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The objective of the study is to investigate the efficacy of fresh, frozen or lyophilized fecal microbiota transplantation (FMT) via colonoscopy in patients with recurrent C. difficile associated diarrhea (RCDAD). Frozen, lyophilized or fresh fecal microbiota transplantation (FMT) inoculum will be generated from well-screened healthy volunteer donors of ≥150 gram/sample. Delivery of FMT will be performed colonoscopically. Fecal samples from donors and recipients will be saved for later metagenomic studies to characterize the microbiome of the gut in patients before and after FMT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Microbiota_Fresh | Active Comparator | Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% sodium chloride (NaCl) in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was used within 2 hours of preparation (Fresh). |
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| Fecal Microbiota_Frozen | Active Comparator | Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was kept at -80 degrees Celsius (C) freezer labeled with identity (ID) and expiration date which was 6 months after preparation day (Frozen). |
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| Fecal Microbiota_Lyophilized | Active Comparator | Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 degrees celsius (C) and were used within 6 months after preparation day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota | Biological | Fecal Microbiota will be delivered via colonoscopy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety of Fresh, Frozen or Lyophilized Intestinal Bacteria From Healthy Donors Given by Colonoscopy for Therapy in Subjects With Recurrent C. Difficile Associated Diarrhea (RCDAD) as Assessed by Number of Participants Who Any Adverse Event | Any untoward medical occurrence associated with the use of PRIM-DJ2727 whether or not considered drug related is considered as an adverse event (AE) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had a Subsequent Bout of C-diff Associated Diarrhea | a subsequent bout of C-diff associated diarrhea was defined as diarrhea, C. difficile toxins positive and using anti-C. difficile antibiotic treatment | 30 days |
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Inclusion Criteria:
Recipients
Donors
Exclusion Criteria:
Recipients
Donors
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| Name | Affiliation | Role |
|---|---|---|
| Herbert L DuPont, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Zhi-Dong Jiang, MD, Dr.PH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at Housotn | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23223589 | Background | Jiang ZD, Hoang LN, Lasco TM, Garey KW, Dupont HL. Physician attitudes toward the use of fecal transplantation for recurrent Clostridium difficile infection in a metropolitan area. Clin Infect Dis. 2013 Apr;56(7):1059-60. doi: 10.1093/cid/cis1025. Epub 2012 Dec 7. No abstract available. | |
| 22155369 | Background |
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79 were enrolled; however only 78 started--this is because one person who enrolled withdrew before treatment initiation due to insurance problem.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fecal Microbiota_Fresh | Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% sodium chloride (NaCl) in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250 milliliters (mL)) was used within 2 hours of preparation (Fresh). Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 15, 2017 |
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| Mattila E, Uusitalo-Seppala R, Wuorela M, Lehtola L, Nurmi H, Ristikankare M, Moilanen V, Salminen K, Seppala M, Mattila PS, Anttila VJ, Arkkila P. Fecal transplantation, through colonoscopy, is effective therapy for recurrent Clostridium difficile infection. Gastroenterology. 2012 Mar;142(3):490-6. doi: 10.1053/j.gastro.2011.11.037. Epub 2011 Dec 7. |
| 22290405 | Background | Hamilton MJ, Weingarden AR, Sadowsky MJ, Khoruts A. Standardized frozen preparation for transplantation of fecal microbiota for recurrent Clostridium difficile infection. Am J Gastroenterol. 2012 May;107(5):761-7. doi: 10.1038/ajg.2011.482. Epub 2012 Jan 31. |
| 22675283 | Background | Brandt LJ. Fecal transplantation for the treatment of Clostridium difficile infection. Gastroenterol Hepatol (N Y). 2012 Mar;8(3):191-4. No abstract available. |
