Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis

Sponsor
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Study ID
NCT03018925
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — DRUG
    The treatment followed was an induction of 200 mg of Golimumab at week 0, and 100 mg at week 2. Under 70 Kg, the follow-up treatment dose would be 50 mg/month, and 100 mg/month in patients above 70 Kg asindicated in standard clinical practice.

Study Details

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

Key Dates

Start date
Oct 31, 2016
Status verified
Jun 2021
Primary completion
Mar 31, 2020
Completion
Oct 31, 2020

Study Design

Enrollment
15 participants (actual)

Arms

  • Arm: Ulcerative Colitis
    The proposed study will include 15 UC anti-TNF naïve patients . We will consider remission when patients have an endoscopic Mayo score ≤1, and activity index score, Mayo= 0 points. Stool samples will be collected before starting Anti-TNF treatment (M0), and then every 3 months (M1, M2, M3 and M4) to complete the study. GOLIMUMAB induction with 200mg at week 0, and 100mg at week 2. Under 70kg, the follow up treatment will be 50mg/month, and 100mg/month in patients over 70kg, as clinical practice.

Primary Outcome Measure

Golimumab Induced Shifts in the Abundance of Bacterial Markers [ Time Frame: Baseline (week 0); week 4; week 9; week 13; week 26; week 39; week 52 ]

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