Clinical trial NCT03353506: Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection
Official title: A Prospective Double Blind Randomized Pilot Study Comparing the Efficacy of Lyophilized Fecal Microbiota Transplantation (FMT) to Lyophilized Sterile Fecal Filtrate in the Management of Recurrent Clostridium Difficile Infection (CDI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Enterocolitis
Recurrent Clostridium Difficile Infection
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: University of Alberta
First posted: 2017-11-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: double blind randomized
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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 -

Primary outcomes:
measure: Resolution of RCDI
timeFrame: 8 weeks
Secondary outcomes:
measure: Resolution of RCDI
timeFrame: 24 weeks
measure: Serious Adverse Events
timeFrame: 8 weeks
measure: Serious Adverse Events
timeFrame: 8 weeks
measure: Minor Adverse Events
timeFrame: 1 week
measure: Minor Adverse Events
timeFrame: 1 week
measure: Minor Adverse Events
timeFrame: 1 week
measure: Difficulty in swallowing capsules
timeFrame: 1 week
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Dina Kao, MD
role: PRINCIPAL_INVESTIGATOR
References: