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| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
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The purpose of this study is to determine how certain types of bacteria in the human gut may affect weight gain, and contribute to the development of diabetes.
The investigators initial studies have shown that gut bacteria that produce methane may directly affect weight gain. These bacteria, called methanogens, produce methane gas as a byproduct, which can be detected through breath testing. Methane can slow the passage of food through the intestines, which would allow extra time for uptake and absorption of nutrients and calories, and might contribute to weight gain. The investigators have also found that people who have increased levels of methane-producing bacteria in their intestines also have higher levels of glucose in their blood. Therefore, control of how the body responds to insulin and uses glucose may be altered in methane-producing individuals.
This research study is designed to test the investigational use of the drugs neomycin and rifaximin that have been approved by the U.S Food and Drug Administration (FDA). While neomycin is FDA-approved for treating skin infections, preparing the bowel for surgery, and hepatic encephalopathy (a condition that occurs when a damaged liver cannot remove the toxins that a healthy liver normally would), and rifaximin is FDA-approved for treating travelers' diarrhea, they are not yet approved to be used together for the treatment of methanogens or obesity.
Pre-diabetes is defined by impaired fasting glucose (IFG) and/or impaired glucose tolerance (IGT) and affects more than 40% of US adults. While glycemic dysregulation and insulin resistance are central to the progression from pre-diabetes to diabetes, obesity also plays a key role. Research has begun to define the relationship between gut flora, metabolism and weight gain. Animal studies have linked a specific methanogen, Methanobrevibacter smithii, to weight gain, and in humans we have found that increased methane on breath test is associated both with increased body mass index (BMI) and higher blood glucose levels. We also found that methane gas directly slows gut transit by 59% in an in vivo animal model. We hypothesize that this slowing of transit could result in a greater time to harvest nutrients and absorb calories, representing a potential mechanism for elevated post-prandial glycemic excursions and weight gain. In this study, we will test this hypothesis by determining the effects of enteric methane production on glucose excursions, gut transit and energy utilization in obese or overweight, prediabetic, adult subjects.
We will explore the relationship between methane, M. smithii, obesity and gut transit in human subjects using objective measures of metabolic function, glucose excursions, energy utilization and transit studies, to evaluate whether intestinal methane production is associated with a higher incidence of diabetes risk in an obese study population. We will then repeat testing following a course of antibiotics known to eliminate methanogens. This will potentially provide novel therapies for the pre-diabetic patient, and allow new avenues for research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese/overweight, prediabetic methane positive | Experimental | Neomycin Rifaximin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neomycin | Drug | Neomycin: 500mg po bid for 10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Eradicated Methane on Breath Test | Number of subjects who exhibited a decrease in breath methane levels to below detectable (below 3ppm) following antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment breath tests were performed within 2 weeks (14 days) of completing the course of antibiotics. | Baseline and 1-14 days following completion of antibiotic treatment |
| Stool Methanogen Levels | Stool methanogen levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment stool samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3) | Baseline and 1-60 days following completion of antibiotic treatment |
| Stool Total Bacteria Levels | Stool total bacteria levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics.Post-treatment stool samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3) | Baseline and 1-60 days following completion of antibiotic treatment |
| Low Density Lipoprotein (LDL) Levels Before and After Antibiotic Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Bowel Symptoms - Bloating | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) |
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Inclusion Criteria:
Exclusion Criteria:
Subjects will be excluded from the study if they exhibit any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Ruchi Mathur, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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A total of 12 subjects were consented to participate. 1 subject withdrew prior to completing the study.
