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The potential role of small bowel bacterial overgrowth (SBBO) in weight loss occurring in patients with Parkinson's Disease (PD) has not previously been examined. Our hypothesis was that SBBO is an important contributor to the development of weight loss in individuals with PD. The investigators proposed to 1) examine the role of SBBO in weight loss occurring in patients with PD and 2) determine the response to its treatment with a poorly absorbed antibiotic. The investigators performed a prospective, observational case-control study (Part 1) with an open-label therapeutic component (Part 2). Cases were defined as those PD patients who experienced significant weight loss while Controls were defined as those PD patients who did not experience significant weight loss.
Part 1:
Consecutive patients seen in the Parkinson's disease clinic at Mayo Clinic in Arizona were approached to participate. After the determination of their eligibility and appropriate signed informed consent, all PD patients (i.e., both Case and Control groups) underwent the following:
All questionnaires were completed during the 2 hour breath test.
Part 2:
All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO twice a day for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects could have received antibiotic treatment. The patient was contacted by phone 1 month after treatment at which time the presence of GI symptoms was determined and inquiry made about any adverse effects related to rifaximin use. GI symptoms, quality of life, weight measurement, and breath testing were repeated at a 3 month study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case Group | Experimental | All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO twice a day (BID) for 14 days. Subjects in the case group were in the study for 3 months. |
|
| Control Group | No Intervention | This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin | Drug | All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment will not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO) | SBBO is measured by the Hydrogen Breath Test, which measures the hydrogen and methane gas produced by bacteria in the small bowel that has diffused into the blood, then lungs for expiration. After an overnight fast, subjects ingested a solution consisting of 50 grams of glucose mixed in 150 mL of water. Immediately before ingestion of glucose and at 20-minute intervals for 2 hours following ingestion, laboratory staff collected end-expiratory breath samples and analyzed them for hydrogen and methane using a Quintron sample correction (SC) breath microlyzer. A diagnosis of SBBO was defined by an increase in expiration of 12 parts per million (ppm) or more of hydrogen and/or methane. | Baseline to 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| PD-specific Quality of Life Questionnaire (PDQ-39) | The PDQ-39 is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. This questionnaire is based on a multi-dimensional model of health. Eight subscale scores may be derived from the items: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert Scale): Never/occasionally/sometimes/often/always or cannot do at all. Each dimension is calculated as a scale from 0 to 100, with 0= no problem at all; 100= maximum level of problem. Sub-scale score are averaged to calculate the summary index. |
| Measure | Description | Time Frame |
|---|---|---|
| Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ) | The FFQ is a validated, self-administered semi-quantitative questionnaire used to assess differences in macronutrient, and energy intake. It was designed to provide estimates of usual and customary dietary intake. This questionnaire contains a food list of about 70 food items. A Food Frequency Questionnaire (FFQ) is a limited checklist of foods and beverages with a frequency response section for subjects to report how often each item was consumed over a specified period of time. Semi-quantitative FFQs collect portion size information as standardized portions or as a choice of portion sizes. Calculations for nutrient intake or calories can be estimated via computerized software programs that multiply the reported frequency of each food by the amount of nutrient or calories in a serving of that food. |
Inclusion criteria: Parkinson's Disease
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Di Baise, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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Subjects were recruited at the Mayo Clinic in Scottsdale, Arizona.
