ClinicalTrials.Veeva

Menu

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

D

Dina Kao

Status and phase

Completed
Phase 2

Conditions

Recurrent Clostridium Difficile Infection
Enterocolitis

Treatments

Biological: LSFF
Biological: LFMT

Study type

Interventional

Funder types

Other

Identifiers

NCT03353506
Pro00076309

Details and patient eligibility

About

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).

Full 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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

  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 -

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

11 participants in 2 patient groups

LFMT
Active Comparator group
Description:
Lyophilized fecal microbiota transplant capsules
Treatment:
Biological: LFMT
LSFF
Experimental group
Description:
Lyophilized sterile fecal filtrate capsules
Treatment:
Biological: LSFF

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems