Fecal Microbiota Transplantation in Patients With Ulcerative Colitis
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|ClinicalTrials.gov Identifier: NCT01961492|
Recruitment Status : Recruiting
First Posted : October 11, 2013
Last Update Posted : December 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Other: Fecal microbiota transplantation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Fecal Microbiota Transplantation Via Colonoscope as an Adjunct Therapy in the Treatment of Ulcerative Colitis|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Fecal microbiota transplantation
A single fecal microbiota transplantation via colonoscope as an adjunct therapy to standard medical treatment
Other: Fecal microbiota transplantation
A single fecal microbiota transplantation through colonoscope
No Intervention: Standard medical treatment
Standard medical treatment as recommended by the ECCO Guidelines of UC therapy.
- Activity of ulcerative colitis [ Time Frame: Within 1 year after the intervention ]Change from baseline in the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 1 month, 3 months, 6 months, and 12 months.
- Colonic inflammation [ Time Frame: Within 1 year after the intervention ]Change from baseline in the fecal calprotectin at 1 month, 3 months, 6 months, and 12 months.
- Colonic inflammation [ Time Frame: Within 1 year after the intervention ]Endoscopic Mayo score at 3 and 12 months after the intervention
- Adverse events [ Time Frame: Within 1 year after the intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961492
|Contact: Marko Kalliomäki, MDemail@example.com|
|Turku University Hospital||Recruiting|
|Turku, Finland, 20520|
|Principal Investigator: Marko Kalliomäki, MD|
|Principal Investigator:||Marko Kalliomäki, MD||Turku University Hospital|