N/A N=15

Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis

Ulcerative Colitis

Bottom Line

View on ClinicalTrials.gov: NCT03018925 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2021

Primary outcome: Primary: Golimumab Induced Shifts in the Abundance of Bacterial Markers — 14965109899; 132857054401767; 12779328208; 12851286145 16S gene copies per gram of faeces

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Golimumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Primary completion: Mar 2020

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	—

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

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

View full record on ClinicalTrials.gov →

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.