "non-responders". |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) | IBS-SSS is a scale for assessing overall IBS symptom severity. It includes 5 questions concerning symptoms over the past 10 days: average severity of abdominal pain, # of days with abdominal pain, average severity of abdominal distension or bloating, satisfaction with bowel habits, and the overall interference in their quality of life from these symptoms. Questions are scored on a 0-100 scale and are summed to a total score between 0-500. Lower scores indicate lower symptom severity. Participants were separated into arms based on the change in their responses from baseline to 4 weeks. | Because 6 participants who did not finish the trial did not provide week 4 IBS-SSS, they are not included in the analysis | Mean | Standard Deviation | score on a scale |
|
|
|
| Secondary | Changes in Epithelial Permeability - Tight Junction Gene Expression | Changes in tight junction (TJ) gene expression in colonic biopsies before and after low FODMAP diet Gene expression of Tight junction proteins were normalized to that of Glyceraldehyde 3-phosphate dehydrogenase (GAPDH). | No data was analyzed for the "Intervention Recipients Who Did Not Complete The Trial" arm because those participants did not submit second sample. | Posted | Median | Full Range | ratio of TJ proteins to GAPDH | 4 weeks |
|
|
|
| Secondary | Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining | Changes in Quantitative tight junction immunostaining of tight junctions in colonic biopsies before and after low FODMAP diet Data is reported as ratio of TJ proteins to NA-K ATPase. | No data was analyzed for the "Intervention Recipients Who Did Not Complete The Trial" arm because those participants did not submit second sample. | Posted | Median | Full Range | ratio of TJ proteins to NA-K ATPase | 4 weeks |
|
|
|
| Secondary | Changes in Stool Microbiome - Alpha Diversity | Changes in relative abundance of bacteria before and after low FODMAP diet. Alpha diversity was measured as number of Amplicon Sequence Variant (ASV) measured in the specimen. | No data was analyzed for the "Intervention Recipients Who Did Not Complete the Trial" arm because participants did not submit necessary samples for analysis. | Posted | Mean | Standard Deviation | ASVs Observed | 4 weeks |
|
|
|
| Secondary | Changes in Stool Microbiome - Beta Diversity | Changes in relative abundance of bacteria before and after low FODMAP diet. For the beta diversity, an analysis of similarities (ANOSIM)test based on Bray-Curtis distances is the best measure if the communities were different. The ANOSIM R statistic gives the scale of difference. ANOSIM R ranges from -1 to 1, where 1 means there is most interparticipant similarity within the group compared with between the different groups, and where -1 means there is least interparticipant similarity within the group compared with between the different groups. A value close to 0 indicates no significant difference between groups, meaning the dissimilarity is similar both within and between groups | No data was analyzed for the "Intervention Recipients Who Did Not Complete the Trial" arm because participants did not submit necessary samples for analysis. Some participants in both analyzed arms did not provide samples of sufficient quality for analysis. | Posted | Number | units on a scale | 4 weeks |
|
|
|
| Secondary | Immunohistochemistry for Mast Cells | Number of mast cells in sample after immunohistochemistry were counted. | No data was analyzed for "Intervention Recipients Who Did Not Complete the Trial", as they did not submit necessary samples. | Posted | Median | Full Range | mast cell count per high power field | 4 weeks |
|
|
|
| Secondary | Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS) | PROMIS scales of Belly pain (5a) and diarrhea (6a) will be administered to assess the severity of belly pain and diarrhea in our patients. PROMIS Belly pain questionnaire and PROMIS diarrhea questionnaire have five and six questions, respectively, which assess symptom severity on a 5 point Likert scale. 50 indicates the general population mean with a standard deviation of 10. Higher T-scores on these questionnaires refer to more severe gastrointestinal symptoms. PROMIS belly pain asks how often did you have belly pain, severity of belly pain, interference with activities, bothersomeness and discomfort. PROMIS diarrhea asks how many days did you have loose stools, interference with activities, bothersomeness, and how often you experience urgency. | Participants in the "Intervention Recipients who did not Complete the Trial" arm did not submit surveys at the 4-week point. | Posted | Mean | Standard Deviation | T-score | 4 weeks |
|
|
|
| Other Pre-specified | Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) - 4-Week | Measure Description: IBS-SSS is a scale for assessing overall IBS symptom severity. It includes 5 questions concerning symptoms over the past 10 days: average severity of abdominal pain, # of days with abdominal pain, average severity of abdominal distension or bloating, satisfaction with bowel habits, and the overall interference in their quality of life from these symptoms. Questions are scored on a 0-100 scale and are summed to a total score between 0-500. Lower scores indicate lower symptom severity. Participants were separated into arms based on the change in their responses from baseline to 4 weeks. | Because 6 participants who did not finish the trial did not provide week 4 IBS-SSS, they were sorted into the third arm and not included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks |
|
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| 0 |
| 34 |
| 0 |
| 34 |
| 2 |
| 34 |
| EG001 | Non-Responders | Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Intervention Recipients Who Did Not Complete the Trial | These participants began the 4 week Low FODMAP diet treatment, but did not complete the treatment or report data to study team. They were, therefore, not categorized into "responders" or "non-responders". | 0 | 6 | 0 | 6 | 0 | 6 |
| Ankle fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | Non-systematic Assessment |
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| D004066 | Digestive System Diseases |
| 4-week - ZO-1 |
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| Baseline - JAM-A |
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| 4-week - JAM-A |
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| Baseline - Occludin |
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| 4-week - Occludin |
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| Baseline - Claudin-1 |
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| 4-week - Claudin-1 |
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| 4-week - ZO-1 |
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| Baseline - JAM-A |
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| 4-week - JAM-A |
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| Baseline - Occludin |
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| 4-week - Occludin |
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| Baseline - Claudin-1 |
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| 4-week - Claudin-1 |
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| 4-week - Alpha Diversity |
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| 4-Week - Mast Cell Count |
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| 4-week - Belly Pain |
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| Baseline - Diarrhea |
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| 4-week - Diarrhea |
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