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CompletedNCT03353506Updated Feb 20, 2020

Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection

A Phase 2 interventional study of LFMT and LSFF in Enterocolitis and Recurrent Clostridium Difficile Infection, sponsored by Dina Kao. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by Dina Kao · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile infection (RCDI) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with fecal slurry.

Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection (CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of recurrent Clostridium difficile infection (RCDI).

Read the detailed description

This prospective double blind randomized pilot study will enroll 40 subjects with recurrent Clostridium difficile infection in a 1:1 ratio to receive either LSFF or LFMT by capsules.

Subjects will receive 15 capsules at week 0 and be assessed at Weeks 1, 4, 12 and 24. If treatment fails, subjects will be given open label LFMT from the same donor. If treatment fails again, another FMT will be offered and the form and route of FMT delivery will be at the discretion of the treating physician.

02

Conditions studied

  • Enterocolitis
  • Recurrent Clostridium Difficile Infection
03

Who can participate

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

Inclusion criteria

  1. at least 3 episodes of recurrent CDI, with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile toxin, each occurring within 3 months of each other.
  2. CDI under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
  3. Ability to provide informed consent.
  4. Females and males must agree to use effective contraception for the duration of the study as applicable

Exclusion criteria

Exclusion Criteria:

  1. Complicated CDI defined as WBC >35, significant abdominal pain and distention, evidence of toxin megacolon or pseudomembraneous colitis, hypotension defined as systolic blood pressure \<90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring admission to intensive care.
  2. Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment.
  3. Taking or planning to take an investigational drug within 3 months of enrollment.
  4. Immunosuppression
  5. Chemotherapy or radiation therapy
  6. oropharyngeal or significant esophageal dysphagia
  7. Ileus or small bowel obstruction
  8. Subtotal colectomy
  9. Pregnancy or planning to become pregnant within 3 months of enrollment
  10. Breastfeeding or planning to breastfeed during the trial
  11. Active infection requiring antibiotic therapy.
  12. Life expectancy \<6 months -
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
11 participants (actual)

Study arms

  • Active comparator
    LFMT

    Lyophilized fecal microbiota transplant capsules

    Biological: LFMT

  • Experimental
    LSFF

    Lyophilized sterile fecal filtrate capsules

    Biological: LSFF

Interventions

  • BiologicalLFMT

    Lyophilized fecal microbiota transplant

  • BiologicalLSFF

    Lyophilized sterile fecal filtrate

05

What researchers measure

Primary outcomes

  1. Resolution of RCDI

    Proportion of subjects without RCDI

    Time frame: 8 weeks

Secondary outcomes

  1. Resolution of RCDI

    Proportion of subjects with sustained cure

    Time frame: 24 weeks

  2. Serious Adverse Events

    Mortality directly attributable to CDI or treatment

    Time frame: 8 weeks

  3. Serious Adverse Events

    Infection directly attributable to treatment

    Time frame: 8 weeks

  4. Minor Adverse Events

    nausea

    Time frame: 1 week

  5. Minor Adverse Events

    vomiting

    Time frame: 1 week

  6. Minor Adverse Events

    abdominal pain

    Time frame: 1 week

  7. Difficulty in swallowing capsules

    Reported by subjects as ranging between none, moderate or severe

    Time frame: 1 week

06

Study locations

1 site
  • University of Alberta
    Edmonton, Alberta T6G2X8, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03353506
Lead sponsor
Dina Kao
Collaborators
University of Alberta
Responsible party
Dina Kao (Medical Doctor, University of Alberta) — Sponsor-investigator
First posted
Nov 27, 2017
Start date
Feb 14, 2018
Primary completion
Jun 5, 2019
Completion
Oct 10, 2019
Last update
Feb 20, 2020

Study contacts

Dina Kao, MD
principal investigator · University of Alberta

Oversight

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

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