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IRCT20210113050024N1 IRCT 2021-02-08 Esfahan University of Medical Sciences Fecal Microbiota Transplantation in Patients with Ulcerative Colitis Feasibility Study of Fecal Microbiota Transplantation (FMT) in Patients with Ulcerative Colitis 2021-04-08 anticipated 5 Complete https://irct.ir/trial/53668 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: This is phase 2 clinical trial which has one group receiving intervention. 2 Ulcerative colitis. Intervention group: 5 patients with ulcerative colitis and 5 healthy donors according to inclusion and exclusion criteria using non-probable method will enter into the study. The fresh stool samples were obtained from the healthy donors following the standard protocol. 300cc diluted-filtered stool extracted from 50gr solid stool from healthy donors will be injected into the patients' large intestine through colonoscopy, every 2 weeks during 2 months. There is no control group.. Yes - There is a plan to make this available What will be shared: The informed consent will be available The data set will be available The statistical data analysis will be available When: The informed consent will be shared at the end of the study The data set will be shared after publication The statistical data analysis will be shared after publication To whom: The data will be available for the researchers in scientific and educational centers around the world Conditions: Use of the data for second analysis will be possible in condition of execute satisfaction Where to obtain: Dr. Nazila Kassaian , Dr. Babak Tamizifar Gastrointestinal and hepatology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran 009831-38222675 ighrc@mui.ac.ir How to obtain: It is sufficient to contact with the executes for data request. The data will be submitted during one week in condition of agreement. Comments:
public Nazila Kassaian
Isfahan University of Medical Sciences, Hezarjerib st.
Isfahan Iran (Islamic Republic of) 81745319 +98 31 3237 4705 nkassaian@gmail.com Esfahan University of Medical Sciences scientific Babak Tamizifar
Isfahan University of Medical Sciences, Hezarjerib st, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 81745319 +98 31 3792 3060 babaktt@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) For the patients: the volunteers aged 18-65 years with Ulcerative Colitis who have been diagnosed by 3 months and are in moderate-severe phase For the stool donor: the healthy volunteers aged 18-65 years 18 years 65 years Both For the stool donor: Having signs or existence of gastro- enteric diseases existence of other diseases like diabetes, cardiovascular, liver, and kidney diseases Using antibiotic/ anti fungal/ anti viral or probiotics Using immunosuppressive and anti carcinogenic drugs affected by autoimmune and atopic diseases With metabolic syndrome, obesity(BMI>30) or under nutrition(BMI<18) chronic pain syndrome, psychological diseases, and carcinoma Infectious disease like hepatitis B, hepatitis C, AIDS, and respiratory infections Close contact to somebody who have had viral hepatitis or AIDS during the last year high risk behaviors like sigh risky sex, tattooing, or piercing in the last 6 months consumption illegal drugs and opium going to diarrheic endemic zone during the last 6 months the history of inflammation bowel diseases, chronic diarrhea and the other GI diseases the history of GI cancer or Polyposis the history of colorectal cancer in the first degree relatives the history of GI surgery like bypass infected by corona virus K51 Ulcerative colitis Treatment - Other Intervention group: 5 patients with ulcerative colitis and 5 healthy donors according to inclusion and exclusion criteria using non-probable method will enter into the study. The fresh stool samples were obtained from the healthy donors following the standard protocol. 300cc diluted-filtered stool extracted from 50gr solid stool from healthy donors will be injected into the patients' large intestine through colonoscopy, every 2 weeks during 2 months. There is no control group. The clinical score based on Lightiger test. Timepoint: at the first(mo 0), after intervention period(mo 2), at the end(mo 4). Method of measurement: using Lightiger questionnaire. Quantity of intestinal targeted bacteria. Timepoint: at the first(mo 0), and at the end(mo 4) of study. Method of measurement: Q-PCR. Esfahan University of Medical Sciences Approved 2021-01-06 The ethical committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Research Chancelor, Hezarjerib st., Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)