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| ID | Title | Description |
|---|---|---|
| FG000 | Case Group | All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO twice a day (BID) for 14 days. Subjects in the case group were in the study for 3 months. Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment. |
| FG001 | Control Group | This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day; they did not take part in the second part of the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1 - Observational |
| |||||||||||||
| Part 2 - Interventional |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Case Group | All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months. Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO) | SBBO is measured by the Hydrogen Breath Test, which measures the hydrogen and methane gas produced by bacteria in the small bowel that has diffused into the blood, then lungs for expiration. After an overnight fast, subjects ingested a solution consisting of 50 grams of glucose mixed in 150 mL of water. Immediately before ingestion of glucose and at 20-minute intervals for 2 hours following ingestion, laboratory staff collected end-expiratory breath samples and analyzed them for hydrogen and methane using a Quintron sample correction (SC) breath microlyzer. A diagnosis of SBBO was defined by an increase in expiration of 12 parts per million (ppm) or more of hydrogen and/or methane. | Posted | Number | participants | Baseline to 2 hours |
|
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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 | Case Group | All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months. Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John K. DiBaise | Mayo Clinic | 480-301-6990 | DiBaise.John@mayo.edu |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| baseline |
| PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group | The PDQ-39 is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. This questionnaire is based on a multi-dimensional model of health. Eight subscale scores may be derived from the items: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert Scale): Never/occasionally/sometimes/often/always or cannot do at all. Each dimension is calculated as a scale from 0 to 100, with 0= no problem at all; 100= maximum level of problem. Sub-scale score are averaged to calculate the summary index. | Baseline and 3 months |
| Gastrointestinal Symptom Severity Index (GISSI) | The GISSI is a validated, self-administered, multi-dimensional instrument designed to measure the frequency, severity and bothersomeness of individual GI symptoms and to provide subscale scores for interrelated symptom clusters. Factor analyses yielded 5 distinct symptom clusters that were labeled as Constipation/Difficult defecation; Abdominal Pain/Discomfort; Dyspepsia; Diarrhea/Fecal incontinence; Gastroesophageal reflux disease (GERD)/Chest symptoms; and Nausea/Vomiting. Scores could range from 0 to 100, with a higher score indicating greater severity of symptoms. | Baseline |
| Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group | The GISSI is a validated, self-administered, multi-dimensional instrument designed to measure the frequency, severity and bothersomeness of individual GI symptoms and to provide subscale scores for interrelated symptom clusters. Factor analyses yielded 5 distinct symptom clusters that were labeled as Constipation/Difficult defecation; Abdominal Pain/Discomfort; Dyspepsia; Diarrhea/Fecal incontinence; Gastroesophageal reflux disease (GERD)/Chest symptoms; and Nausea/Vomiting. Scores could range from 0 to 100, with a higher score indicating greater severity of symptoms. | baseline, 3 months |
| Hospital Anxiety and Depression Scale (HADS) | The HADS is a self-administered 14-item questionnaire (seven for anxiety and seven for depression) Items are rated on a 4-point scale from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. The cut-offs used for identifying significant psychiatric distress was >/= 8. This assessment was only measured at baseline | Baseline |
| Weight Change in Case Group After Treatment | Weight change after treatment | baseline, 3 months |
| Paffenbarger Physical Activity Questionnaire (PPAQ) | The PPAQ is a validated, self-administered questionnaire that asks for a recall of physical activity of physical activity over the previous 1-week. From the answers to the questions, a physical activity index (PAI) can be computed, providing an estimate of energy expenditure in kcal/week. The PAI can be estimated using a list of the physical activities a person performs within a time period and the amount of time spent on each activity, e.g. walking to work, light housework, swimming, carrying bricks at work, or whatever applies to an individual person. There is a value called the physical activity ratio for each activity. The list of activities is used to find the relevant values of physical activity ratios, then an overall physical activity level value for the time period is calculated, using time-weighted averages of the physical activity ratios. This assessment was only measured at baseline. | Baseline |
