Trial · NCT04979832
GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery
NCT04979832, Phase 1, Phase 2, Unknown, Zealand University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery. Trials, record NCT04979832. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04979832
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GM-CSF, Fosfomycin and Metronidazole for Pouchitis in Ulcerative Colitis Patients After Restorative IPAA Surgery
- NCT number
- NCT04979832
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 18 participants, estimated
- Lead sponsor
- Zealand University Hospital
- Conditions
- Pouchitis
- Interventions
- GM-CSF, fosfomycin and metronidazole
- First posted
- 2021-07-28
- Last updated
- 2023-01-26
- Other registries' IDs
- eudract:2020-000609-10
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42728546 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04979832
GET https://conductscience.org/api/trials/v1/NCT04979832/registered