Status:
UNKNOWN
Fecal Microbiota Transplantation in Ulcerative Colitis
Lead Sponsor:
Assaf-Harofeh Medical Center
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
Fecal Microbiota Transplantation(FMT) - reconstitution of normal flora by a stool transplant from a healthy individual, is increasingly being recognized as a therapeutic modality for diseases that are...
Eligibility Criteria
Inclusion
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women of childbearing potential will have a urine pregnancy test, which must be negative, on Study Day 1, prior to receiving FMT. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for 3 months after FMT.
- Ability to understand and the willingness to sign a written informed consent document, including the willingness to accept risk of unrelated donor stool.
- Ability to swallow oral medications.
Exclusion
- Severe, uncontrolled ulcerative colitis.
- Patients with active or uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
- Delayed gastric emptying syndrome
- Known chronic aspiration
- Patients with a history of significant allergy to foods not excluded from the donor diet (excluded foods are tree nuts, peanuts, shellfish, eggs)
- Pregnant and breast-feeding women
- Participants who are unable to swallow pills.
Key Trial Info
Start Date :
March 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03273465
Start Date
March 27 2017
End Date
April 1 2021
Last Update
September 6 2017
Active Locations (1)
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1
Assaf-HarofehMC
Ẕerifin, Israel, 70300