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Microbiota Restoration Therapy

RBX2660 for Clostridium Difficile Infection (CD3-OLS Trial)

Phase 3
Waitlist Available
Research Sponsored by Rebiotix Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks after completing the study treatment
Awards & highlights

CD3-OLS Trial Summary

This trial is testing a new way to treat recurrent C. diff infections that have not responded to standard antibiotics. The new treatment is an enema of intestinal microbes. If the initial enema does not work, subjects may receive a second enema.

Eligible Conditions
  • Clostridium Difficile (C. diff) Infection
  • Contagious Diseases
  • Infections

CD3-OLS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks after completing the study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks after completing the study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of RBX2660 in subjects with recurrent CDI.
Secondary outcome measures
Efficacy of RBX2660 measured at 8 weeks after treatment.
Sustained clinical response through 6 months after treatment.

Side effects data

From 2020 Phase 3 trial • 320 Patients • NCT03244644
20%
Diarrhoea
17%
Abdominal pain
10%
Nausea
6%
Abdominal distension
6%
Viral upper respiratory tract infection
6%
Flatulence
4%
Urinary tract infection
4%
Constipation
3%
Depression
2%
Upper respiratory tract infection
2%
Vomiting
1%
Hand fracture
1%
Rib fracture
1%
Failure to thrive
1%
Breast cancer recurrent
1%
Cardio-respiratory arrest
1%
Abdominal abscess
1%
Asthenia
1%
Clostridium difficile colitis
1%
Gait disturbance
1%
Clostridium difficile infection
1%
Confusional state
1%
Acute kidney injury
1%
Ileus
1%
Postoperative ileus
1%
Chronic obstructive pulmonary disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo Only
RBX2660 Only
Blinded Placebo/Open-label RBX2660 (Blinded Period)
Blinded RBX2660/Open-label RBX2660 (Blinded Period)
Blinded Placebo/Open-label RBX2660 (Open-label Period)
Blinded RBX2660/Open-label RBX2660 (Open-label Period)

CD3-OLS Trial Design

1Treatment groups
Experimental Treatment
Group I: ActiveExperimental Treatment1 Intervention
RBX2660 is an enema of a microbiota suspension
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RBX2660
2017
Completed Phase 3
~1410

Find a Location

Who is running the clinical trial?

Rebiotix Inc.Lead Sponsor
8 Previous Clinical Trials
815 Total Patients Enrolled
Teena Chopra, M.D., M.P.H.Study ChairWayne State University
1 Previous Clinical Trials
320 Total Patients Enrolled

Frequently Asked Questions

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

Is RBX2660 a safe medication for patients to take?

"Given that this is a Phase 3 trial with supporting efficacy data as well as multiple rounds of safety data, our team at Power has given RBX2660 a safety score of 3."

Answered by AI

Are there different research facilities across Canada conducting this investigation?

"Patients are currently being accepted at this clinical trial's 41 locations, which include places like Milwaukee, Wisconsin; Calgary, Alberta; and Shreveport, North dakota."

Answered by AI

Are doctors and patients currently being enrolled in this trial?

"This study, which was posted on July 30th 2019 and updated September 13th 2020, is currently seeking patients according to the clinicaltrials.gov website."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)
2019. "Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03931941.
~144 spots leftby Apr 2025
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