Fecal Microbiota Transplantation in Patients with Ulcerative Colitis

Phase 2

• Conditions: lcerative colitis.; Ulcerative colitis

• Registration Number: IRCT20210113050024N1
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.