Trial · NCT05702879
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Development of a predictive score regarding success of anti-inflammatory therapy after start of a new treatment in ulcerative colitis | 4 months | The predictive microbiota signature will be developed using machine learning, considering clinical data, microbiota descriptors, and metabolic changes from day 0 to week 4 (see analysis). Clinical response will be defined as a decrease in the simple clinical colitis activity index (SCCAI) score by ≥3 points 25or to a level of ≤2.5 points 26 at 8 weeks after the start of anti-inflammatory treatment. |
| Secondary | Predicting clinical remission | 8 weeks | Assessment of the microbiota/metabolic signature predicting clinical remission (SSCAI \<2.5) |
| Secondary | Predicting clinical remission | 12 weeks | Assessment of the microbiota/metabolic signature predicting clinical remission (SSCAI \<2.5) |
| Secondary | Predicting clinical remission | 6 months | Assessment of the microbiota/metabolic signature predicting clinical remission (SSCAI \<2.5) |
| Secondary | Predicting clinical remission | 12 months | Assessment of the microbiota/metabolic signature predicting clinical remission (SSCAI \<2.5) |
| Secondary | Predicting calprotectin reduction | 2 weeks | Assessment of the microbiota/metabolic signature predicting a reduction in fecal calprotectin levels |
| Secondary | Predicting calprotectin reduction | 8 weeks | Assessment of the microbiota/metabolic signature predicting a reduction in fecal calprotectin levels |
| Secondary | Predicting calprotectin reduction | 12 weeks | Assessment of the microbiota/metabolic signature predicting a reduction in fecal calprotectin levels |
| Secondary | Predicting calprotectin reduction | 6 months | Assessment of the microbiota/metabolic signature predicting a reduction in fecal calprotectin levels |
| Secondary | Predicting calprotectin reduction | 12 months | Assessment of the microbiota/metabolic signature predicting a reduction in fecal calprotectin levels |
| Secondary | Differential microbiota response to therapy: Ozanimod | 12 months | Sensitivity analysis in the subgroup treated with Ozanimod in regards to differential signatures in the prediction signature |
| Secondary | Differential microbiota response to therapy: TNF-inhibitors | 12 months | Sensitivity analysis in the subgroup treated with TNF-inhibitors in regards to differential signatures in the prediction signature |
| Secondary | Differential microbiota response to therapy: Vedolizumab | 12 months | Sensitivity analysis in the subgroup treated with Vedolizumab in regards to differential signatures in the prediction signature |
| Secondary | Differential microbiota response to therapy: Ustekinumab | 12 months | Sensitivity analysis in the subgroup treated with Ustekinumab in regards to differential signatures in the prediction signature |
| Secondary | Differential microbiota response to therapy: Steroids | 12 months | Sensitivity analysis in the subgroup treated with Steroids in regards to differential signatures in the prediction signature |
| Secondary | Signature differences between ulcerative colitis and healthy controls | 12 months | Comparison of microbiota/metabolic signatures between ulcerative colitis patients and controls using clustering and differential abundance analysis |
| Secondary | Metagenomic substrain assessment | 12 months | Identification of substrains in patient samples using metagenomic sequencing and follow up their persistence/loss over time |
| Secondary | Fatigue assessment | 12 months | Fatigue severity measured by the fatigue severity scale over time and assessed for reduction after therapy start |
| Secondary | Adverse effects | 12 months | Assessment regarding potential adverse effects in relation medical therapy by screening questionnaires |
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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