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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal transplantation | Experimental | Fecal transplantation of feces from healthy donor via capsules. Oral application. |
|
| Placebo | Placebo Comparator | Placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal transplantation | Other | Fecal transplantation administered orally via frozen capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| UC remission | UC remission at week 12 defined as a Simple Clinical Colitis Activity Index<3 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in UC symptoms | defined as improvement in SCCAI | 12 weeks |
| Improvement in UC endoscopic score | Mayo-score | 12 weeks, 6 months and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilan Youngster, Dr. | Contact | 972-50-6301191 | yongsteri@asaf.health.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf-HarofehMC | Recruiting | Ẕerifin | 70300 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25938992 | Background | Drekonja D, Reich J, Gezahegn S, Greer N, Shaukat A, MacDonald R, Rutks I, Wilt TJ. Fecal Microbiota Transplantation for Clostridium difficile Infection: A Systematic Review. Ann Intern Med. 2015 May 5;162(9):630-8. doi: 10.7326/M14-2693. | |
| 27126044 | Background | Li SS, Zhu A, Benes V, Costea PI, Hercog R, Hildebrand F, Huerta-Cepas J, Nieuwdorp M, Salojarvi J, Voigt AY, Zeller G, Sunagawa S, de Vos WM, Bork P. Durable coexistence of donor and recipient strains after fecal microbiota transplantation. Science. 2016 Apr 29;352(6285):586-9. doi: 10.1126/science.aad8852. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Clinical Study Report | View IPD |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003092 | Colitis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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This is a placebo-controlled, double blinded interventional study evaluating oral, fecal microbiota transplantation, administered in patients with mild-moderate UC.
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Double Blind (Subject, Caregiver, Investigator)
| markers of inflammation | Laboratory markers of inflammation - CRP, WBC, ANC, stool calprotectin | 12 weeks, 6 months and 12 months |
| change in gut microbiome | Diversity and variability of gut microbiome | 12 weeks, 6 and 12 months. |
| use of treatments for UC | such as glucocorticoids, immunosuppressive therapy (eg, azathioprine), or tumor necrosis factor antagonists. | 6+12 months |
| Extra-intestinal disease manifestations | Extra-intestinal disease manifestations | 6 and 12 month |
| 25954111 | Background | Rossen NG, MacDonald JK, de Vries EM, D'Haens GR, de Vos WM, Zoetendal EG, Ponsioen CY. Fecal microbiota transplantation as novel therapy in gastroenterology: A systematic review. World J Gastroenterol. 2015 May 7;21(17):5359-71. doi: 10.3748/wjg.v21.i17.5359. |
| 27329806 | Background | Khoruts A, Sadowsky MJ. Understanding the mechanisms of faecal microbiota transplantation. Nat Rev Gastroenterol Hepatol. 2016 Sep;13(9):508-16. doi: 10.1038/nrgastro.2016.98. Epub 2016 Jun 22. |
| 26042318 | Background | Drekonja D, Reich J, Gezahegn S, Greer N, Shaukat A, MacDonald R, Rutks I, Wilt T. Fecal Microbiota Transplantation for Clostridium Difficile Infection: A Systematic Review of the Evidence [Internet]. Washington (DC): Department of Veterans Affairs (US); 2014 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK299000/ |
| 27109966 | Background | Scaldaferri F, Pecere S, Petito V, Zambrano D, Fiore L, Lopetuso LR, Schiavoni E, Bruno G, Gerardi V, Laterza L, Pizzoferrato M, Ianiro G, Stojanovic J, Poscia A, Papa A, Paroni Sterbini F, Sanguinetti M, Masucci L, Cammarota G, Gasbarrini A. Efficacy and Mechanisms of Action of Fecal Microbiota Transplantation in Ulcerative Colitis: Pitfalls and Promises From a First Meta-Analysis. Transplant Proc. 2016 Mar;48(2):402-7. doi: 10.1016/j.transproceed.2015.12.040. |
| 25857665 | Background | Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7. |
| 25836986 | Background | Rossen NG, Fuentes S, van der Spek MJ, Tijssen JG, Hartman JH, Duflou A, Lowenberg M, van den Brink GR, Mathus-Vliegen EM, de Vos WM, Zoetendal EG, D'Haens GR, Ponsioen CY. Findings From a Randomized Controlled Trial of Fecal Transplantation for Patients With Ulcerative Colitis. Gastroenterology. 2015 Jul;149(1):110-118.e4. doi: 10.1053/j.gastro.2015.03.045. Epub 2015 Mar 30. |
| 25322359 | Background | Youngster I, Russell GH, Pindar C, Ziv-Baran T, Sauk J, Hohmann EL. Oral, capsulized, frozen fecal microbiota transplantation for relapsing Clostridium difficile infection. JAMA. 2014 Nov 5;312(17):1772-8. doi: 10.1001/jama.2014.13875. |
| 24890442 | Background | Kelly CR, Ihunnah C, Fischer M, Khoruts A, Surawicz C, Afzali A, Aroniadis O, Barto A, Borody T, Giovanelli A, Gordon S, Gluck M, Hohmann EL, Kao D, Kao JY, McQuillen DP, Mellow M, Rank KM, Rao K, Ray A, Schwartz MA, Singh N, Stollman N, Suskind DL, Vindigni SM, Youngster I, Brandt L. Fecal microbiota transplant for treatment of Clostridium difficile infection in immunocompromised patients. Am J Gastroenterol. 2014 Jul;109(7):1065-71. doi: 10.1038/ajg.2014.133. Epub 2014 Jun 3. |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |