Trial Outcomes & Findings for Evaluating the Efficacy of the Mediterranean Diet to the Low- Fermentable, Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAP) Diet in Treating Irritable Bowel Syndrome(IBS) (NCT NCT05807919)
NCT ID: NCT05807919
Last Updated: 2025-03-28
Results Overview
Results reflect the participants who were weekly responders for at least 2 of the 4 weeks based on their abdominal pain intensity score. The abdominal pain score was a single-question, 11-point numeric rating scale in which 0 represented no abdominal pain and 11 represented the worst possible abdominal pain. Once per day, subjects reported their worst daily (in the past 24 hours) abdominal pain. A weekly responder was defined as a participant whose score decreased in the weekly average of worst abdominal pain in the past 24 hours by at least 30% compared with baseline.
COMPLETED
NA
26 participants
4 weeks
2025-03-28
Participant Flow
Participant milestones
| Measure |
Diet Low in All FODMAP Groups
Diet low in all FODMAP groups: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
Diet - Mediterranean
Diet - Mediterranean: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
15
|
|
Overall Study
Actual Treatment Begun (Day 1)
|
11
|
14
|
|
Overall Study
Elected to Continue Treatment After Day 1
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Diet Low in All FODMAP Groups
Diet low in all FODMAP groups: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
Diet - Mediterranean
Diet - Mediterranean: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
|---|---|---|
|
Overall Study
Received antibiotics - excluded
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Adverse Event
|
1
|
1
|
Baseline Characteristics
Evaluating the Efficacy of the Mediterranean Diet to the Low- Fermentable, Oligosaccharides, Disaccharides, Monosaccharides, and Polyols (FODMAP) Diet in Treating Irritable Bowel Syndrome(IBS)
Baseline characteristics by cohort
| Measure |
Diet Low in All FODMAP Groups
n=11 Participants
Diet low in all FODMAP groups: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
Diet - Mediterranean
n=15 Participants
Diet - Mediterranean: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.09 years
STANDARD_DEVIATION 19.5 • n=5 Participants
|
38.13 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
41.1 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Results are based on a modified intent to treat (mITT) analysis. Participants categorized in the Participant Flow as "Withdrawal by Subject" were not included in the mITT analysis.
Results reflect the participants who were weekly responders for at least 2 of the 4 weeks based on their abdominal pain intensity score. The abdominal pain score was a single-question, 11-point numeric rating scale in which 0 represented no abdominal pain and 11 represented the worst possible abdominal pain. Once per day, subjects reported their worst daily (in the past 24 hours) abdominal pain. A weekly responder was defined as a participant whose score decreased in the weekly average of worst abdominal pain in the past 24 hours by at least 30% compared with baseline.
Outcome measures
| Measure |
Diet Low in All FODMAP Groups
n=11 Participants
Diet low in all FODMAP groups: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
Diet - Mediterranean
n=11 Participants
Diet - Mediterranean: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
|---|---|---|
|
Proportion of Participants Who Are Responders Based on the Abdominal Pain Intensity Score for at Least 2 of 4 Weeks
|
9 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Results are based on a mITT analysis. Participants categorized in the Participant Flow as "Withdrawal by Subject" were not included in the mITT analysis.
Results reflect the participants who were weekly responders based on the adequate relief symptom assessment for at least 2 of the 4 weeks. Participants provided a binary (yes or no) response to rate the adequacy of relief of global irritable bowel syndrome (IBS) symptoms at the start of the study and weekly thereafter. A weekly responder was defined as a participant who achieved adequate relief in symptoms in at least 2 out of 4 weeks of the treatment period.
Outcome measures
| Measure |
Diet Low in All FODMAP Groups
n=11 Participants
Diet low in all FODMAP groups: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
Diet - Mediterranean
n=11 Participants
Diet - Mediterranean: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
|---|---|---|
|
Proportion of Participants Who Are Weekly Responders to Adequate Relief Symptom Assessment for at Least 2 of 4 Weeks
|
6 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Results are based on a mITT analysis. Participants categorized in the Participant Flow as "Withdrawal by Subject" were not included in the mITT analysis.
Results reflect participants who were weekly responders for at least 2 of the 4 weeks based on their scores on a modified version of the IBS-SSS. This version of the IBS-SSS was comprised of 5 questions participants answered based on their stomach and bowels. The total score for this modified version of the IBS-SSS was 0-500, with 0 indicating no IBS symptoms and 500 indicating the highest amount of IBS symptoms. A weekly responder was defined as a participant whose score decreased in the weekly IBS-SSS by at least 50 points compared with baseline.
Outcome measures
| Measure |
Diet Low in All FODMAP Groups
n=11 Participants
Diet low in all FODMAP groups: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
Diet - Mediterranean
n=11 Participants
Diet - Mediterranean: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
|---|---|---|
|
Proportion of Participants Who Are Weekly Responders Based on the Irritable Bowel Severity Scoring System (IBS-SSS) Modified Version for at Least 2 of the 4 Weeks
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline, 4 weeksPopulation: Results are based on a per-protocol analysis.
The modified version of the IBS-SSS was comprised of 5 questions participants answered based on their stomach and bowels. The total score for this modified version of the IBS-SSS was 0-500, with 0 indicating no IBS symptoms and 500 indicating the highest amount of IBS symptoms. The results represent the mean change from baseline minus 4 weeks.
Outcome measures
| Measure |
Diet Low in All FODMAP Groups
n=10 Participants
Diet low in all FODMAP groups: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
Diet - Mediterranean
n=10 Participants
Diet - Mediterranean: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
|---|---|---|
|
Change in Mean Score of the Irritable Bowel Severity Scoring System (IBS-SSS) Modified Version
|
-105.5 score on a scale
Interval -260.0 to -66.0
|
-60 score on a scale
Interval -227.0 to 57.0
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Results are based on a mITT analysis. Participants categorized in the Participant Flow as "Withdrawal by Subject" were not included in the mITT analysis.
Results reflect the number of participants who were weekly responders based on their abdominal bloating score for at least 2 of 4 weeks. The abdominal bloating score was a single-question, 11-point numeric rating scale in which 0 represented no abdominal bloating and 11 represented the worst possible abdominal bloating. Once per day, participants reported their worst daily (in the past 24 hours) abdominal bloating. A weekly responder was defined as a participant whose score decreased in the weekly average of worst bloating in the past 24 hours by at least 30% compared with baseline.
Outcome measures
| Measure |
Diet Low in All FODMAP Groups
n=11 Participants
Diet low in all FODMAP groups: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
Diet - Mediterranean
n=11 Participants
Diet - Mediterranean: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
|---|---|---|
|
Proportion of Participants Who Are Weekly Responders to Bloating for at Least 2 of the 4 Weeks
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Results are based on a mITT analysis. Participants categorized in the Participant Flow as "Withdrawal by Subject" were not included in the mITT analysis.
Results reflect the participants who were weekly responders based on their stool consistency assessment for at least 2 of 4 weeks. A stool consistency weekly responder was defined as a participant with a 50% or greater reduction in the number of days per week with at least one abnormal stool. Stools that scored as 1 or 2 (hard stool) or 6 or 7 (liquid stool) on the BSS were defined as abnormal.
Outcome measures
| Measure |
Diet Low in All FODMAP Groups
n=11 Participants
Diet low in all FODMAP groups: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
Diet - Mediterranean
n=11 Participants
Diet - Mediterranean: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
|---|---|---|
|
Participants Who Are Weekly Responders to Stool Consistency Based on the Bristol Stool Scale (BSS) for at Least 2 of the 4 Weeks
|
2 Participants
|
0 Participants
|
Adverse Events
Diet Low in All FODMAP Groups
Diet - Mediterranean
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diet Low in All FODMAP Groups
n=11 participants at risk
Diet low in all FODMAP groups: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
Diet - Mediterranean
n=15 participants at risk
Diet - Mediterranean: Randomized participants will eat this diet for 4 weeks (all meals and snacks will be provided). Participants will only eat the study food for this intervention. Participants will be asked to complete surveys, food diaries, and have blood and stools samples pre and post treatment.
|
|---|---|---|
|
Gastrointestinal disorders
Worsening Constipation
|
9.1%
1/11 • 4 weeks
|
0.00%
0/15 • 4 weeks
|
|
Gastrointestinal disorders
Worsening Abdominal Pain
|
0.00%
0/11 • 4 weeks
|
6.7%
1/15 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place