ClinicalTrials.gg
Sign In
TerminatedNCT03760484Updated Dec 13, 2022Results posted

Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection

A Phase 2 interventional study of Fidaxomicin 200 mg and fecal microbiota transplantation (FMT) in Clostridium Difficile, sponsored by University of Alberta. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-13.

Sponsored by University of Alberta · Phase 2, Interventional, and Treatment

Why this study was terminated
Difficulty enrolling participants/COVID pandemic/lack of continued in-kind support from product manufacturer.
Phase
Phase 2
Study type
Interventional
Enrollment
4
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Fecal microbiota transplantation (FMT) has been very effective for patients who suffer from mild C diff infection (CDI) which recurs but it is unclear how effective FMT alone is in treating severe and fulminant CDI. Current evidence suggests that FMT in combination with vancomycin is required, and that multiple treatments are necessary. The investigators think fidaxomicin may be a better option in the context and may potentially reduce the number of FMT required. However, fidaxomicin has never been used to treat severe or fulminant CDI. In this pilot study, the investigators plan to use a combination of FMT plus fidaxomicin to determine efficacy and safety in treating patients with severe or fulminant CDI. The investigators want to see if this approach may reduce the number of FMT treatment required, and/or the length of hospital stay.

Read the detailed description

In this prospective, open -label, multi--center feasibility study, the investigators aim to determine the efficacy and safety of using combined serial FMT by enema plus fidaxomicin to treat patients who have severe or fulminant CDI not responding to maximal medical therapy. The hypothesis is the combination of FMT plus fidaxomicin can reduce the number of FMT required and/or hospital length of stay compared to FMT plus vancomycin.

Participants will receive FMT by enemas over 3 days which constitutes a single cycle with concurrent treatment with oral fidaxomicin. If participants do not show improvement biochemically or clinically, then a repeat FMT cycle will be administered to a maximum of 4 cycles.

02

Conditions studied

  • Clostridium Difficile

Keywords

  • Fecal microbiota transplantation
  • Fidaxomicin
03

In context

Lead sponsor

University of Alberta is the lead sponsor of 819 studies on the registry; 168 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Browse University of Alberta studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age > 18 years with severe1 or fulminant2 CDI, without an adequate response to metronidazole IV 500 mg q8H and vancomycin 500 mg PO q6h for at least 2 days or after Fecal Microbiota Transplant (FMT). An adequate response is defined as a decrease in stool frequency or inflammatory markers (WBC or C reactive protein) by 10% over 48 hours
  • Those with ability to provide informed consent or an alternative decision maker providing assent

Exclusion criteria

Exclusion Criteria:

  • Those with bowel perforation
  • Those taking chemotherapy or radiation treatment with absolute neutrophil count of \< 1000 cells/mm3
  • Those with known colonic strictures
  • Those with subtotal colectomy or planning to have a colectomy
  • Those with significant ileus
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    fecal transplant with fidaxomicin

    FMT per rectum x 3 days in conjunction with fidaxomicin (dificid) PO 200 mg bid x 7-10 days

    Drug: Fidaxomicin 200 mg · Biological: fecal microbiota transplantation (FMT)

Interventions

  • DrugFidaxomicin 200 mg

    Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.

    Also known as: dificid

  • Biologicalfecal microbiota transplantation (FMT)

    Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles

    Also known as: biotherapy

06

What researchers measure

Primary outcomes

  1. C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT))

    Defined as \<3 unformed bowel movements/24h or return to baseline bowel habit 2 weeks after final Fecal Microbiota Transplant (FMT)

    Time frame: 2 weeks after final Fecal Microbiota Transplant (FMT)

Secondary outcomes

  1. Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT))

    Sustained C difficile infection (CDI) resolution defined as lack of C difficile infection (CDI) recurrence 8 weeks after final Fecal Microbiota Transplant (FMT)

    Time frame: 8 weeks after final Fecal Microbiota Transplant (FMT)

  2. Death

    Reported death

    Time frame: 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days

  3. Perforation

    Colonic perforation

    Time frame: 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days

  4. Infection

    Proven infection related final Fecal Microbiota Transplant (FMT)

    Time frame: 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.

  5. Hospitalization

    Hospitalization due to C. difficile infection (CDI)

    Time frame: 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.

  6. Colectomy

    Surgical Intervention - Colectomy

    Time frame: 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.

