Trial Outcomes & Findings for Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth (NCT NCT01662791)
NCT ID: NCT01662791
Last Updated: 2016-08-04
Results Overview
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.
COMPLETED
PHASE3
49 participants
Baseline to 2 hours
2016-08-04
Participant Flow
Subjects were recruited at the Mayo Clinic in Scottsdale, Arizona.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Part 1 - Observational
STARTED
|
8
|
41
|
|
Part 1 - Observational
COMPLETED
|
8
|
41
|
|
Part 1 - Observational
NOT COMPLETED
|
0
|
0
|
|
Part 2 - Interventional
STARTED
|
8
|
0
|
|
Part 2 - Interventional
COMPLETED
|
8
|
0
|
|
Part 2 - Interventional
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial Overgrowth
Baseline characteristics by cohort
| Measure |
Case Group
n=8 Participants
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.
|
Control Group
n=41 Participants
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.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
41 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 hoursSBBO 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.
Outcome measures
| Measure |
Case Group
n=8 Participants
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.
|
Control Group
n=41 Participants
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.
|
|---|---|---|
|
Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO)
12 ppm increase
|
2 participants
|
12 participants
|
|
Number of Subjects With Small Bowel Bacterial Overgrowth (SBBO)
20 ppm increase
|
2 participants
|
9 participants
|
SECONDARY outcome
Timeframe: baselineThe 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.
Outcome measures
| Measure |
Case Group
n=8 Participants
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.
|
Control Group
n=41 Participants
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.
|
|---|---|---|
|
PD-specific Quality of Life Questionnaire (PDQ-39)
Mobility
|
23.1 units on a scale
Standard Deviation 20.1
|
14.0 units on a scale
Standard Deviation 17.6
|
|
PD-specific Quality of Life Questionnaire (PDQ-39)
Activities of Daily Living
|
25.0 units on a scale
Standard Deviation 14.1
|
18.1 units on a scale
Standard Deviation 13.3
|
|
PD-specific Quality of Life Questionnaire (PDQ-39)
Emotional Well-Being
|
17.2 units on a scale
Standard Deviation 23.5
|
13.2 units on a scale
Standard Deviation 11.5
|
|
PD-specific Quality of Life Questionnaire (PDQ-39)
Stigma
|
13.3 units on a scale
Standard Deviation 25.5
|
6.2 units on a scale
Standard Deviation 9.9
|
|
PD-specific Quality of Life Questionnaire (PDQ-39)
Social Support
|
3.1 units on a scale
Standard Deviation 6.2
|
1.4 units on a scale
Standard Deviation 4.9
|
|
PD-specific Quality of Life Questionnaire (PDQ-39)
Cognition
|
32.0 units on a scale
Standard Deviation 31.4
|
17.5 units on a scale
Standard Deviation 12.8
|
|
PD-specific Quality of Life Questionnaire (PDQ-39)
Communication
|
25.0 units on a scale
Standard Deviation 27.1
|
10.8 units on a scale
Standard Deviation 13.3
|
|
PD-specific Quality of Life Questionnaire (PDQ-39)
Bodily Discomfort
|
24.0 units on a scale
Standard Deviation 22.9
|
27.0 units on a scale
Standard Deviation 22.7
|
|
PD-specific Quality of Life Questionnaire (PDQ-39)
Summary Index
|
20.3 units on a scale
Standard Deviation 19.3
|
13.5 units on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsThe 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.
Outcome measures
| Measure |
Case Group
n=8 Participants
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.
|
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.
|
|---|---|---|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Mobility baseline
|
23.1 units on a scale
Standard Deviation 20.1
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Mobility 3 months
|
27.8 units on a scale
Standard Deviation 25.5
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Activities of Daily Living baseline
|
25.0 units on a scale
Standard Deviation 14.1
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Activities of Daily Living 3 months
|
17.7 units on a scale
Standard Deviation 17.8
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Emotional Well-Being baseline
|
17.2 units on a scale
Standard Deviation 23.5
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Emotional Well-Being 3 months
|
11.0 units on a scale
Standard Deviation 22.9
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Stigma baseline
|
13.3 units on a scale
Standard Deviation 25.5
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Stigma 3 months
|
5.5 units on a scale
Standard Deviation 11.3
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Social Support baseline
|
3.1 units on a scale
Standard Deviation 6.2
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Social Support 3 months
|
3.1 units on a scale
Standard Deviation 6.2
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Cognition baseline
|
32.0 units on a scale
Standard Deviation 31.4
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Cognition 3 months
|
21.9 units on a scale
Standard Deviation 16.7
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Communication baseline
|
25.0 units on a scale
Standard Deviation 27.1
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Communication 3 months
|
15.6 units on a scale
Standard Deviation 10.4
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Bodily Discomfort baseline
|
24.0 units on a scale
Standard Deviation 22.9
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Bodily Discomfort 3 months
|
30.2 units on a scale
Standard Deviation 31.2
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Summary Index baseline
|
20.3 units on a scale
Standard Deviation 19.3
|
—
|
|
PD-specific Quality of Life Questionnaire (PDQ-39) Over Time in Case Group
Summary Index 3 months
|
16.6 units on a scale
Standard Deviation 13.3
|
—
|
SECONDARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Case Group
n=8 Participants
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.
|
Control Group
n=41 Participants
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.
