Viewing Study NCT04687150


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Study NCT ID: NCT04687150
Status: UNKNOWN
Last Update Posted: 2022-10-19
First Post: 2020-11-30
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Fecal Microbiota Transplantation and Newly Diagnosed Ulcerative Colitis (UC)
Sponsor: Turku University Hospital
Organization:

Study Overview

Official Title: Fecal Microbiota Transplantation in Newly Diagnosed Ulcerative Colitis Patients
Status: UNKNOWN
Status Verified Date: 2022-10
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: FinUC
Brief Summary: In this FinUC study we are trying to find out the efficacy and safety of the Fecal microbiota transplantation (FMT) in newly diagnosed active ulcerative colitis patients. The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse“s visit. The control group will be given colored water. The main aim of the FinUC study is to determine how the FMT change of the gut microbiota composition in newly diagnosed active ulcerative colitis patients. The other aim is to determine efficacy and mechanisms of fecal microbiota transplantation.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: