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Clostridium DifficileNCT01973465

Fecal Microbiota Therapy for Recurrent Clostridium Difficile Colitis

A study testing Stool in people with Clostridium Difficile, run by OSF Healthcare System at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for CDI. The weight of the evidence in the literature suggests that FMT is the most effective treatment for ambulatory outpatients affected by recurrent CDI who fail conventional therapy. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Clostridium Difficile
What is being tested?
Stool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Sep 2013to Sep 2014
Phase
Interventional
Are there results?
None posted in the registry

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

  • Patients > 18 years of age
  • The patient has been treated with appropriate antimicrobial therapy for CDI.
  • The patient has documented relapse/recurrence of infection as demonstrated by positive stool culture, or cytotoxin assay, or PCR toxin assay.
  • Since this study does not involve treatments that have potential teratogenicity, and in general avoidance of antimicrobial treatment during pregnancy is advised (metronidazole is pregnancy category C), women of child-bearing age may be included in the study.

Who cannot join

  • Patients will be excluded from study participation if one of the following categories of exclusion criteria applies:
  • Patient is < 18 years of age
  • Patient has an absolute neutrophil count < 750 cells/mm3.
  • Stool donors must:
  • be > 18 years of age
  • Complete a screening questionnaire:
Show all 42Show fewer
  • One-time donors: Table 1 b. Designated, pre-screened donors: Table 2
  • Be tested for communicable blood-borne and enteric pathogens:
  • One-time donors: Table 3
  • Designated, pre-screened donors: Table 4
  • Table 1: Questionnaire to screen one-time stool donors prior to FMT.
  • You have been identified as a potential stool donor by , your (spouse/ son/ daughter/ mother/ father/ life partner), who has been referred for fecal transplantation. Prior to performing the transplantation procedure, the OSF/Saint Francis Medical Center Infection Control Committee requires completion of a screening questionnaire by all potential stool donors:
  • Your name: Date: // 2013
  • Your relationship to the patient: YES / NO
  • Have you ever been diagnosed with Clostridium difficile colitis?
  • Are you currently taking antibiotic medications?
  • Have you been prescribed antibiotics in the past six weeks?
  • IF the potential stool donor answers YES to questions 1, 2, or 3 - please STOP.
  • Do you have a history of any of the following: (Please Circle)
  • Hepatitis A YES / NO Hemophilia YES / NO Hemodialysis treatment YES / NO Rejected or refused blood donation YES / NO HIV/AIDS YES / NO Hepatitis B YES / NO Hepatitis C YES / NO Use of intravenous drugs or medications YES / NO Incarceration YES / NO Abnormal blood tests of liver enzymes YES / NO Accepting money or drugs in exchange for sex YES / NO Receipt of a blood transfusion between 1977 - 1992 YES / NO Infectious gastroenteritis or diarrhea YES / NO
  • Did you answer YES to any of the above? YES / NO
  • Table 2: Questionnaire to screen designated stool donors prior to each FMT.
  • You have been identified as a potential stool donor for a patient who has been referred to Saint Francis Medical Center for fecal transplantation. Prior to performing the transplantation procedure, the OSF/Saint Francis Medical Center Infection Control Committee requires completion of a screening questionnaire by all potential stool donors:
  • Your name: Date: // 2013
  • Your relationship to the patient: YES / NO
  • 1. Have you ever been diagnosed with Clostridium difficile colitis?
  • 4. Are you currently taking antibiotic medications?
  • 5. Have you been prescribed antibiotics in the past six weeks?
  • IF the potential stool donor answers YES to questions 1, 2, or 3 - please STOP.
  • Do you have a history of any of the following: (Please Circle)
  • Hepatitis A YES / NO Hemophilia YES / NO Hemodialysis treatment YES / NO Rejected or refused blood donation YES / NO HIV/AIDS YES / NO Hepatitis B YES / NO Hepatitis C YES / NO Use of intravenous drugs or medications YES / NO Incarceration YES / NO Abnormal blood tests of liver enzymes YES / NO Accepting money or drugs in exchange for sex YES / NO Receipt of a blood transfusion between 1977 - 1992 YES / NO Infectious gastroenteritis or diarrhea YES / NO
  • Did you answer YES to any of the above? YES / NO
  • Table 3: Required stool donor screening laboratory studies prior to FMT
  • Stool:
  • Giardia \& Cryptosporidium stool antigen testing Stool ova \& parasite testing Cultures for Salmonella, Shigella and E. coli O157:H7 Clostridium difficile toxin B PCR assay
  • Blood:
  • HIV 1\&2 Ab/Ag HAV IgM Ab HBV core Ab \& Ag HCV Ab HTLV-1 Ab
  • Table 4: Laboratory studies every 120 days for designated stool donors
  • Stool:
  • Giardia \& Cryptosporidium stool antigen testing Stool ova \& parasite testing Cultures for Salmonella, Shigella and E. coli O157:H7 Clostridium difficile toxin B PCR assay
  • Blood:
  • HIV 1\&2 Ab/Ag HAV IgM Ab HBV core Ab \& Ag HCV Ab HTLV-1 Ab

Trial locations and contacts

1 site in 1 country.

