N/A
Completed N=15
Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis
Source: ClinicalTrials.gov NCT03018925 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Golimumab Induced Shifts in the Abundance of Bacterial Markers — 14965109899; 132857054401767; 12779328208; 12851286145 16S gene copies per gram of faeces
Summary
This study aims to characterize the changes on intestinal microbiota pattern associated with the use of golimumab in order to determine if intestinal microbiota markers may correlate with golimumab therapeutic effect in patients naïve & non-naïve to anti-TNF treatment
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Golimumab Induced Shifts in the Abundance of Bacterial Markers |
14965109899; 132857054401767; 12779328208; 12851286145; 12454690659; 12503490379 | — |
| SECONDARY Golimumab Induced Shifts in Calprotectin Faecal Sample Levels |
1379.78; 626.79; 1267.50; 1036.68; 994.39; 545.64 | — |
| SECONDARY Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score |
2; 0; 9; 5; 2; 0 | — |
Eligibility Criteria
Inclusion Criteria
- > 18 years
- Signed the informed consent
- Anti-TNF naïve
- Screening for opportunistic infections
Exclusion Criteria
- Active tuberculosis or another chronic infections
- Antibiotic treatment prior 1 month
- Probiotics & Prebiotics
- Gestation and lactation
- Heart disfunction
- Colectomy
Data sourced from ClinicalTrials.gov (NCT03018925). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.