07

Results

Posted Dec 13, 2022

Participant flow

Participant flow — Overall Study
MilestoneFecal Transplant With Fidaxomicin
Started4
Completed4
Not completed0

Outcome measures

PrimaryC Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT))

Defined as \<3 unformed bowel movements/24h or return to baseline bowel habit 2 weeks after final Fecal Microbiota Transplant (FMT)

Time frame:
2 weeks after final Fecal Microbiota Transplant (FMT)
Reported as:
Count of participants · Participants
C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT))
ParticipantsFecal Transplant With Fidaxomicin
C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT))4
SecondarySustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT))

Sustained C difficile infection (CDI) resolution defined as lack of C difficile infection (CDI) recurrence 8 weeks after final Fecal Microbiota Transplant (FMT)

Time frame:
8 weeks after final Fecal Microbiota Transplant (FMT)
Reported as:
Count of participants · Participants
Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT))
ParticipantsFecal Transplant With Fidaxomicin
Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT))3
SecondaryDeath

Reported death

Time frame:
8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days
Reported as:
Count of participants · Participants
Death
ParticipantsFecal Transplant With Fidaxomicin
Death0
SecondaryPerforation

Colonic perforation

Time frame:
8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days
Reported as:
Count of participants · Participants
Perforation
ParticipantsFecal Transplant With Fidaxomicin
Perforation0
SecondaryInfection

Proven infection related final Fecal Microbiota Transplant (FMT)

Time frame:
8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.
Reported as:
Count of participants · Participants
Infection
ParticipantsFecal Transplant With Fidaxomicin
Infection0
SecondaryHospitalization

Hospitalization due to C. difficile infection (CDI)

Time frame:
8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.
Reported as:
Count of participants · Participants
Hospitalization
ParticipantsFecal Transplant With Fidaxomicin
Hospitalization0
SecondaryColectomy

Surgical Intervention - Colectomy

Time frame:
8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.
Reported as:
Count of participants · Participants
Colectomy
ParticipantsFecal Transplant With Fidaxomicin
Colectomy0

Adverse events

Collected over 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fecal Transplant With Fidaxomicin0/4 (0%)0/4 (0%)0/4 (0%)

Baseline characteristics

Age, Customized
Age, Customized(Participants)Fecal Transplant With Fidaxomicin
60-69 years1
70-79 years1
80+ years2
Sex: Female, Male
Sex: Female, Male(Participants)Fecal Transplant With Fidaxomicin
Female2
Male2
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Fecal Transplant With Fidaxomicin
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White4
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Fecal Transplant With Fidaxomicin
Canada4
08

Study locations

1 site
  • University of Alberta Hospital
    Edmonton, Alberta T6G 2X8, Canada
09

References and documents

Publications

  • Monaghan TM, Duggal NA, Rosati E, Griffin R, Hughes J, Roach B, Yang DY, Wang C, Wong K, Saxinger L, Pucic-Bakovic M, Vuckovic F, Klicek F, Lauc G, Tighe P, Mullish BH, Blanco JM, McDonald JAK, Marchesi JR, Xue N, Dottorini T, Acharjee A, Franke A, Li Y, Wong GK, Polytarchou C, Yau TO, Christodoulou N, Hatziapostolou M, Wang M, Russell LA, Kao DH. A Multi-Factorial Observational Study on Sequential Fecal Microbiota Transplant in Patients with Medically Refractory Clostridioides difficile Infection. Cells. 2021 Nov 19;10(11):3234. doi: 10.3390/cells10113234. PubMed 34831456 ↗

Study documents

  • Study protocol · Apr 21, 2020
  • Informed consent form · Jul 17, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2019 to primary completion in Mar 2020, 13 months.

Results were first posted in Dec 2022, 2 years 9 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 15, 2018
First posted
Nov 30, 2018
StartActual
Jan 21, 2019
Primary completionActual
Mar 10, 2020
CompletionActual
Mar 10, 2020
Results first posted
Dec 13, 2022
Last update
Dec 13, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03760484
Lead sponsor
University of Alberta
Responsible party
Sponsor
First posted
Nov 30, 2018
Start date
Jan 21, 2019
Primary completion
Mar 10, 2020
Completion
Mar 10, 2020
Results posted
Dec 13, 2022
Last update
Dec 13, 2022

Study contacts

Dina Kao, MD
principal investigator · University of Alberta

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Fidaxomicin

Other studies from this sponsor

University of Alberta →

Start the discussion