Fecal Microbiota Transplantation in Ulcerative Colitis
Fecal Microbiota Transplantation in Ulcerative Colitis
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 associated with gut dysbiosis.

 This is a placebo-controlled, double blinded interventional study evaluating multiple, oral,
 fecal microbiota transplantation, administered in newly diagnosed adult patients with
 mild-moderate UC.

 The primary objective is to assess the safety and feasibility of multiple, oral, fecal
 microbiota transplantation,in newly diagnosed adult patients with mild-moderate UC.

 All processing will occur at the Center for Microbiome Research at Assaf Harofeh Medical
 Center, under GMP conditions.
Inclusion Criteria:

 -  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 Criteria:

 -  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.