Holiday: Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
Study Details
Study Description
Brief Summary
To determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) that is refractory to conventional, immunosuppressive therapy.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Fluconazole Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). |
Drug: Fluconazole
400mg orally once daily (Day 1-14)
Other Names:
Drug: Vancomycin
500mg oral suspension 4 times daily (Day 1-14)
Other Names:
Drug: Neomycin
neomycin 1000 mg orally three times daily (Days 1-3)
Other Names:
Drug: Ciprofloxacin
ciprofloxacin 750 mg orally twice daily (Day 4-14)
Other Names:
Drug: Polyethylene Glycol 3350
238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2
Other Names:
Drug: Promethazine
PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).
Other Names:
|
Placebo Comparator: Placebo Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). |
Drug: Vancomycin
500mg oral suspension 4 times daily (Day 1-14)
Other Names:
Drug: Neomycin
neomycin 1000 mg orally three times daily (Days 1-3)
Other Names:
Drug: Ciprofloxacin
ciprofloxacin 750 mg orally twice daily (Day 4-14)
Other Names:
Drug: Polyethylene Glycol 3350
238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2
Other Names:
Drug: Promethazine
PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).
Other Names:
Drug: Fluconazole placebo
Once daily
|
Outcome Measures
Primary Outcome Measures
- Change in Disease Activity by Harvey Bradshaw Index [enrollment visit (baseline) and 15 days]
The primary endpoint will be the change in disease activity, as measured by Harvey-Bradshaw Index (HBI) score, between the enrollment visit and Day 15. All participants who withdraw for any reason prior to day 15 will be considered treatment failures. The HBI is a clinical score where points are given for each category below plus number of liquid bowel movements in previous day. A score of 3 or lower is considered remission. A score of 8 or higher is considered severe disease. General Well Being Very well 0 points Slightly below par 1 point Poor 2 points Very poor 3 points Terrible 4 points Abdominal Pain None 0 points Mild 1 point Moderate 2 points Severe 3 points Abdominal Mass None 0 points Dubious 1 point Definite 2 points Definite and tender 3 points Complications None 0 points Arthralgias +1 point Uveitis +1 point Erythema Nodosum + 1 point Aphthous ulcers +1 point Pyoderma Gangrenosum + 1 point Anal fissure + 1 point New fistula + 1
- Change in Disease Activity by Fecal Calprotectin (FCP) [enrollment visit (baseline) and 15 days]
The second primary outcome measure will be the change in disease activity, as measured by fecal calprotectin, between the enrollment visit and day 15. The fecal calprotectin is a stool test which measures intestinal inflammation.
Secondary Outcome Measures
- The Change in High-sensitivity C-reactive Protein (hsCRP) [enrollment visit (baseline) and 15 days]
A secondary outcome measure will be the change in high-sensitivity C-reactive protein between the enrollment visit and day 15. The high-sensitivity C-reactive protein is a blood test which measures systemic inflammation.
- Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs). [105 days]
Number of Medication Side Effects and/or Adverse Events (AEs)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant is capable of giving informed consent
-
Males or females 18-75 years of age
-
Normal kidney function (defined by normal serum creatinine [male: <1.27 mg/dL; female: <1.03 mg/dL])
-
Normal aspartate aminotransferase [AST] (<41 U/L), alanine aminotransferase [ALT] (<63 U/L), and alkaline phosphatase (<126 U/L)
-
Active CD defined as HBI ≥ 7
-
CRP > 5 mg/dL or hs-CRP > 10mg/L (or 1mg/dL) or fecal calprotectin (FCP) > - - 350 mcg/g (within one month of enrollment)
-
Have been treated with one of the following therapies** for at least 8 weeks with primary nonresponse or an initial response, followed by loss of response [LOR] (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine, methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab, vedolizumab, or ustekinumab **These medications must have been administered at standard, therapeutic dosages.