| 21871249 | Background | Bakken JS, Borody T, Brandt LJ, Brill JV, Demarco DC, Franzos MA, Kelly C, Khoruts A, Louie T, Martinelli LP, Moore TA, Russell G, Surawicz C; Fecal Microbiota Transplantation Workgroup. Treating Clostridium difficile infection with fecal microbiota transplantation. Clin Gastroenterol Hepatol. 2011 Dec;9(12):1044-9. doi: 10.1016/j.cgh.2011.08.014. Epub 2011 Aug 24. |
| 13592638 | Background | EISEMAN B, SILEN W, BASCOM GS, KAUVAR AJ. Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis. Surgery. 1958 Nov;44(5):854-9. No abstract available. |
| 21992957 | Background | Brandt LJ, Reddy SS. Fecal microbiota transplantation for recurrent clostridium difficile infection. J Clin Gastroenterol. 2011 Nov;45 Suppl:S159-67. doi: 10.1097/MCG.0b013e318222e603. |
| 12811208 | Background | Borody TJ, Warren EF, Leis S, Surace R, Ashman O. Treatment of ulcerative colitis using fecal bacteriotherapy. J Clin Gastroenterol. 2003 Jul;37(1):42-7. doi: 10.1097/00004836-200307000-00012. |
| 2563083 | Background | Bennet JD, Brinkman M. Treatment of ulcerative colitis by implantation of normal colonic flora. Lancet. 1989 Jan 21;1(8630):164. doi: 10.1016/s0140-6736(89)91183-5. No abstract available. |
| 22402401 | Background | Caporaso JG, Lauber CL, Walters WA, Berg-Lyons D, Huntley J, Fierer N, Owens SM, Betley J, Fraser L, Bauer M, Gormley N, Gilbert JA, Smith G, Knight R. Ultra-high-throughput microbial community analysis on the Illumina HiSeq and MiSeq platforms. ISME J. 2012 Aug;6(8):1621-4. doi: 10.1038/ismej.2012.8. Epub 2012 Mar 8. |
| 20709691 | Background | Edgar RC. Search and clustering orders of magnitude faster than BLAST. Bioinformatics. 2010 Oct 1;26(19):2460-1. doi: 10.1093/bioinformatics/btq461. Epub 2010 Aug 12. |
| 20383131 | Background | Caporaso JG, Kuczynski J, Stombaugh J, Bittinger K, Bushman FD, Costello EK, Fierer N, Pena AG, Goodrich JK, Gordon JI, Huttley GA, Kelley ST, Knights D, Koenig JE, Ley RE, Lozupone CA, McDonald D, Muegge BD, Pirrung M, Reeder J, Sevinsky JR, Turnbaugh PJ, Walters WA, Widmann J, Yatsunenko T, Zaneveld J, Knight R. QIIME allows analysis of high-throughput community sequencing data. Nat Methods. 2010 May;7(5):335-6. doi: 10.1038/nmeth.f.303. Epub 2010 Apr 11. No abstract available. |
| FG001 | Fecal Microbiota_Frozen | Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% sodium chloride (NaCl) in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was kept at -80 degrees celsius (C) freezer labeled with identity (ID) and expiration date which was 6 months after preparation day (Frozen). Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy. |
| FG002 | Fecal Microbiota_Lyophilized | Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250 milliliters (mL)) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 degrees celsius (C) and were used within 6 months after preparation day. Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy. |
| COMPLETED |
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| NOT COMPLETED |
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One patient withdraw from the study before starting the procedure
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| ID | Title | Description |
|---|---|---|
| BG000 | Fecal Microbiota_Fresh | Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% sodium chloride (NaCl) in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was used within 2 hours of preparation (Fresh). Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy. |
| BG001 | Fecal Microbiota_Frozen | Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was kept at -80 degrees celsius (C) freezer labeled with ID and expiration date which was 6 months after preparation day (Frozen). Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy. |
| BG002 | Fecal Microbiota_Lyophilized | Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 milliliters (mL) (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 degrees celsius (C) and were used within 6 months after preparation day. Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Number of Patients with Inflammatory bowel disease | Count of Participants | Participants |
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| Number of Patients with Ulcerative Colitis | Count of Participants | Participants |
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| Number of Patients with Crohn's Disease | Count of Participants | Participants |
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| Number of Patients used Anti-C. difficile infection (CDI) treatment 6 months before the procedure | Count of Participants | Participants |
