| Primary | Proportion of Participants Who Are Responders Based on the Abdominal Pain Intensity Score for at Least 2 of 4 Weeks | 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. | 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. | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Fisher Exact | | 1.00 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Proportion of Participants Who Are Weekly Responders to Adequate Relief Symptom Assessment for at Least 2 of 4 Weeks | 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. | Results are based on a mITT analysis. Participants categorized in the Participant Flow as "Withdrawal by Subject" were not included in the mITT analysis. | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | 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 | 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. | Results are based on a mITT analysis. Participants categorized in the Participant Flow as "Withdrawal by Subject" were not included in the mITT analysis. | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Change in Mean Score of the Irritable Bowel Severity Scoring System (IBS-SSS) Modified Version | 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. | Results are based on a per-protocol analysis. | Posted | | Mean | 95% Confidence Interval | score on a scale | | Baseline, 4 weeks | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Proportion of Participants Who Are Weekly Responders to Bloating for at Least 2 of the 4 Weeks | 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. | Results are based on a mITT analysis. Participants categorized in the Participant Flow as "Withdrawal by Subject" were not included in the mITT analysis. | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Secondary | Participants Who Are Weekly Responders to Stool Consistency Based on the Bristol Stool Scale (BSS) for at Least 2 of the 4 Weeks | 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. | Results are based on a mITT analysis. Participants categorized in the Participant Flow as "Withdrawal by Subject" were not included in the mITT analysis. | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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