Exclusion Criteria:
-
Known or suspected stricturing disease producing obstructive symptoms
-
Active Clostridium difficile infection
-
Unwillingness to provide informed consent
-
Allergy or intolerance to the medications used in this study
-
History of kidney disease
-
History of liver disease
-
Pregnant or lactating females
-
Baseline QTc interval on EKG > 430 in males or > 450 in females
-
Participants who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- University of Pennsylvania
- Children's Hospital of Philadelphia
- Crohn's and Colitis Foundation
Investigators
- Principal Investigator: Lindsey Albenberg, DO, University of Pennsylvania
- Principal Investigator: James D Lewis, MD, MSCE, University of Pennsylvania
Study Documents (Full-Text)
More Information
Publications
None provided.- 823635
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Fluconazole | Placebo |
---|---|---|
Arm/Group Description | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole: 400mg orally once daily (Day 1-14) Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole placebo: Once daily |
Period Title: Overall Study | ||
STARTED | 4 | 4 |
COMPLETED | 4 | 4 |
NOT COMPLETED | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Fluconazole | Placebo | Total |
---|---|---|---|
Arm/Group Description | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole: 400mg orally once daily (Day 1-14) Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole placebo: Once daily | Total of all reporting groups |
Overall Participants | 4 | 4 | 8 |
Age (years) [Median (Full Range) ] | |||
Median (Full Range) [years] |
44
|
32.5
|
39.5
|
Sex: Female, Male (Count of Participants) | |||
Female |
1
25%
|
0
0%
|
1
12.5%
|
Male |
3
75%
|
4
100%
|
7
87.5%
|
Race and Ethnicity Not Collected (Count of Participants) | |||
Count of Participants [Participants] |
0
0%
|
||
Region of Enrollment (participants) [Number] | |||
United States |
4
100%
|
4
100%
|
8
100%
|
Outcome Measures
Title | Change in Disease Activity by Harvey Bradshaw Index |
---|---|
Description | The primary endpoint will be the change in disease activity, as measured by Harvey-Bradshaw Index (HBI) score, between the enrollment visit and Day 15. All participants who withdraw for any reason prior to day 15 will be considered treatment failures. The HBI is a clinical score where points are given for each category below plus number of liquid bowel movements in previous day. A score of 3 or lower is considered remission. A score of 8 or higher is considered severe disease. General Well Being Very well 0 points Slightly below par 1 point Poor 2 points Very poor 3 points Terrible 4 points Abdominal Pain None 0 points Mild 1 point Moderate 2 points Severe 3 points Abdominal Mass None 0 points Dubious 1 point Definite 2 points Definite and tender 3 points Complications None 0 points Arthralgias +1 point Uveitis +1 point Erythema Nodosum + 1 point Aphthous ulcers +1 point Pyoderma Gangrenosum + 1 point Anal fissure + 1 point New fistula + 1 |
Time Frame | enrollment visit (baseline) and 15 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Fluconazole | Placebo |
---|---|---|
Arm/Group Description | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole: 400mg orally once daily (Day 1-14) Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole placebo: Once daily |
Measure Participants | 4 | 4 |
Median (Full Range) [score on a scale] |
-5
|
-3
|
Title | Change in Disease Activity by Fecal Calprotectin (FCP) |
---|---|
Description | The second primary outcome measure will be the change in disease activity, as measured by fecal calprotectin, between the enrollment visit and day 15. The fecal calprotectin is a stool test which measures intestinal inflammation. |
Time Frame | enrollment visit (baseline) and 15 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Fluconazole | Placebo |
---|---|---|
Arm/Group Description | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole: 400mg orally once daily (Day 1-14) Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole placebo: Once daily |
Measure Participants | 4 | 4 |
Median (Full Range) [mcg/g] |
-16.5
|
-380.5
|
Title | The Change in High-sensitivity C-reactive Protein (hsCRP) |
---|---|
Description | A secondary outcome measure will be the change in high-sensitivity C-reactive protein between the enrollment visit and day 15. The high-sensitivity C-reactive protein is a blood test which measures systemic inflammation. |
Time Frame | enrollment visit (baseline) and 15 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Fluconazole | Placebo |
---|---|---|
Arm/Group Description | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole: 400mg orally once daily (Day 1-14) Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole placebo: Once daily |
Measure Participants | 4 | 4 |
Median (Full Range) [mg/dL] |
4.1
|
-2
|
Title | Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs). |
---|---|
Description | Number of Medication Side Effects and/or Adverse Events (AEs) |
Time Frame | 105 days |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Fluconazole | Placebo |
---|---|---|
Arm/Group Description | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole: 400mg orally once daily (Day 1-14) Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole placebo: Once daily |
Measure Participants | 4 | 4 |
Number [Events] |
31
|
12
|
Adverse Events
Time Frame | 105 days | |||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Fluconazole | Placebo | ||
Arm/Group Description | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole: 400mg orally once daily (Day 1-14) Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole placebo: Once daily | ||
All Cause Mortality |
||||
Fluconazole | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/4 (0%) | 0/4 (0%) | ||
Serious Adverse Events |
||||
Fluconazole | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/4 (0%) | 0/4 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Fluconazole | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 4/4 (100%) | 3/4 (75%) | ||
Eye disorders | ||||
Eye irritation | 0/4 (0%) | 0 | 1/4 (25%) | 1 |
Gastrointestinal disorders | ||||
Nausea | 4/4 (100%) | 4 | 2/4 (50%) | 2 |
Vomiting | 1/4 (25%) | 1 | 0/4 (0%) | 0 |
Increased abdominal pain | 3/4 (75%) | 3 | 0/4 (0%) | 0 |
Increased diarrhea | 3/4 (75%) | 3 | 3/4 (75%) | 3 |
Constipation | 0/4 (0%) | 0 | 1/4 (25%) | 1 |
Perianal irritation | 0/4 (0%) | 0 | 1/4 (25%) | 1 |
Decreased appetite | 1/4 (25%) | 1 | 0/4 (0%) | 0 |
Defecation urgency | 0/4 (0%) | 0 | 1/4 (25%) | 1 |
Musculoskeletal and connective tissue disorders | ||||
Back pain | 1/4 (25%) | 1 | 0/4 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||
Flushing | 1/4 (25%) | 1 | 0/4 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Lindsey Albenberg, DO |
---|---|
Organization | University of Pennsylvania |
Phone | 267-426-0139 |
albenbergl@email.chop.edu |
- 823635