Trial Outcomes & Findings for Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome (NCT NCT04542018)
NCT ID: NCT04542018
Last Updated: 2025-07-30
Results Overview
Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet measured during 8-24h
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
4 weeks
Results posted on
2025-07-30
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
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".
|
|---|---|---|---|
|
Overall Study
STARTED
|
34
|
8
|
6
|
|
Overall Study
COMPLETED
|
34
|
8
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
6
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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".
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
4
|
|
Overall Study
Protocol Violation
|
0
|
0
|
2
|
Baseline Characteristics
Because 6 participants who did not finish the trial did not provide week 4 IBS-SSS, they are not included in the analysis
Baseline characteristics by cohort
| Measure |
Responders
n=34 Participants
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.
|
Non-Responders
n=8 Participants
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.
|
Intervention Recipients Who Did Not Complete the Trial
n=6 Participants
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".
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.3 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
44.6 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
32.2 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
34 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS)
|
334.2 score on a scale
STANDARD_DEVIATION 81.36 • n=5 Participants • Because 6 participants who did not finish the trial did not provide week 4 IBS-SSS, they are not included in the analysis
|
254.5 score on a scale
STANDARD_DEVIATION 65.52 • n=7 Participants • Because 6 participants who did not finish the trial did not provide week 4 IBS-SSS, they are not included in the analysis
|
303.6 score on a scale
STANDARD_DEVIATION 113.1 • n=5 Participants • Because 6 participants who did not finish the trial did not provide week 4 IBS-SSS, they are not included in the analysis
|
317.4 score on a scale
STANDARD_DEVIATION 86.2 • n=4 Participants • Because 6 participants who did not finish the trial did not provide week 4 IBS-SSS, they are not included in the analysis
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: No data was collected from "Intervention Recipients Who Did Not Complete The Trial" arm
Changes in cumulative excretion of lactulose and mannitol in timed urine collection before and after low FODMAP diet measured during 8-24h
Outcome measures
| Measure |
Responders
n=34 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
Non-Responders
n=8 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
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".
|
|---|---|---|---|
|
Lactulose Mannitol Excretion
Baseline - Lactulose Excretion
|
512.5 micrograms per ml
Interval 99.0 to 3456.0
|
394.5 micrograms per ml
Interval 204.0 to 1982.0
|
—
|
|
Lactulose Mannitol Excretion
4-Week - Lactulose Excretion
|
456.8 micrograms per ml
Interval 60.0 to 1568.0
|
411 micrograms per ml
Interval 221.4 to 992.5
|
—
|
|
Lactulose Mannitol Excretion
Baseline - Mannitol Excretion
|
41395 micrograms per ml
Interval 9600.0 to 430100.0
|
86820 micrograms per ml
Interval 79040.0 to 207900.0
|
—
|
|
Lactulose Mannitol Excretion
4-Week - Mannitol Excretion
|
37030 micrograms per ml
Interval 2704.0 to 83356.0
|
54825 micrograms per ml
Interval 11314.0 to 500480.0
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: No data was analyzed for the "Intervention Recipients Who Did Not Complete The Trial" arm because those participants did not submit second sample.
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).
Outcome measures
| Measure |
Responders
n=34 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
Non-Responders
n=8 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
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".