|
|---|---|---|
|
Gastrointestinal Symptom Severity Index (GISSI)
Constipation
|
22.6 units on a scale
Standard Deviation 20.8
|
14.5 units on a scale
Standard Deviation 15.8
|
|
Gastrointestinal Symptom Severity Index (GISSI)
Dyspepsia
|
7.2 units on a scale
Standard Deviation 11.5
|
4.5 units on a scale
Standard Deviation 6.6
|
|
Gastrointestinal Symptom Severity Index (GISSI)
Abdominal Pain/Discomfort
|
8.1 units on a scale
Standard Deviation 16.5
|
6.6 units on a scale
Standard Deviation 10.2
|
|
Gastrointestinal Symptom Severity Index (GISSI)
Diarrhea
|
3.4 units on a scale
Standard Deviation 4.9
|
2.7 units on a scale
Standard Deviation 6.2
|
|
Gastrointestinal Symptom Severity Index (GISSI)
GERD
|
5.6 units on a scale
Standard Deviation 10.6
|
3.4 units on a scale
Standard Deviation 5.2
|
|
Gastrointestinal Symptom Severity Index (GISSI)
Nausea/Vomiting
|
1.6 units on a scale
Standard Deviation 3.1
|
0.63 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: baseline, 3 monthsThe 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.
Outcome measures
| Measure |
Case Group
n=8 Participants
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.
|
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.
|
|---|---|---|
|
Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
Constipation baseline
|
32.3 units on a scale
Standard Deviation 29.8
|
—
|
|
Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
Constipation 3 months
|
10.0 units on a scale
Standard Deviation 10.6
|
—
|
|
Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
Dyspepsia baseline
|
12.9 units on a scale
Standard Deviation 20.6
|
—
|
|
Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
Dyspepsia 3 months
|
8.2 units on a scale
Standard Deviation 15.5
|
—
|
|
Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
Abdominal Pain/Discomfort baseline
|
14.5 units on a scale
Standard Deviation 29.4
|
—
|
|
Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
Abdominal Pain/Discomfort 3 months
|
4.0 units on a scale
Standard Deviation 7.5
|
—
|
|
Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
Diarrhea baseline
|
6.0 units on a scale
Standard Deviation 8.7
|
—
|
|
Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
Diarrhea 3 months
|
12.7 units on a scale
Standard Deviation 19.8
|
—
|
|
Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
GERD baseline
|
10.0 units on a scale
Standard Deviation 18.9
|
—
|
|
Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
GERD 3 months
|
8.5 units on a scale
Standard Deviation 12.9
|
—
|
|
Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
Nausea/Vomiting baseline
|
5.8 units on a scale
Standard Deviation 11.1
|
—
|
|
Gastrointestinal Symptom Severity Index (GISSI) Over Time in Case Group
Nausea/Vomiting 3 months
|
2.2 units on a scale
Standard Deviation 6.3
|
—
|
SECONDARY outcome
Timeframe: BaselineThe 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
Outcome measures
| Measure |
Case Group
n=8 Participants
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.
|
Control Group
n=41 Participants
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.
|
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
Depression
|
3.5 units on a scale
Standard Deviation 3.7
|
3.3 units on a scale
Standard Deviation 2.1
|
|
Hospital Anxiety and Depression Scale (HADS)
Anxiety
|
3.8 units on a scale
Standard Deviation 3.8
|
4.0 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: baseline, 3 monthsWeight change after treatment
Outcome measures
| Measure |
Case Group
n=8 Participants
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.
|
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.
|
|---|---|---|
|
Weight Change in Case Group After Treatment
Subjects who lost weight from baseline
|
3 participants
|
—
|
|
Weight Change in Case Group After Treatment
Subjects who gained weight from baseline
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Case Group
n=8 Participants
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.
|
Control Group
n=41 Participants
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.
|
|---|---|---|
|
Paffenbarger Physical Activity Questionnaire (PPAQ)
|
848.8 kcal/week
Standard Deviation 566.5
|
2253 kcal/week
Standard Deviation 2027
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineThe 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.
Outcome measures
| Measure |
Case Group
n=8 Participants
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.
|
Control Group
n=41 Participants
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.
|
|---|---|---|
|
Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ)
Total calories consumed
|
1503.7 Calories
Standard Deviation 395.6
|
1588.0 Calories
Standard Deviation 538.7
|
|
Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ)
Fat
|
36.3 Calories
Standard Deviation 9.6
|
38.0 Calories
Standard Deviation 6.5
|
|
Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ)
Saturated Fat
|
12.7 Calories
Standard Deviation 3.8
|
13.0 Calories
Standard Deviation 3.0
|
|
Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ)
Protein
|
13.4 Calories
Standard Deviation 3.1
|
15.7 Calories
Standard Deviation 3.4
|
|
Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ)
Carbohydrate
|
45.1 Calories
Standard Deviation 7.6
|
43.7 Calories
Standard Deviation 6.9
|
|
Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ)
Alcohol
|
14.8 Calories
Standard Deviation 9.3
|
12.5 Calories
Standard Deviation 8.8
|
|
Calories Consumed From Brief Block Food Frequency Questionnaire (FFQ)
Sweets
|
10.9 Calories
Standard Deviation 15.3
|
6.5 Calories
Standard Deviation 7.1
|
Adverse Events
Case Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Case Group
n=8 participants at risk
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.
|
Control Group
n=41 participants at risk
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.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/8
|
2.4%
1/41 • Number of events 1
|
|
Gastrointestinal disorders
Loose stool
|
12.5%
1/8 • Number of events 1
|
0.00%
0/41
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1
|
0.00%
0/41
|
|
Musculoskeletal and connective tissue disorders
Shoulder joint repair
|
12.5%
1/8 • Number of events 1
|
0.00%
0/41
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place