Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis

NCT03018925 | Completed Results

• 1 other identifier: IISP 53713
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Golimumab Induced Shifts in the Abundance of Bacterial Markers

  Shifts of abundance of Eubacteria (EUB), A. municiphila (AKK), M. smithii (MSM), Bacteroidetes (BAC), Ruminococcus sp. (RUM), F. prausnitzii (FPRA) and E. coli (ECO) levels will be measured prior (week 0) and progressively all through golimumab therapy until week 54. Results will be expressed as 16S gene copies of microbes per gram of faeces.

  Baseline (week 0); week 4; week 9; week 13; week 26; week 39; week 52

Secondary Outcomes (2)

• Golimumab Induced Shifts in Calprotectin Faecal Sample Levels

  Baseline (week 0); week 4; week 9; week 13; week 26; week 39; week 52

• Golimumab Induced Shifts in Clinical Response Based on Partial Mayo Score

  Baseline (week 0) and week 52

Study Arms (1)

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.

Drug: Golimumab

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.

Ulcerative Colitis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The proposed study will include 15 UC patients over 18 years, that have signed the informed consent, subjected to treatment with anti-TNF by clinical practice and who have made screening for opportunistic infections. Patients will be anti-TNF naïve patients.

You may qualify if:

• \> 18 years
• Signed the informed consent
• Anti-TNF naïve
• Screening for opportunistic infections

You may not qualify if:

• Active tuberculosis or another chronic infections
• Antibiotic treatment prior 1 month
• Probiotics \& Prebiotics
• Gestation and lactation
• Heart disfunction
• Colectomy

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: lead

Study Sites (1)

Hospital Doctor Josep Trueta

Girona, Catalonia, 17007, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

STOOL SAMPLE

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

golimumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: MD PhD X Aldeguer
• Organization: Institut d'Investigació Biomèdica de Girona - Hosp Univ Dr Josep Trueta

xaldeguer.girona.ics@gencat.cat; abahi@idibgi.org

34972940200

Study Officials

• Xavier XA Aldeguer, Dr.

  Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterology Department

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: January 12, 2017
• Study Start: October 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: October 1, 2020
• Last Updated: July 19, 2021
• Results First Posted: July 19, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)