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).
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.
Baseline - ZO-1
Group
Value
95% CI
Responders
0.06579
0.008542 – 0.3880
Non-Responders
0.03703
0.01876 – 0.07138
4-week - ZO-1
Group
Value
95% CI
Responders
0.07330
0.01938 – 0.3061
Non-Responders
0.05063
0.04520 – 0.07585
Baseline - JAM-A
Group
Value
95% CI
Responders
0.07493
0.01628 – 0.2034
Non-Responders
0.08437
0.02690 – 0.09409
4-week - JAM-A
Group
Value
95% CI
Responders
0.09149
0.02220 – 0.3186
Non-Responders
0.07267
0.05500 – 0.09367
Baseline - Occludin
Group
Value
95% CI
Responders
2.623
0.6874 – 16.95
Non-Responders
3.834
2.624 – 9.378
4-week - Occludin
Group
Value
95% CI
Responders
5.529
0.7352 – 13.05
Non-Responders
5.533
2.724 – 16.5
Baseline - Claudin-1
Group
Value
95% CI
Responders
6.542
0.5603 – 20.69
Non-Responders
10.40
7.514 – 12.13
4-week - Claudin-1
Group
Value
95% CI
Responders
11.22
1.696 – 17.38
Non-Responders
9.218
1.108 – 20.86
Changes in Stool Microbiome - Alpha DiversitySecondary· 4 weeks
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.
Baseline - Alpha Diversity
Group
Value
95% CI
Responders
649.087
± 160.1794
Non-Responders
532.75
± 153.69
4-week - Alpha Diversity
Group
Value
95% CI
Responders
599.7391
± 159.1749
Non-Responders
608.5
± 182.12
Changes in Stool Microbiome - Beta DiversitySecondary· 4 weeks
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 diffe
Group
Value
95% CI
Responders
-0.03722
Non-Responders
-0.2708
Immunohistochemistry for Mast CellsSecondary· 4 weeks
Number of mast cells in sample after immunohistochemistry were counted.
Baseline - Mast Cell Count
Group
Value
95% CI
Responders
23
5.2 – 42.5
Non-Responders
26.5
18.7 – 27.2
4-Week - Mast Cell Count
Group
Value
95% CI
Responders
14.5
5.4 – 25.8
Non-Responders
11.5
9.5 – 24.2
Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS)Secondary· 4 weeks
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 d
Baseline - Belly Pain
Group
Value
95% CI
Responders
63.6
± 6.2
Non-Responders
64.1
± 5.1
Intervention Recipients Who Did Not Complete the Trial
63.7
± 6.4
4-week - Belly Pain
Group
Value
95% CI
Responders
47.1
± 9.4
Non-Responders
60.8
± 3.1
Baseline - Diarrhea
Group
Value
95% CI
Responders
61.2
± 10.8
Non-Responders
49.1
± 8.3
Intervention Recipients Who Did Not Complete the Trial
61.3
± 5
4-week - Diarrhea
Group
Value
95% CI
Responders
55.8
± 8.3
Non-Responders
55.6
± 8.4
Intervention Recipients Who Did Not Complete the Trial
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 baselin
Group
Value
95% CI
Responders
87.7
± 84.8
Non-Responders
235.4
± 72.12
Adverse events — posted to ClinicalTrials.gov
Time frame: 4 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Responders
Serious: 0/34 (0%)
Deaths: 0/34
Non-Responders
Serious: 0/8 (0%)
Deaths: 0/8
Intervention Recipients Who Did Not Complete the Trial
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Michigan
Last refreshed: 30 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04542018.