|
|---|---|---|---|
|
Changes in Epithelial Permeability - Tight Junction Gene Expression
Baseline - ZO-1
|
.9 ratio of TJ proteins to GAPDH
Interval 0.1 to 3.5
|
.7 ratio of TJ proteins to GAPDH
Interval 0.1 to 1.0
|
—
|
|
Changes in Epithelial Permeability - Tight Junction Gene Expression
4-week - ZO-1
|
1.4 ratio of TJ proteins to GAPDH
Interval 0.3 to 4.8
|
1.1 ratio of TJ proteins to GAPDH
Interval 0.2 to 3.2
|
—
|
|
Changes in Epithelial Permeability - Tight Junction Gene Expression
Baseline - JAM-A
|
0.9 ratio of TJ proteins to GAPDH
Interval 0.03 to 2.6
|
0.5 ratio of TJ proteins to GAPDH
Interval 0.1 to 1.3
|
—
|
|
Changes in Epithelial Permeability - Tight Junction Gene Expression
4-week - JAM-A
|
2 ratio of TJ proteins to GAPDH
Interval 0.2 to 7.2
|
1.3 ratio of TJ proteins to GAPDH
Interval 0.1 to 3.3
|
—
|
|
Changes in Epithelial Permeability - Tight Junction Gene Expression
Baseline - Occludin
|
0.9 ratio of TJ proteins to GAPDH
Interval 0.1 to 3.0
|
0.6 ratio of TJ proteins to GAPDH
Interval 0.1 to 1.1
|
—
|
|
Changes in Epithelial Permeability - Tight Junction Gene Expression
4-week - Occludin
|
1.3 ratio of TJ proteins to GAPDH
Interval 0.1 to 4.8
|
0.8 ratio of TJ proteins to GAPDH
Interval 0.1 to 2.1
|
—
|
|
Changes in Epithelial Permeability - Tight Junction Gene Expression
Baseline - Claudin-1
|
0.6 ratio of TJ proteins to GAPDH
Interval 0.01 to 3.8
|
0.5 ratio of TJ proteins to GAPDH
Interval 0.1 to 3.7
|
—
|
|
Changes in Epithelial Permeability - Tight Junction Gene Expression
4-week - Claudin-1
|
1.1 ratio of TJ proteins to GAPDH
Interval 0.04 to 3.7
|
0.9 ratio of TJ proteins to GAPDH
Interval 0.1 to 2.5
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: No data was analyzed for the "Intervention Recipients Who Did Not Complete The Trial" arm because those participants did not submit second sample.
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.
Outcome measures
| Measure |
Responders
n=34 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
Non-Responders
n=8 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
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".
|
|---|---|---|---|
|
Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining
Baseline - ZO-1
|
0.06579 ratio of TJ proteins to NA-K ATPase
Interval 0.008542 to 0.388
|
0.03703 ratio of TJ proteins to NA-K ATPase
Interval 0.01876 to 0.07138
|
—
|
|
Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining
4-week - ZO-1
|
0.07330 ratio of TJ proteins to NA-K ATPase
Interval 0.01938 to 0.3061
|
0.05063 ratio of TJ proteins to NA-K ATPase
Interval 0.0452 to 0.07585
|
—
|
|
Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining
Baseline - JAM-A
|
0.07493 ratio of TJ proteins to NA-K ATPase
Interval 0.01628 to 0.2034
|
0.08437 ratio of TJ proteins to NA-K ATPase
Interval 0.0269 to 0.09409
|
—
|
|
Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining
4-week - JAM-A
|
0.09149 ratio of TJ proteins to NA-K ATPase
Interval 0.0222 to 0.3186
|
0.07267 ratio of TJ proteins to NA-K ATPase
Interval 0.055 to 0.09367
|
—
|
|
Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining
Baseline - Occludin
|
2.623 ratio of TJ proteins to NA-K ATPase
Interval 0.6874 to 16.95
|
3.834 ratio of TJ proteins to NA-K ATPase
Interval 2.624 to 9.378
|
—
|
|
Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining
4-week - Occludin
|
5.529 ratio of TJ proteins to NA-K ATPase
Interval 0.7352 to 13.05
|
5.533 ratio of TJ proteins to NA-K ATPase
Interval 2.724 to 16.5
|
—
|
|
Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining
Baseline - Claudin-1
|
6.542 ratio of TJ proteins to NA-K ATPase
Interval 0.5603 to 20.69
|
10.40 ratio of TJ proteins to NA-K ATPase
Interval 7.514 to 12.13
|
—
|
|
Changes in Epithelial Permeability - Quantitative Tight Junction Immunostaining
4-week - Claudin-1
|
11.22 ratio of TJ proteins to NA-K ATPase
Interval 1.696 to 17.38
|
9.218 ratio of TJ proteins to NA-K ATPase
Interval 1.108 to 20.86
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: No data was analyzed for the "Intervention Recipients Who Did Not Complete the Trial" arm because participants did not submit necessary samples for analysis.
