A Phase 2 interventional study of Fluconazole and Vancomycin in Crohn's Disease, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment
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.
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 8 is below the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Vancomycin · Drug: Neomycin · Drug: Ciprofloxacin · Drug: Polyethylene Glycol 3350 · Drug: Promethazine
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 · Drug: Neomycin · Drug: Ciprofloxacin · Drug: Polyethylene Glycol 3350 · Drug: Promethazine · Drug: Fluconazole placebo
400mg orally once daily (Day 1-14)
Also known as: Diflucan
500mg oral suspension 4 times daily (Day 1-14)
Also known as: Vancocin
neomycin 1000 mg orally three times daily (Days 1-3)
Also known as: Neo-Fradin
ciprofloxacin 750 mg orally twice daily (Day 4-14)
Also known as: Cipro
238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2
Also known as: Miralax
PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).
Also known as: Phenergan
Once daily
Change in Disease Activity by Harvey Bradshaw Index
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
Change in Disease Activity by Fecal Calprotectin (FCP)
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
The Change in High-sensitivity C-reactive Protein (hsCRP)
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
Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs).
Number of Medication Side Effects and/or Adverse Events (AEs)
Time frame: 105 days
| Milestone | Fluconazole | Placebo |
|---|---|---|
| Started | 4 | 4 |
| Completed | 4 | 4 |
| Not completed | 0 | 0 |
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
| score on a scale | Fluconazole | Placebo |
|---|---|---|
| Change in Disease Activity by Harvey Bradshaw Index | -5 (-7 to 0) | -3 (-8 to -2) |
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.
| mcg/g | Fluconazole | Placebo |
|---|---|---|
| Change in Disease Activity by Fecal Calprotectin (FCP) | -16.5 (-116.48 to 94) | -380.5 (-1234 to -1) |
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.
| mg/dL | Fluconazole | Placebo |
|---|---|---|
| The Change in High-sensitivity C-reactive Protein (hsCRP) | 4.1 (1.1 to 8.3) | -2 (-2.9 to 1.6) |
Number of Medication Side Effects and/or Adverse Events (AEs)
| Events | Fluconazole | Placebo |
|---|---|---|
| Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs). | 31 | 12 |
Collected over 105 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluconazole | 0/4 (0%) | 0/4 (0%) | 4/4 (100%) |
| Placebo | 0/4 (0%) | 0/4 (0%) | 3/4 (75%) |
| Event | Fluconazole | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 4/4 | 2/4 |
| Increased abdominal painGastrointestinal disorders | 3/4 | 0/4 |
| Increased diarrheaGastrointestinal disorders | 3/4 | 3/4 |
| VomitingGastrointestinal disorders | 1/4 | 0/4 |
| Back painMusculoskeletal and connective tissue disorders | 1/4 | 0/4 |
| ConstipationGastrointestinal disorders | 0/4 | 1/4 |
| Perianal irritationGastrointestinal disorders | 0/4 | 1/4 |
| FlushingSkin and subcutaneous tissue disorders | 1/4 | 0/4 |
| Decreased appetiteGastrointestinal disorders | 1/4 | 0/4 |
| Eye irritationEye disorders | 0/4 | 1/4 |
| Age, Continuous(years) | Fluconazole | Placebo | Total |
|---|---|---|---|
| Median | 44 (26 to 54) | 32.5 (20 to 66) | 39.5 (20 to 66) |
| Sex: Female, Male(Participants) | Fluconazole | Placebo | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 3 | 4 | 7 |
| Race and Ethnicity Not Collected(Participants) | Fluconazole | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Fluconazole | Placebo | Total |
|---|---|---|---|
| United States | 4 | 4 | 8 |
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University of Pennsylvania