April A Howarter, BSN contact

309-624-2409

April.a.howarter@osfhealthcare.org

United States1 site, 1 recruiting

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

    Recruiting

Other trials in United States

About this study

This study was developed in response to the July, 2013 FDA draft guidance regarding FMT for CDI. The weight of the evidence in the literature suggests that FMT is the most effective treatment for ambulatory outpatients affected by recurrent CDI who fail conventional therapy.

The anticipated benefits to research patients enrolled in this study include resolution of chronic diarrhea, return of bowel habits and nutritional status to normal, and resolution of chronic recurrent CDI.

FMT involves the endoscopic instillation of freshly obtained stool with millions of live bacteria into the recipient's colon by endoscopic lavage. With any endoscopic procedure, there is a risk of perforated viscous. This is very rare, but the risk is increased with severe CDI. The risk of acquisition of communicable enteric or blood borne pathogen appears to be negligible.

Being tested
Stool
Keywords
C-Diff, Diarrhea
Medical subject headings
Diarrhea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StoolBiological

    Implanting fecal matter via colonscope

Study groups in NCT01973465
Study groupRoleWhat they receive
Fecal Microbiota TherapyExperimentalNot described
Receives: Biological: Stool

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Weight and Number of bowel movements/day

    In the present study we will record each subjects weight and number of bowel movements/day prior to FMT and following FMT at 30 and 90 days.

    Measured: 30 and 90 days

Secondary outcomes (2)

  1. Evaluate the most appropriate patient population for FMT

    Our study will include ambulatory outpatients as well as hospitalized, debillitated patients. FMT has demonstrated effectiveness (both systematic reviews and RCT) for treatment of recurrent Clostridium difficile infection in ambulatory outpatient populations. A secondary outcome of our study is to evaluate stratify our patient population and examine FMT success rates for out two primary outcome measures in outpatients vs. inpatients.

    Measured: 30 and 90 days

  2. Determine the overall success of FMT

    An additional secondary outcome measure will be to examine the percent of patients who undergo 2nd or third FMT. and the success rate (in terms of primary outcome measures) for each subsequent FMT.

    Measured: 30 and 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionSep 2014 (estimated)
  4. Study completionSep 2014 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01973465
Sponsor's protocol ID
OSF-13-003
Status last verified
Oct 2013
First submitted
21 Oct 2013
Last updated
31 Oct 2013
Results posted
No
Data monitoring committee
No

Publications

  • Hall IC, O'Toole E. Intestinal flora in newborn infants with a description of a new pathogenic anaerobe, Bacillus difficilis. Am J Dis Child 1935;49:390-402.

  • Bartlett JG, Chang TW, Gurwith M, Gorbach SL, Onderdonk AB. Antibiotic-associated pseudomembranous colitis due to toxin-producing clostridia. N Engl J Med. 1978 Mar 9;298(10):531-4. doi: 10.1056/NEJM197803092981003.

    PubMed 625309

  • van Nood E, Vrieze A, Nieuwdorp M, Fuentes S, Zoetendal EG, de Vos WM, Visser CE, Kuijper EJ, Bartelsman JF, Tijssen JG, Speelman P, Dijkgraaf MG, Keller JJ. Duodenal infusion of donor feces for recurrent Clostridium difficile. N Engl J Med. 2013 Jan 31;368(5):407-15. doi: 10.1056/NEJMoa1205037. Epub 2013 Jan 16.

    PubMed 23323867

  • Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.

    PubMed 22002980

  • True E, Tsoraides S, Bonello JP. Fecal Microbiota Therapy in the Treatment of Clostridium difficile diarrhea. 63rd Annual Scientific Meeting, Illinois Chapter, American College of Surgeons. June 7, 2013.

  • Sax, PE. NEJM Journal Watch. http://blogs.jwatch.org/hiv-id-observations/index.php/fda-fecal- transplants-need-investigational-new-drug-application/2013/05/12/

Questions about this trial

What is this clinical trial studying?

A study testing Stool in people with Clostridium Difficile, run by OSF Healthcare System 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 4 inclusion and 42 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: status not confirmed, as of the sponsor's last update on 31 Oct 2013. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact April A Howarter, BSN (309-624-2409, April.a.howarter@osfhealthcare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight and Number of bowel movements/day (time frame: 30 and 90 days). 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 NCT01973465, which also lists 6 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 31 Oct 2013.

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