| Baseline |
| NOT COMPLETED |
|
| BG001 | Control Group | This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control Group | This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day. |
|
|
|
| Secondary | PD-specific Quality of Life Questionnaire (PDQ-39) | The PDQ-39 is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. This questionnaire is based on a multi-dimensional model of health. Eight subscale scores may be derived from the items: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert Scale): Never/occasionally/sometimes/often/always or cannot do at all. Each dimension is calculated as a scale from 0 to 100, with 0= no problem at all; 100= maximum level of problem. Sub-scale score are averaged to calculate the summary index. | Posted | Mean | Standard Deviation | units on a scale | baseline |
|
|
|
|
| Secondary | PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group | The PDQ-39 is designed to address aspects of functioning and well-being for those affected by Parkinson's disease. This questionnaire is based on a multi-dimensional model of health. Eight subscale scores may be derived from the items: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communication (3 items), bodily discomfort (3 items). Patients are asked to think about their health and general well-being and to consider how often in the last month they have experienced certain events (e.g. difficulty walking 100 yards). Patients are asked to indicate the frequency of each event by selecting one of 5 options (Likert Scale): Never/occasionally/sometimes/often/always or cannot do at all. Each dimension is calculated as a scale from 0 to 100, with 0= no problem at all; 100= maximum level of problem. Sub-scale score are averaged to calculate the summary index. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 months |
|
|
|
|
| Secondary | Gastrointestinal Symptom Severity Index (GISSI) | The GISSI is a validated, self-administered, multi-dimensional instrument designed to measure the frequency, severity and bothersomeness of individual GI symptoms and to provide subscale scores for interrelated symptom clusters. Factor analyses yielded 5 distinct symptom clusters that were labeled as Constipation/Difficult defecation; Abdominal Pain/Discomfort; Dyspepsia; Diarrhea/Fecal incontinence; Gastroesophageal reflux disease (GERD)/Chest symptoms; and Nausea/Vomiting. Scores could range from 0 to 100, with a higher score indicating greater severity of symptoms. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
|
| Secondary | Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group | The GISSI is a validated, self-administered, multi-dimensional instrument designed to measure the frequency, severity and bothersomeness of individual GI symptoms and to provide subscale scores for interrelated symptom clusters. Factor analyses yielded 5 distinct symptom clusters that were labeled as Constipation/Difficult defecation; Abdominal Pain/Discomfort; Dyspepsia; Diarrhea/Fecal incontinence; Gastroesophageal reflux disease (GERD)/Chest symptoms; and Nausea/Vomiting. Scores could range from 0 to 100, with a higher score indicating greater severity of symptoms. | Posted | Mean | Standard Deviation | units on a scale | baseline, 3 months |
|
|
|
|
| Secondary | Hospital Anxiety and Depression Scale (HADS) | The HADS is a self-administered 14-item questionnaire (seven for anxiety and seven for depression) Items are rated on a 4-point scale from 0-3 and this means that a person can score between 0 (no symptoms) and 21 (severe symptoms) for either anxiety or depression. The cut-offs used for identifying significant psychiatric distress was >/= 8. This assessment was only measured at baseline | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
|
| Other Pre-specified | Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ) | The FFQ is a validated, self-administered semi-quantitative questionnaire used to assess differences in macronutrient, and energy intake. It was designed to provide estimates of usual and customary dietary intake. This questionnaire contains a food list of about 70 food items. A Food Frequency Questionnaire (FFQ) is a limited checklist of foods and beverages with a frequency response section for subjects to report how often each item was consumed over a specified period of time. Semi-quantitative FFQs collect portion size information as standardized portions or as a choice of portion sizes. Calculations for nutrient intake or calories can be estimated via computerized software programs that multiply the reported frequency of each food by the amount of nutrient or calories in a serving of that food. | Posted | Mean | Standard Deviation | Calories | Baseline |
|
|
|
| Secondary | Weight Change in Case Group After Treatment | Weight change after treatment | Posted | Number | participants | baseline, 3 months |
|
|
|