Study was open for recruitment from April 12, 2012 - Dec 31, 2013 Setting: Tertiary care center
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| ID | Title | Description |
|---|---|---|
| FG000 | Obese/Overweight, Prediabetic Methane Positive Subjects | Neomycin Rifaximin Neomycin: Neomycin: 500mg po bid for 10 days Rifaximin: Rifaximin: 550mg po tid for 10 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Obese/Overweight, Prediabetic Methane Positive Subjects | Neomycin Rifaximin Neomycin: Neomycin: 500mg po bid for 10 days Rifaximin: Rifaximin: 550mg po tid for 10 days |
| 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 Who Eradicated Methane on Breath Test | Number of subjects who exhibited a decrease in breath methane levels to below detectable (below 3ppm) following antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment breath tests were performed within 2 weeks (14 days) of completing the course of antibiotics. | Posted | Number | participants | Baseline and 1-14 days following completion of antibiotic treatment |
|
|
20 months
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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 | Obese/Overweight, Prediabetic Methane Positive Subjects | Neomycin Rifaximin Neomycin: Neomycin: 500mg po bid for 10 days Rifaximin: Rifaximin: 550mg po tid for 10 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Loose stool | Gastrointestinal disorders | Non-systematic Assessment | 2 subjects reported looser stools than normal after taking the study antibiotics. Loose stool is a known potential side effect of the antibiotics used in the study. Stool cutures were performed and were negative. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ruchi Mathur | Cedars-Sinai Medical Center | 310-423-4774 | Ruchi.Mathur@cshs.org |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D009355 | Neomycin |
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D012294 | Rifamycins |
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| Rifaximin |
| Drug |
Rifaximin: 550mg po tid for 10 days |
|
LDL levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment blood samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3) |
| Baseline and 1-60 days following completion of antibiotic treatment |
| Total Cholesterol Levels Before and After Antibiotic Therapy | Total cholesterol levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics.Post-treatment blood samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3) | Baseline and 1-60 days following completion of antibiotic treatment |
| Average Daily Caloric Loss in Stool | The daily caloric loss in stool for each subject was calculated by expressing the total number of kcalories lost in stool over a 3-day period as a percentage of the total number of kcalories ingested over the same 3 days (the number of calories ingested = the number available in meals provided less the number remaining in leftovers). Caloric content for meals, leftovers, and stool was determined by bomb calorimetry. This average daily caloric loss for each group was then compared before and after antibiotic therapy. Post-treatment caloric harvest studies were performed within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Baseline and 1-60 days following completion of antibiotic treatment |
| Gastric Emptying | Gastric Emptying times (minutes) were determined in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment gastric emptying studies were performed within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Baseline and 1-60 days following completion of antibiotic treatment |
| Baseline and 1-60 days following completion of antibiotic treatment |
| Bowel Symptoms - Abdominal Pain | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Baseline and 1-60 days following completion of antibiotic treatment |
| Bowel Symptoms - Constipation | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Baseline and 1-60 days following completion of antibiotic treatment |
| Bowel Symptoms - Diarrhea | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Baseline and 1-60 days following completion of antibiotic treatment |
| Bowel Symptoms - Straining | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Baseline and 1-60 days following completion of antibiotic treatment |
| % Stool Dry Weight | % stool dry weight [total stool dry weight (g)/total stool fresh weight (g)] was determined in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment stool samples were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Baseline and 1-60 days following completion of antibiotic treatment |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| A1c (%) | Mean | Standard Deviation | Percent |
|
| Participants |
|
|
| Primary | Stool Methanogen Levels | Stool methanogen levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment stool samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3) | Posted | Mean | Standard Deviation | colony forming units | Baseline and 1-60 days following completion of antibiotic treatment |
|
|
|
|
