Trial · NCT04979832
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1: safety study, Determine serious adverse reactions or adverse reactions from the application of GM-CSF, metronidazole and fosfomycin in the pouch | 30 days after first application of study drug | Incidence of Treatment-Emergent Adverse Events |
| Primary | Phase 2: Proof of concept study, Change in the pouchitis disease activity index (PDAI) | 14 days after first application of the study drug | A decrease of 3 points or more will be determined as an improvement in PDAI from before application of the study drug to 7 days after application of the study drug. Between 0-18 points can be given, with a score of 7 or higher indicating pouchitis. |
| Secondary | Phase 1: Change in the pouchitis disease activity index (PDAI) | Within 7 days after application of the study drug | A decrease of 3 points or more will be determined as an improvement in PDAI from before application of the study drug to 7 days after application of the study drug. Between 0-18 points can be given, with a score of 7 or higher indicating pouchitis. |
| Secondary | Phase 1: Number of trial participants with a change in median white blood cells after treatment | Within 7 days after application of the study drug | Change in median white blood cells (numbers × 10\^9/L) |
| Secondary | Phase 1: Number of trial participants with a change in median CRP after treatment | Within 7 days after application of the study drug | Change in median CRP (mg/L) |
| Secondary | Phase 1: Number of trial participants with a change in median creatinine after treatment | Within 7 days after application of the study drug | Change in median creatinine (µmol/L) |
| Secondary | Phase 1: Number of trial participants with a change in median liver enzymes after treatment | Within 7 days after application of the study drug | Change in median liver enzymes (ALAT, alanine-aminotransferase in U/L) |
| Secondary | Phase 1: Change in microbial diversity in the pouch using 16S rRNA sequencing | Within 7 days after application of the study drug | A qualitative assessment of the microbial diversity of the mucosa of the pouch by determining species names and distribution quantity using 16S rRNA sequencing. |
| Secondary | Phase 2: Change in the clinical, endoscopic or histological PDAI | 14 days after first application of the study drug | A decrease of 3 points or more will be determined as an improvement in PDAI individually for clinical (0-6 points), endoscopic (0-6 points) and histological (0-6 points) PDAI. |
| Secondary | Phase 2: Number of trial participants with a change in median white blood cells after treatment | 14 days after first application of the study drug | Change in median white blood cells (numbers × 10\^9/L) |
| Secondary | Phase 2: Number of trial participants with a change in median CRP after treatment | 14 days after first application of the study drug | Change in median CRP (mg/L) |
| Secondary | Phase 2: Number of trial participants with a change in median creatinine after treatment | 14 days after first application of the study drug | Change in median creatinine (µmol/L) |
| Secondary | Phase 2: Number of trial participants with a change in median liver enzymes after treatment | 14 days after first application of the study drug | Change in median liver enzymes (ALAT, alanine-aminotransferase in U/L) |
| Secondary | Phase 2: Change in microbial diversity in the pouch using 16S rRNA sequencing | 14 days after first application of the study drug | A qualitative assessment of the microbial diversity of the mucosa of the pouch by determining species names and distribution quantity using 16S rRNA sequencing. |
| Secondary | Phase 2: Determine serious adverse reactions or adverse reactions from the application of GM-CSF, metronidazole and fosfomycin in the pouch | 37 days after first application of the study drug | Incidence of Treatment-Emergent Adverse Events |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT04979832/registered