| Secondary | Paffenbarger Physical Activity Questionnaire (PPAQ) | The PPAQ is a validated, self-administered questionnaire that asks for a recall of physical activity of physical activity over the previous 1-week. From the answers to the questions, a physical activity index (PAI) can be computed, providing an estimate of energy expenditure in kcal/week. The PAI can be estimated using a list of the physical activities a person performs within a time period and the amount of time spent on each activity, e.g. walking to work, light housework, swimming, carrying bricks at work, or whatever applies to an individual person. There is a value called the physical activity ratio for each activity. The list of activities is used to find the relevant values of physical activity ratios, then an overall physical activity level value for the time period is calculated, using time-weighted averages of the physical activity ratios. This assessment was only measured at baseline. | Posted | Mean | Standard Deviation | kcal/week | Baseline |
|
|
|
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Control Group | This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day. | 0 | 41 | 1 | 41 |
| Loose stool | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Shoulder joint repair | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
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Not provided
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| Emotional Well-Being |
|
| Stigma |
|
| Social Support |
|
| Cognition |
|
| Communication |
|
| Bodily Discomfort |
|
| Summary Index |
|
| 0.206 |
| No |
| Superiority or Other |
| Comparison between groups for emotional well-being sub-scale. | Chi-squared | 0.641 | No | Superiority or Other |
| Comparison between groups for stigma sub-scale. | Chi-squared | 0.446 | No | Superiority or Other |
| Comparison between groups for social support sub-scale. | Chi-squared | 0.466 | No | Superiority or Other |
| Comparison between groups for cognition sub-scale. | Chi-squared | 0.205 | No | Superiority or Other |
| Comparison between groups for communication sub-scale. | Chi-squared | 0.153 | No | Superiority or Other |
| Comparison between groups for bodily discomfort sub-scale. | Chi-squared | 0.730 | No | Superiority or Other |
| Comparison between groups for summary index sub-scale. | Chi-squared | 0.334 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Activities of Daily Living 3 months |
|
| Emotional Well-Being baseline |
|
| Emotional Well-Being 3 months |
|
| Stigma baseline |
|
| Stigma 3 months |
|
| Social Support baseline |
|
| Social Support 3 months |
|
| Cognition baseline |
|
| Cognition 3 months |
|
| Communication baseline |
|
| Communication 3 months |
|
| Bodily Discomfort baseline |
|
| Bodily Discomfort 3 months |
|
| Summary Index baseline |
|
| Summary Index 3 months |
|
| 0.159 |
| No |
| Superiority or Other |
| Comparison in case group between baseline and 3 months for emotional well-being sub-scale. | McNemar | 0.041 | No | Superiority or Other |
| Comparison in case group between baseline and 3 months for stigma sub-scale. | McNemar | 0.190 | No | Superiority or Other |
| Comparison in case group between baseline and 3 months for social support sub-scale. | McNemar | 1.0 | No | Superiority or Other |
| Comparison in case group between baseline and 3 months for cognition sub-scale. | McNemar | 0.160 | No | Superiority or Other |
| Comparison in case group between baseline and 3 months for communication sub-scale. | McNemar | 0.276 | No | Superiority or Other |
| Comparison in case group between baseline and 3 months for bodily discomfort sub-scale. | McNemar | 0.351 | No | Superiority or Other |
| Comparison in case group between baseline and 3 months for summary index sub-scale. | McNemar | 0.186 | No | Superiority or Other |
| Abdominal Pain/Discomfort |
|
| Diarrhea |
|
| GERD |
|
| Nausea/Vomiting |
|
| 0.518 |
| No |
| Superiority or Other |
| Comparison between groups for abdominal discomfort sub-scale. | Chi-squared | 0.800 | No | Superiority or Other |
| Comparison between groups for diarrhea sub-scale. | Chi-squared | 0.736 | No | Superiority or Other |
| Comparison between groups for GERD sub-scale. | Chi-squared | 0.570 | No | Superiority or Other |
| Comparison between groups for nausea and vomiting sub-scale. | Chi-squared | 0.394 | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Dyspepsia 3 months |
|
| Abdominal Pain/Discomfort baseline |
|
| Abdominal Pain/Discomfort 3 months |
|
| Diarrhea baseline |
|
| Diarrhea 3 months |
|
| GERD baseline |
|
| GERD 3 months |
|
| Nausea/Vomiting baseline |
|
| Nausea/Vomiting 3 months |
|
| 0.380 |
| No |
| Superiority or Other |
| Comparison in case group between baseline and 3 months for abdominal discomfort sub-scale. | McNemar | 0.244 | No | Superiority or Other |
| Comparison in case group between baseline and 3 months for diarrhea sub-scale. | McNemar | 0.279 | No | Superiority or Other |
| Comparison in case group between baseline and 3 months for GERD sub-scale. | McNemar | 0.554 | No | Superiority or Other |
| Comparison in case group between baseline and 3 months for nausea and vomiting sub-scale. | McNemar | 0.351 | No | Superiority or Other |
| 0.835 |
| 2-Sided |
| No |
| Superiority or Other |
| Saturated Fat |
|
| Protein |
|
| Carbohydrate |
|
| Alcohol |
|
| Sweets |
|