Recurrent C. Difficile Associated DiarrheaPhase 1/2NCT02318992
Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea
A Phase 1/2 study testing Fecal Microbiota in people with Recurrent C. Difficile Associated Diarrhea, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recurrent C. Difficile Associated Diarrhea
- What is being tested?
- Fecal Microbiota
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Apr 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recipients
- Male and female patients ≥ 18 years of age
- Sexually active male and female patients of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
- Female patients of child-bearing potential must have a negative pregnancy test in the 72 hours before the procedure
- Required to sign an informed consent form
- Deemed likely to survive for ≥ 3 months after enrolment
Show all 14Show fewer
- Diagnosis of ≥ 3 recurrent CDAD (RCDAD) bouts in outpatients or ≥ 2 bouts of CDAD in an inpatient without other explanation for diarrhea and with ≥ 2 positive fecal tests for C. difficile toxin
- Referred by subjects attending physician who will provide non-transplant care for the subject and follow up at 1, 7, 14, 30 days after FMT
- Received at least one course of adequate antibiotic therapy for CDAD (≥ 10 days of vancomycin at a dose of ≥125 mg four times per day, ≥ 10 days of metronidazole at a dose of 500mg three times per day or fidaxomixin 200mg twice a day for 10 days
- Anti-Clostridium difficile infection (CDI) antibiotic treatment stopped 2-4 days before the transplantation
- Donors
- Able to provide and sign informed consent
- Able to complete and sign the donor questionnaire
- Able to adhere to fecal transplantation stool collection requirements
Who cannot join
- Recipients
- Patients with neutropenia with absolute neutrophil count <0.5 x 109/L
- Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
- Peripheral white blood cell count > 15.0 x 109/L AND temperature > 38.0 °C
- Active gastroenteritis due to Salmonella, Shigella, E. coli 0157:H7, Yersinia or Campylobacter, and Norovirus
- Presence of colostomy
Show all 20Show fewer
- Unable to tolerate human biotherapy (HBT) for any reason
- Requiring systemic antibiotic therapy for more than 7 days
- Actively taking Saccharomyces boulardii or other probiotic
- Severe underlying disease such that the patient is not expected to survive for one or more years or unstable medical condition requiring daily change in treatments
- Prolonged compromised immunity due to cytotoxic chemotherapy or HIV infection
- Donors
- Test positive for any of variables
- History of any type of active cancer or autoimmune disease
- History of risk factors for acquisition of HIV, syphilis, Hepatitis B, Hepatitis C, prion or any neurological disease as determined by the donor questionnaire
- History of gastrointestinal disorder, e.g., inflammatory bowel disease, irritable bowel syndrome, chronic constipation or diarrhea
- Antibiotic use or any systemic immunosuppressive agents in the 3 months prior to stool donation
- Receipt of any type of live vaccine within 3 months prior to stool donation
- Current or previous medical or psychosocial condition
- Body mass index over 30
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Housotn
Houston, Texas, 77030
About this study
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.
- Being tested
- Fecal Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal MicrobiotaBiological
Fecal Microbiota will be delivered via colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: Fecal Microbiota |
| 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). Receives: Biological: Fecal Microbiota |
| 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. Receives: Biological: Fecal Microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Secondary outcomes (1)
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startAug 2013
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Recurrent C. Difficile Associated DiarrheaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-Dong Jiang, The University of Texas Health Science Center, Houston
- Investigators
- Herbert L DuPont, MD, Principal investigator, The University of Texas Health Science Center, HoustonZhi-Dong Jiang, MD, Dr.PH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02318992
- Sponsor's protocol ID
- HSC-SPH-13-0119
- Status last verified
- May 2024
- First submitted
- 9 Dec 2014
- Last updated
- 23 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Expanded access
- Available
Publications
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.
PubMed 23223589Mattila 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.
PubMed 22155369Hamilton 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.
PubMed 22290405Brandt LJ. Fecal transplantation for the treatment of Clostridium difficile infection. Gastroenterol Hepatol (N Y). 2012 Mar;8(3):191-4. No abstract available.
PubMed 22675283Bakken 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.
PubMed 21871249EISEMAN 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.
PubMed 13592638Brandt 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.
PubMed 21992957Borody 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.
PubMed 12811208Bennet 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.
PubMed 2563083Caporaso 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.
PubMed 22402401Edgar 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.
PubMed 20709691Caporaso 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.
PubMed 20383131
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fresh, Frozen or Lyophilized Fecal Microbiota Transplantation for Multiple Recurrent C. Difficile Associated Diarrhea
- ClinicalTrials.gov ID
- NCT02318992
- Acronym / sponsor ID
- HSC-SPH-13-0119
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Aug 2013 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 18 Dec 2014 (estimated)
- Results
- Posted 13 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota_Fresh | Active comparator | Biological: Fecal MicrobiotaDonor 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_Frozen | Active comparator | Biological: Fecal MicrobiotaDonor 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). |
| Fecal Microbiota_Lyophilized | Active comparator | Biological: Fecal MicrobiotaDonor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Recipients
- Male and female patients ≥ 18 years of age
- Sexually active male and female patients of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period
- Female patients of child-bearing potential must have a negative pregnancy test in the 72 hours before the procedure
- Required to sign an informed consent form
Key exclusion criteria (20 listed)
- Recipients
- Patients with neutropenia with absolute neutrophil count <0.5 x 109/L
- Evidence of toxic megacolon or gastrointestinal perforation on abdominal x-ray
- Peripheral white blood cell count > 15.0 x 109/L AND temperature > 38.0 °C
- Active gastroenteritis due to Salmonella, Shigella, E. coli 0157:H7, Yersinia or Campylobacter, and Norovirus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal MicrobiotaFecal Microbiota will be delivered via colonoscopy. | Biological | Fecal Microbiota_Fresh, Fecal Microbiota_Frozen, Fecal Microbiota_Lyophilized |
Primary outcome
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
Time frame: 6 months
Any untoward medical occurrence associated with the use of PRIM-DJ2727 whether or not considered drug related is considered as an adverse event (AE)
1 secondary outcome
Number of Participants Who Had a Subsequent Bout of C-diff Associated Diarrhea
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23223589Jiang 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.
- Background: PubMed 22155369Mattila 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.
- Background: PubMed 22290405Hamilton 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.
- Background: PubMed 22675283Brandt LJ. Fecal transplantation for the treatment of Clostridium difficile infection. Gastroenterol Hepatol (N Y). 2012 Mar;8(3):191-4. No abstract available.
- Background: PubMed 21871249Bakken 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.
- Background: PubMed 13592638EISEMAN 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.
- Background: PubMed 21992957Brandt 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.
- Background: PubMed 12811208Borody 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.
- Background: PubMed 2563083Bennet 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.
- Background: PubMed 22402401Caporaso 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.
- Background: PubMed 20709691Edgar 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.
- Background: PubMed 20383131Caporaso 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.
Related trials for Recurrent C. Difficile Associated Diarrhea
Recruiting
Fecal Microbiota Transplantation for C Diff Infection
Clostridium Difficile Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert L DuPont, MD principal investigator
The University of Texas Health Science Center, Houston
Zhi-Dong Jiang, MD, Dr.PH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fecal Microbiota in people with Recurrent C. Difficile Associated Diarrhea, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02318992, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.