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| duration since last Clostridium difficile infection (CDI) bout in 0.5 month increments | Mean | Standard Deviation | half months |
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| total number Clostridium difficile infection (CDI) bouts before fecal microbiota transplantation | Mean | Standard Deviation | counts |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Safety of Fresh, Frozen or Lyophilized Intestinal Bacteria From Healthy Donors Given by Colonoscopy for Therapy in Subjects With Recurrent C. Difficile Associated Diarrhea (RCDAD) as Assessed by Number of Participants Who Any Adverse Event | Any untoward medical occurrence associated with the use of PRIM-DJ2727 whether or not considered drug related is considered as an adverse event (AE) | One subject in the Fecal Microbiota_Fresh group was lost to follow up. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | Number of Participants Who Had a Subsequent Bout of C-diff Associated Diarrhea | a subsequent bout of C-diff associated diarrhea was defined as diarrhea, C. difficile toxins positive and using anti-C. difficile antibiotic treatment | One subject in the Fecal Microbiota_Fresh group was lost to follow up. | Posted | Count of Participants | Participants | 30 days |
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6 months
Although 27 started in the Fecal Microbiota_Fresh group, only 26 were indicated as "at risk" because one person in the Fecal Microbiota_Fresh group was lost to follow up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fecal Microbiota_Fresh | Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250 mL) was used within 2 hours of preparation (Fresh). Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy. | 0 | 26 | 0 | 26 | 2 | 26 |
| EG001 | Fecal Microbiota_Frozen | Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250 mL) was kept at -80 C freezer labeled with ID and expiration date which was 6 months after preparation day (Frozen). Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy. | 1 | 27 | 1 | 27 | 2 | 27 |
| EG002 | Fecal Microbiota_Lyophilized | Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250 mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 C and were used within 6 months after preparation day. Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy. | 0 | 24 | 1 | 24 | 6 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urosepsis | Infections and infestations | Systematic Assessment |
| ||
| Colitis and enteritis with cholelithiasis | Gastrointestinal disorders | Systematic Assessment | Six days after FMT patient developed acute stomach pain and fever with white blood cell (WBC) 40K. Computed tomography (CT) showed colitis and enteritis with cholelithiasis. Stool was negative for C. difficile toxin. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gastrointestinal complaints | Gastrointestinal disorders | Systematic Assessment | gastrointestinal complaints including abdominal cramps, lost appetite, nausea, vomiting |
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| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
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| blood clot | Blood and lymphatic system disorders | Systematic Assessment | subject had blood clot rectally |
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Microbiota analyses was not performed on the subjects with Fecal Microbiota Transplantation (FMT) failure who could not provide four stools. Microbiota was not studied at the species level. Limited sample size of the study.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Herbert DuPont | University of Texas School of Public Health | 713 500 9366 | herbert.l.dupont@uth.tmc.edu |
| Mar 25, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| OG002 | Fecal Microbiota_Lyophilized | Donor stool (greater than 150 grams) was collected <4 hours prior to the procedure and then mixed in a homogenizer with 1500 mL (1:10 dilution) sterilized 0.9% NaCl in a large sterilized suction canister until a smooth consistency was reached. The suspension was filtered using a coffee filter twice. The microbiota suspension (250mL) was starting lyophilization process within 30 minutes after completion of stool filtration (Lyophilized). Lyophilized microbiota products were kept at 4 C and were used within 6 months after preparation day. Fecal Microbiota: Fecal Microbiota will be delivered via colonoscopy. |
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