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Fecal Microbiota Transplant

Fecal Transplants for Clostridium Difficile Diarrhea

Phase 2

Waitlist Available

Led By Dina Kao, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females and males must agree to effective contraception for the duration of the study

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 test, each occurring within 3 months of each other

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial will compare lyophilized fecal microbiota transplant (LFMT) to lyophilized sterile fecal filtrate (LSFF) to determine which is more effective in curing patients with recurrent Clostridioides difficile infection (CDI).

Who is the study for?

This trial is for adults who've had at least three episodes of recurrent Clostridioides difficile infection, with each episode involving multiple instances of diarrhea within a day. Participants must be able to consent and agree to use contraception. People with severe colitis, chronic diarrheal conditions not in remission, recent chemotherapy or radiation therapy, swallowing disorders, bowel obstruction, pregnancy or breastfeeding are excluded.Check my eligibility

What is being tested?

The study compares two treatments for recurrent CDI: one group receives lyophilized fecal microbiota transplant (LFMT), while the other gets lyophilized sterile fecal filtrate (LSFF). The goal is to see which treatment better restores gut bacteria balance without using live bacteria.See study design

What are the potential side effects?

Potential side effects may include discomfort at the administration site and gastrointestinal symptoms such as bloating or cramping due to the introduction of new substances into the digestive system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I agree to use effective birth control during the study.

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I've had 3 or more episodes of CDI, each with 3+ loose stools a day, confirmed by tests, within 3 months of each other.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Difficulty swallowing capsules

Fever

Minor Adverse Events

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: LSFFExperimental Treatment1 Intervention

Lyophilized sterile fecal filtrate capsules

Group II: LFMTActive Control1 Intervention

Lyophilized fecal microbiota transplant capsules

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

886 Previous Clinical Trials

384,530 Total Patients Enrolled

University of British ColumbiaOTHER

1,415 Previous Clinical Trials

2,466,768 Total Patients Enrolled

University of CalgaryOTHER

791 Previous Clinical Trials

868,486 Total Patients Enrolled

Media Library

Lyophilized fecal microbiota transplant (Fecal Microbiota Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT03806803 — Phase 2

Clostridium Difficile Colitis Research Study Groups: LFMT, LSFF

Clostridium Difficile Colitis Clinical Trial 2023: Lyophilized fecal microbiota transplant Highlights & Side Effects. Trial Name: NCT03806803 — Phase 2

Lyophilized fecal microbiota transplant (Fecal Microbiota Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03806803 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Food and Drug Administration granted its imprimatur to lyophilized sterile fecal filtrate?

"Lyophilized sterile fecal filtrate's safety score is a 2 due to its Phase 2 designation, which conveys that there has been some clinical evidence supporting safety but none for efficacy."

Answered by AI

Can you detail the locations in which this research is being conducted domestically?

"Currently, this research is being conducted at 5 sites across the country. Edmonton, Calgary and Victoria are among them; there are other two urban centres as well. To reduce your travel needs should you join in on the trial, please select a site closest to your home."

Answered by AI

To what extent has participation in this research been embraced by participants?

"This clinical trial necessitates the involvement of 248 participants that meet the predetermined criteria. Those interested in participating can do so from University Of Alberta Hospital's Edmonton, Alberta location and also from the University Of Calgary branch in Calgary, British Columbia."

Answered by AI

Are there any unfilled positions within this clinical trial?

"As mentioned on clinicaltrials.gov, this medical trial is presently enrolling participants. It was initially posted in March 21st 2019 and its information has been kept up to date as of October 31th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection

2019. "Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03806803.