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.
Outcome measures
| Measure |
Responders
n=34 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
Non-Responders
n=8 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
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".
|
|---|---|---|---|
|
Changes in Stool Microbiome - Alpha Diversity
Baseline - Alpha Diversity
|
649.087 ASVs Observed
Standard Deviation 160.1794
|
532.75 ASVs Observed
Standard Deviation 153.69
|
—
|
|
Changes in Stool Microbiome - Alpha Diversity
4-week - Alpha Diversity
|
599.7391 ASVs Observed
Standard Deviation 159.1749
|
608.5 ASVs Observed
Standard Deviation 182.12
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: 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.
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
Outcome measures
| Measure |
Responders
n=23 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
Non-Responders
n=4 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
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".
|
|---|---|---|---|
|
Changes in Stool Microbiome - Beta Diversity
|
-0.03722 units on a scale
|
-0.2708 units on a scale
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: No data was analyzed for "Intervention Recipients Who Did Not Complete the Trial", as they did not submit necessary samples.
Number of mast cells in sample after immunohistochemistry were counted.
Outcome measures
| Measure |
Responders
n=34 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
Non-Responders
n=8 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
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".
|
|---|---|---|---|
|
Immunohistochemistry for Mast Cells
4-Week - Mast Cell Count
|
14.5 mast cell count per high power field
Interval 5.4 to 25.8
|
11.5 mast cell count per high power field
Interval 9.5 to 24.2
|
—
|
|
Immunohistochemistry for Mast Cells
Baseline - Mast Cell Count
|
23 mast cell count per high power field
Interval 5.2 to 42.5
|
26.5 mast cell count per high power field
Interval 18.7 to 27.2
|
—
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Participants in the "Intervention Recipients who did not Complete the Trial" arm did not submit surveys at the 4-week point.
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.
Outcome measures
| Measure |
Responders
n=34 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
Non-Responders
n=8 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
Intervention Recipients Who Did Not Complete the Trial
n=6 Participants
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".
|
|---|---|---|---|
|
Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS)
Baseline - Belly Pain
|
63.6 T-score
Standard Deviation 6.2
|
64.1 T-score
Standard Deviation 5.1
|
63.7 T-score
Standard Deviation 6.4
|
|
Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS)
4-week - Belly Pain
|
47.1 T-score
Standard Deviation 9.4
|
60.8 T-score
Standard Deviation 3.1
|
—
|
|
Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS)
Baseline - Diarrhea
|
61.2 T-score
Standard Deviation 10.8
|
49.1 T-score
Standard Deviation 8.3
|
61.3 T-score
Standard Deviation 5
|
|
Gastrointestinal Patient Reported Outcomes Measurement Information System (PROMIS)
4-week - Diarrhea
|
55.8 T-score
Standard Deviation 8.3
|
55.6 T-score
Standard Deviation 8.4
|
0 T-score
Standard Deviation 0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Responders
n=34 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
Non-Responders
n=8 Participants
Patients with diarrhea-predominant IBS who will undergo a 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.
|
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".
|
|---|---|---|---|
|
Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) - 4-Week
|
87.7 score on a scale
Standard Deviation 84.8
|
235.4 score on a scale
Standard Deviation 72.12
|
—
|
Adverse Events
Responders
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Non-Responders
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Recipients Who Did Not Complete the Trial
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Responders
n=34 participants at risk
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.
|
Non-Responders
n=8 participants at risk
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.
|
Intervention Recipients Who Did Not Complete the Trial
n=6 participants at risk
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".
|
|---|---|---|---|
|
Gastrointestinal disorders
Post-Vaccination Stomach Pain and Diarrhea
|
2.9%
1/34 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/6 • 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.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
2.9%
1/34 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/6 • 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.
|
|
Infections and infestations
COVID-19
|
2.9%
1/34 • 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.
|
0.00%
0/8 • 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.
|
0.00%
0/6 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place