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

NCT03353506 | Completed Phase 2 DMC

• 1 other identifier: Pro00076309
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Enterocolitis; Recurrent Clostridium Difficile Infection

Outcome Measures

Primary Outcomes (1)

• Resolution of RCDI

  Proportion of subjects without RCDI

  8 weeks

Secondary Outcomes (7)

• Resolution of RCDI

  24 weeks

• Serious Adverse Events

  8 weeks

• Serious Adverse Events

  8 weeks

• Minor Adverse Events

  1 week

• Minor Adverse Events

  1 week

Study Arms (2)

LFMT

ACTIVE COMPARATOR

Lyophilized fecal microbiota transplant capsules

Biological: LFMT

LSFF

EXPERIMENTAL

Lyophilized sterile fecal filtrate capsules

Biological: LSFF

Interventions

LFMT BIOLOGICAL

Lyophilized fecal microbiota transplant

LFMT

LSFF BIOLOGICAL

Lyophilized sterile fecal filtrate

LSFF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• CDI under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
• Ability to provide informed consent.
• Females and males must agree to use effective contraception for the duration of the study as applicable

You may not qualify if:

• 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.
• Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment.
• Taking or planning to take an investigational drug within 3 months of enrollment.
• Immunosuppression
• Chemotherapy or radiation therapy
• oropharyngeal or significant esophageal dysphagia
• Ileus or small bowel obstruction
• Subtotal colectomy
• Pregnancy or planning to become pregnant within 3 months of enrollment
• Breastfeeding or planning to breastfeed during the trial
• Active infection requiring antibiotic therapy.
• Life expectancy \<6 months -

Sponsors & Collaborators

• Dina Kao: lead
• University of Alberta: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2X8, Canada

Location

MeSH Terms

Conditions

Enterocolitis; Clostridium Infections

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Dina Kao, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: LFMT and LSFF capsules appear identical. Randomization is performed by lab staff not involved in any aspect of treatment administration or care
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Model Details: double blind randomized

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 27, 2017
• Study Start: February 14, 2018
• Primary Completion: June 5, 2019
• Study Completion: October 10, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)