Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Biocodex | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare and contrast the effects of the probiotic Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the gut microbiota of healthy volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prebiotic (Saccharomyces boulardii) | Active Comparator | 500 mg, 2 times daily for 14 days |
|
| antibiotic (Amoxicillin Clavulanate) | Active Comparator | 875/125 mg 2 times daily at least 1 hour before meals for 7 days |
|
| combination (prebiotic and antibiotic) | Active Comparator | Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily). |
|
| control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saccharomyces boulardii | Dietary Supplement | 500 mg, 2 times daily for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Symptom Rating Scale | Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms | Day 0 |
| Gastrointestinal Symptom Rating Scale | Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms | Day 7 |
| Gastrointestinal Symptoms Response Score | Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms | Day 14 |
| Gastrointestinal Symptoms Response Scale | Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms | Day 21 |
| Prevalence of Escherichia in Stool | Control arm was not assessed as there was no intervention for this group. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21 | Day -7 to Day 21 |
| Operational Taxonomic Units | Core Microbiome includes control samples and baseline samples (Day -7 and Day 0) for antibiotic, probiotic, and combination groups. Data for Core microbiome for individual arms are not available. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21 | Day 0 to Day 21 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30881353 | Derived | Kelly CP, Chong Nguyen C, Palmieri LJ, Pallav K, Dowd SE, Humbert L, Seksik P, Bado A, Coffin B, Rainteau D, Kabbani T, Duboc H. Saccharomyces boulardii CNCM I-745 Modulates the Fecal Bile Acids Metabolism During Antimicrobial Therapy in Healthy Volunteers. Front Microbiol. 2019 Mar 4;10:336. doi: 10.3389/fmicb.2019.00336. eCollection 2019. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Prebiotic (Saccharomyces Boulardii) | Saccharomyces boulardii: 500 mg, 2 times daily for 14 days |
| FG001 | Antibiotic (Amoxicillin Clavulanate) | Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days |
| FG002 | Combination (Prebiotic and Antibiotic) | Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily). |
| FG003 | Control | Control group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Prebiotic (Saccharomyces Boulardii) | Saccharomyces boulardii: 500 mg, 2 times daily for 14 days |
| BG001 | Antibiotic (Amoxicillin Clavulanate) | Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 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 | Gastrointestinal Symptom Rating Scale | Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms | Control participants were not assessed at this time point. | Posted | Mean | Standard Deviation | units on a scale | Day 0 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prebiotic (Saccharomyces Boulardii) | Saccharomyces boulardii: 500 mg, 2 times daily for 14 days |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ciaran Kelly, MD | Beth Israel Deacones Medical Center | 617-667-1272 | ckelly2@bidmc.harvard.edu |
Not provided
| ID | Term |
|---|---|
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Amoxicillin Clavulanate | Drug | 875/125 mg 2 times daily at least 1 hour before meals for 7 days |
|
| BG002 | Combination (Prebiotic and Antibiotic) | Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily). |
| BG003 | Control | control group |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Combination (Prebiotic and Antibiotic) |
Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily). |
|
|
| Primary | Gastrointestinal Symptom Rating Scale | Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms | Posted | Mean | Standard Deviation | Units on a scale | Day 7 |
|
|
|
|
| Primary | Gastrointestinal Symptoms Response Score | Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms | Participants analyzed were those with complete data at Day 14 | Posted | Mean | Standard Deviation | units on a scale | Day 14 |
|
|
|
| Primary | Gastrointestinal Symptoms Response Scale | Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms | Participants analyzed were those with complete data at Day 14 | Posted | Mean | Standard Deviation | units on a scale | Day 21 |
|
|
|
| Primary | Prevalence of Escherichia in Stool | Control arm was not assessed as there was no intervention for this group. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21 | Posted | Mean | Standard Deviation | percentage of total bacteria | Day -7 to Day 21 |
|
|
|
| Primary | Prevalence of Escherichia in Stool | Control arm was not assessed as there was no intervention for this group. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21 | Posted | Mean | Standard Deviation | percentage of total bacteria | Day -7 to Day 21 |
|
|
|
|
| Primary | Prevalence of Escherichia in Stool | Control arm was not assessed as there was no intervention for this group. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21 | Posted | Mean | Standard Deviation | percentage of total bacteria | Day -7 to Day 21 |
|
|
|
| Primary | Operational Taxonomic Units | Core Microbiome includes control samples and baseline samples (Day -7 and Day 0) for antibiotic, probiotic, and combination groups. Data for Core microbiome for individual arms are not available. Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21 | Posted | Mean | Standard Deviation | units | Day 0 to Day 21 |
|
|
|
| 0 |
| 13 |
| 5 |
| 13 |
| EG001 | Antibiotic (Amoxicillin Clavulanate) | Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days | 0 | 12 | 6 | 12 |
| EG002 | Combination (Prebiotic and Antibiotic) | Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily). | 0 | 12 | 2 | 12 |
| EG003 | Control | 0 | 12 | 1 | 12 |
| Abdominal pain | Gastrointestinal disorders |
|
| Abdominal pain upper | Gastrointestinal disorders |
|
| Constipation | Gastrointestinal disorders |
|
| diarrhea | Gastrointestinal disorders |
|
| dyspepsia | Gastrointestinal disorders |
|
| eructation | Gastrointestinal disorders |
|
| flatulence | Gastrointestinal disorders |
|
| gastrointestinal motility disorder | Gastrointestinal disorders |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders |
|
| infrequent bowel movements | Gastrointestinal disorders |
|
| regurgitation | Gastrointestinal disorders |
|
| decreased appetite | Metabolism and nutrition disorders |
|
| vulvovaginal rash | Reproductive system and breast disorders |
|
Not provided
Not provided
Not provided
| D000577 |
| Amides |
| D009930 | Organic Chemicals |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |