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Feasibility Study of Fecal Microbiota Transplantation (FMT) in Patients with Ulcerative Colitis

Protocol summary

Study aim
The assessment and comparison of clinical feature score and the stool targeted microbiome count due to fecal microbiota transplantation in patients with ulcerative colitis
Design
In a feasibility study of phase 1-2 clinical trial, 5 patients with ulcerative colitis and 5 healthy stool donors based on inclusion and exclusion criteria in non-probable method were enrolled.
Settings and conduct
The reception and preparation of the fresh stool for injection from healthy donors will be done based on the standard protocols. The solution will be injected to patients' large intestine via colonoscopy every 2 weeks for 2 months in gastrointestinal health center, Isfahan university of medical sciences. The clinical feature for the patients will be assessed at the beginning, after 2 months and after 4 months by LIGHTIGER score test. In addition, the count of targeted gut microbiota using quantitate-real time-PCR will be evaluated before the study and after 4 months for the patients and before the study for healthy donors.
Participants/Inclusion and exclusion criteria
For the patients: patients 18-65 years with at list 3 months diagnosis of ulcerative colitis For the stool donors: The healthy volunteer 18-65 years subjects without any condition or sign of gastrointestinal diseases or infections, diabetes, cardiovascular diseases, and also hepatic, kidney, and psychological disease, not use of anti biotic, anti fungal, anti viral, or probiotics during past 3 months
Intervention groups
300 cc refined stool obtained from 50 gr stool of healthy donor will be injected to the colon of 5 patients with ulcerative colitis by colonoscopy each 2 weeks for 2 months. There is not any control group.
Main outcome variables
Clinical symptom score; quantity of targeted Gut microbiota

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210113050024N1
Registration date: 2021-02-08, 1399/11/20
Registration timing: prospective

Last update: 2021-02-08, 1399/11/20
Update count: 0
Registration date
2021-02-08, 1399/11/20
Registrant information
Name
Nazila Kassaian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3237 4705
Email address
nkassaian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-08, 1400/01/19
Expected recruitment end date
2021-08-05, 1400/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Feasibility Study of Fecal Microbiota Transplantation (FMT) in Patients with Ulcerative Colitis
Public title
Fecal Microbiota Transplantation in Patients with Ulcerative Colitis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
This is phase 2 clinical trial which has one group receiving intervention

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethical committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Research Chancelor, Hezarjerib st., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81745319
Approval date
2021-01-06, 1399/10/17
Ethics committee reference number
IR.MUI.MED.REC.1399.899

Health conditions studied

1

Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

Primary outcomes

1

Description
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

2

Description
quantity of intestinal targeted bacteria
Timepoint
at the first(mo 0), and at the end(mo 4) of study
Method of measurement
Q-PCR

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
gastroenterology and hepatology research center, Isfahan University of Medical Sciences, Isfahan, I
Full name of responsible person
Nazila Kassaian
Street address
Isfahan University of Medical Sciences, Hezarjerib st.
City
Isfahan
Province
Isfehan
Postal code
81745319
Phone
+98 31 3237 4705
Email
nkassaian@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezarjerib st.
City
Isfahan
Province
Isfehan
Postal code
81745319
Phone
+98 31 3792 3060
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nazila Kassaian
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezarjerib st.
City
Isfahan
Province
Isfehan
Postal code
81745319
Phone
+98 31 3237 4705
Email
nkassaian@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Babak Tamizifar
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Isfahan University of Medical Sciences, Hezarjerib st, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81745319
Phone
+98 31 3792 3060
Email
babaktt@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nazila Kassaian
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Isfahan University of Medical Sciences, Hezarjerib st., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81745319
Phone
+98 31 3237 4705
Fax
Email
nkassaian@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The informed consent will be available The data set will be available The statistical data analysis will be available
When the data will become available and for how long
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 data/document is available
The data will be available for the researchers in scientific and educational centers around the world
Under which criteria data/document could be used
Use of the data for second analysis will be possible in condition of execute satisfaction
From where data/document is obtainable
Dr. Nazila Kassaian , Dr. Babak Tamizifar Gastrointestinal and hepatology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran 009831-38222675 ighrc@mui.ac.ir
What processes are involved for a request to access data/document
It is sufficient to contact with the executes for data request. The data will be submitted during one week in condition of agreement.
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