ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT03018925
Date of registration:	13/12/2016
Prospective Registration:	No
Primary sponsor:	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Public title:	Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis GOLI2015
Scientific title:	Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis: Pilot Study
Date of first enrolment:	October 2016
Target sample size:	15
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03018925
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Spain

Contacts

Name:	Xavier Aldeguer, MD PhD
Address:
Telephone:	+34972940287
Email:	xaldeguer@idibgi.org
Affiliation:

Name:	Xavier XA Aldeguer, Dr.
Address:
Telephone:
Email:
Affiliation:	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Name:	Xavier XA Aldeguer, Dr.
Address:
Telephone:	972940287
Email:	xaldeguer@idibgi.org
Affiliation:

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis

Intervention(s)

Drug: Golimumab

Primary Outcome(s)

Change from baseline in dysbiosis fecal markers based on the levels of Fecalibacterium prausnitzii phylotypes and E coli loads [Time Frame: Baseline ( week 0); week 4; week 8; week 12; week 16; week 20; week 24; week 28]

Secondary Outcome(s)

Change from baseline in Calprotectin fecal sample levels [Time Frame: Baseline ( week 0); week 4; week 8; week 12; week 16; week 20; week 24; week 28]

Change in clinical response based on Mayo Clinic Index [Time Frame: Baseline ( week 0); week 4; week 8; week 12; week 16; week 20; week 24; week 28]

Secondary ID(s)

IISP 53713

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.