| Primary | Stool Total Bacteria Levels | Stool total bacteria levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics.Post-treatment stool samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3) | Posted | Mean | Standard Deviation | colony forming units | Baseline and 1-60 days following completion of antibiotic treatment |
|
|
|
| Primary | Low Density Lipoprotein (LDL) Levels Before and After Antibiotic Therapy | LDL levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment blood samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3) | Posted | Mean | Standard Deviation | mg/dL | Baseline and 1-60 days following completion of antibiotic treatment |
|
|
|
|
| Primary | Total Cholesterol Levels Before and After Antibiotic Therapy | Total cholesterol levels were measured in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics.Post-treatment blood samples were collected within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Methane Eradicators (subjects who eradicated methane on breath test following antibiotic treatment) (N=8) Group 2 - Methane Non-eradicators (subjects who did not eradicate methane on breath test following antibiotic treatment) (N=3) | Posted | Mean | Standard Deviation | mg/dL | Baseline and 1-60 days following completion of antibiotic treatment |
|
|
|
|
| Primary | Average Daily Caloric Loss in Stool | The daily caloric loss in stool for each subject was calculated by expressing the total number of kcalories lost in stool over a 3-day period as a percentage of the total number of kcalories ingested over the same 3 days (the number of calories ingested = the number available in meals provided less the number remaining in leftovers). Caloric content for meals, leftovers, and stool was determined by bomb calorimetry. This average daily caloric loss for each group was then compared before and after antibiotic therapy. Post-treatment caloric harvest studies were performed within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Posted | Mean | Standard Deviation | %kcal lost | Baseline and 1-60 days following completion of antibiotic treatment |
|
|
|
|
| Primary | Gastric Emptying | Gastric Emptying times (minutes) were determined in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment gastric emptying studies were performed within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Posted | Mean | Standard Deviation | minutes | Baseline and 1-60 days following completion of antibiotic treatment |
|
|
|
|
| Secondary | Bowel Symptoms - Bloating | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Posted | Mean | Standard Deviation | 0-100mm visual analogue scale | Baseline and 1-60 days following completion of antibiotic treatment |
|
|
|
|
| Secondary | Bowel Symptoms - Abdominal Pain | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Posted | Mean | Standard Deviation | 0-100mm visual analogue scale | Baseline and 1-60 days following completion of antibiotic treatment |
|
|
|
|
| Secondary | Bowel Symptoms - Constipation | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Posted | Mean | Standard Deviation | 0-100mm visual analogue scale | Baseline and 1-60 days following completion of antibiotic treatment |
|
|
|
|
| Secondary | Bowel Symptoms - Diarrhea | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Posted | Mean | Standard Deviation | 0-100mm visual analogue scale | Baseline and 1-60 days following completion of antibiotic treatment |
|
|
|
|
| Secondary | Bowel Symptoms - Straining | Bowel symptom scores on a visual analog scale (VAS) were compared in all subjects before and after antibiotic treatment. Scale values were from 0 to 100, where 0 indicates no symptom and 100 indicates severe symptoms. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment symptom scores were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Posted | Mean | Standard Deviation | 0-100mm visual analogue scale | Baseline and 1-60 days following completion of antibiotic treatment |
|
|
|
|
| Secondary | % Stool Dry Weight | % stool dry weight [total stool dry weight (g)/total stool fresh weight (g)] was determined in all subjects before and after antibiotic treatment. After baseline (pre-treatment) testing, subjects underwent a 10-day course of antibiotics. Post-treatment stool samples were obtained within 31 days (1 month) of completing the course of antibiotics. One subject received an exemption from this requirement and completed testing within 60 days. For analysis, subjects were grouped into two groups: Group 1 - Total study population (methane eradicators and non-eradicators, N=11) Group 2 - Methane eradicators (subjects who eradicated methane on breath test following antibiotic treatment, N=8) | Posted | Mean | Standard Deviation | % stool dry weight | Baseline and 1-60 days following completion of antibiotic treatment |
|
|
|
|
| 0 |
| 11 |
| 2 |
| 11 |
|
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006576 |
| Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| 0.85 |
| Superiority or Other |
| 0.45 |
| Superiority or Other |
| 0.14 |
| Superiority or Other |
| 0.44 |
| Superiority or Other |
| 0.25 |
| Superiority or Other |
| 0.27 |
| Superiority or Other |
| 0.059 |
| Superiority or Other |
| 0.075 |
| Superiority or Other |