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| Name | Class |
|---|---|
| Hong Kong Association for Health Care | UNKNOWN |
| Integrated Chinese Medicine Holdings | UNKNOWN |
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The purpose of this study is to compare and contrast the effects of a prebiotic (Trametes Versicolor), a probiotic (Saccharomyces boulardii) and an antibiotic (amoxicillin) on the gut microbiota of healthy volunteers. It is expected that treatment will result in the rapid and reproducible alterations in fecal microbiota that will spontaneously reverse in the weeks after treatment is discontinued.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prebiotic | Active Comparator |
| |
| Probiotic | Active Comparator |
| |
| Antibiotic | Active Comparator |
| |
| Control | No Intervention | Control group, no intervention given. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trametes versicolor extract | Dietary Supplement | 1,200 mg, 3 times daily on an empty stomach for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacteria Prevalence in Stool | The most prevalent bacterial genera within the study population Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Days 10 and 14 After Treatment: Average of Days 21, 28, and 56 | Day 0 to 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ciaran P Kelly, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prebiotic | Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days |
| FG001 | Probiotic | Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days |
| FG002 | Antibiotic | Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days |
| FG003 | Control | Control group, no intervention given. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prebiotic | Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days |
| BG001 | Probiotic | Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Bacteria Prevalence in Stool | The most prevalent bacterial genera within the study population Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Days 10 and 14 After Treatment: Average of Days 21, 28, and 56 | The investigators expanded their studies on the probiotic (Saccharomyces boulardii) to constitute a full, separate study. Reference: NCT01473368. | Posted | Mean | Standard Deviation | percentage of bacterial genera in stool | Day 0 to 56 |
|
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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 | Prebiotic | Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Soft stool | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ciaran Kelly, MD | Beth Israel Deaconess Medical Center | 617-667-1272 | ckelly2@bidmc.harvard.edu |
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| ID | Term |
|---|---|
| C504606 | VPS Coriolus versicolor extract |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 |
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| Saccharomyces boulardii | Dietary Supplement | 250 mg, 3 times daily on an empty stomach for 14 days |
|
| Amoxicillin | Drug | 250 mg 3 times daily at least 1 hour before meals for 7 days |
|
| BG002 | Antibiotic | Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days |
| BG003 | Control | Control group, no intervention given. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Amoxicillin - After Treatment | Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days |
| OG003 | Control | Control group - no intervention given. |
| OG004 | Trametes Versicolor Extract - Before Treatment | Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days |
| OG005 | Trametes Versicolor Extract - During Treatment | Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days |
| OG006 | Trametes Versicolor Extract - After Treatment | Trametes versicolor extract: 1,200 mg, 3 times daily on an empty stomach for 14 days |
| OG007 | Saccharomyces Boulardii - Before Treatment | Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days |
| OG008 | Saccharomyces Boulardii - During Treatment | Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days |
| OG009 | Saccharomyces Boulardii - After Treatment | Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days |
|
|
|
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Probiotic | Saccharomyces boulardii: 250 mg, 3 times daily on an empty stomach for 14 days | 0 | 8 | 0 | 8 |
| EG002 | Antibiotic | Amoxicillin: 250 mg 3 times daily at least 1 hour before meals for 7 days | 0 | 8 | 2 | 8 |
| EG003 | Control | Control group, no intervention given. | 0 | 8 | 0 | 8 |
| gas | Gastrointestinal disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |