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

Recurrent Clostridium Difficile Infection Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353506
• Other study ID #: Pro00076309
• Status: Completed
• Phase: Phase 2
• Start date: February 14, 2018
• Est. completion date: October 10, 2019

Study information

• Verified date: February 2020
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 10, 2019
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 -

Related Conditions & MeSH terms

• Clostridium Infections
• Communicable Diseases
• Enterocolitis
• Infection
• Recurrent Clostridium Difficile Infection

Intervention

Biological:
• LFMT
Lyophilized fecal microbiota transplant
• LSFF
Lyophilized sterile fecal filtrate

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Dina Kao	University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of RCDI	Proportion of subjects without RCDI	8 weeks
Secondary	Resolution of RCDI	Proportion of subjects with sustained cure	24 weeks
Secondary	Serious Adverse Events	Mortality directly attributable to CDI or treatment	8 weeks
Secondary	Serious Adverse Events	Infection directly attributable to treatment	8 weeks
Secondary	Minor Adverse Events	nausea	1 week
Secondary	Minor Adverse Events	vomiting	1 week
Secondary	Minor Adverse Events	abdominal pain	1 week
Secondary	Difficulty in swallowing capsules	Reported by subjects as ranging between none, moderate or severe	1 week