Fecal Transplantation Using a Diet for Donor and Recipient in Refractory Colitis

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Nutrition, microbiome Read More

Inclusion Criteria:

1. Informed consent
2. Established diagnosis of UC, disease confined to the large intestine, involving the rectosigmoid for at least 3 months.
3. Age: 18 - 70 years ( inclusive)
4. Mild to Moderate active disease, SCCAI of ≥5 and <10 with endoscopic subscore≥2
5. Refractory to mesalamine 6 weeks, or steroids > 14 days, or immunomodulator 12 weeks or biologics at least 12 weeks therapy.
6. No use or stable use for 2 weeks of medical cannabis.

Inclusion criteria Comments:

1. Patients can enter the trial if they are on steroids if they have been treated for at least two weeks with 40 mg prednisone or an intravenous steroid such as methylprednisolone and still suffer from a mild to moderate active disease.

Exclusion Criteria:

1. Start of a new biologic in the previous 12 weeks.
2. Evidence for Clostridium difficile infection.
3. Any proven current infection such as CMV, positive stool culture or parasite.
4. Current Extra intestinal manifestation of UC such as active arthritis or primary sclerosing cholangitis (PSC).
5. Immune deficiency (other than drug induced).
6. Current use of a calcineurin inhibitor
7. Pregnancy.
8. Suspected toxic megacolon, guarding on palpation, or signs of peritoneal inflammation
9. Patients with other IBD unrelated disease such as autoimmune disorders, renal failure, fever or current infection (UTI, strep throat, pneumonia, etc), prior or current neoplasia
10. Fecal Transplantation in the last 6 months.
11. Fever >38
12. Participation in another clinical interventional trial
13. An active malignant disease or a prior malignancy during the previous 5 years (excluding skin BCC).
14. Inability or reluctance to use an enema.
15. Anticipation for antibiotic use within the study period (such as for elective surgery or dental treatment).
16. Acute severe UC in the past 3 months.
17. Presence of a pouch or pouchitis.
18. Patients > 60 years old using chronic medications except for the treatment for colitis.

Exclusion criteria Comments:

• Patients will be excluded from the analysis if during the study and after the initial fecal transplant they did not perform the enemas, used antibiotics prior to day 42. Patients who required additional therapy such as additional FMT, steroids biologics or immunomodulators during the first 8 weeks will be considered failures on an intention to treat basis.
• Patients with mayo< 2 at the baseline colonoscopy may receive the FMT and continue the follow up according to the protocol as an open lable based on the randomization. Those patients will be excluded from the final analysis.

Special populations (e.g children, unable to sign an informed consent, those under a guardian) and pregnant women will also be excluded.

Donors:

Donors will sign an informed consent and will be screened and included only if they satisfy the rigorous screening criteria of the protocol of the Ministry of Health of Israel for stool donors for Clostridium difficile infection which includes a list of medical and behavioral conditions as well as transmissible pathogens that need to be screened by history, anthropometry, blood and stool tests (available as supplement).