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Probiotic

VE303 for C. Difficile Infection (RESTORATiVE303 Trial)

Phase 3

Recruiting

Research Sponsored by Vedanta Biosciences, Inc.

Eligibility Criteria Checklist

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

Must have

For enrollment in Stage 1: recurrent CDI population: Age ≥ 12 years with a laboratory-confirmed qualifying episode of CDI and at least one prior occurrence of CDI within the last 6 months

For enrollment in Stage 1 or 2: The qualifying episode of CDI must meet all the following criteria: New onset of ≥ 3 unformed bowel movements, CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI, Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, Diarrhea considered unlikely to have another etiology, Prior to receiving any study medication, the participant should: Receive and complete a course of SoC antibiotic therapy, Meet the criterion of a successful clinical response, Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration, Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization

Must not have

For both Stage 1 and Stage 2: History of chronic diarrhea, Laboratory-confirmed infectious diarrhea other than CDI, Known or suspected toxic megacolon or small bowel ileus, History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode of intestinal ischemia or ischemic colitis, Receipt of bezlotoxumab during the course of SoC antibiotic treatment, Receipt of genetically modified live bacterial, fungal, viral, or bacteriophage isolates, fecal-derived live bacterial isolates, or other LBPs for CDI-associated diarrhea within 6 months prior to randomization, Use of antidiarrheal drugs within 3 days prior to the planned first dose of study drug, Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Pivotal Trial

Summary

This trial aims to study the safety and recurrence rate of Clostridioides difficile infection (CDI) in participants who receive either VE303 or a placebo for 14 days. The study will

Who is the study for?

This trial is for adults, especially those over 65 or with kidney issues, who have had Clostridioides difficile infection (CDI) recently or in the past year. It's also for people with weakened immune systems, organ transplant recipients, and regular users of stomach acid reducers. Children over 12 with CDI history can join too.

What is being tested?

The RESTORATiVE303 study tests VE303 against a placebo to see if it prevents CDI from coming back within eight weeks after treatment. Participants will take either VE303 or a placebo for two weeks and be monitored for safety and recurrence.

What are the potential side effects?

Specific side effects are not listed here but generally could include typical drug reactions such as gastrointestinal discomfort, potential allergic reactions, or other unforeseen responses related to VE303.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 12 or older and have had at least two episodes of C. diff infection in the last 6 months.

Select...

I had a recent severe diarrhea episode treated successfully with antibiotics for C. diff.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CDI Recurrence Rate at Week 8

Side effects data

From 2021 Phase 2 trial • 79 Patients • NCT03788434

72%

Diarrhea

21%

Nausea

17%

Abdominal Pain

10%

Constipation

Fatigue

Dysgeusia

Blood Potassium Increased

Headache

Flatulence

Abdominal Distension

Irritable Bowel Syndrome

Abdominal Pain Upper

Chills

Cough

Transfusion Reaction

Dyspepsia

Vomiting

Urinary Tract Infection

Dehydration

100%

80%

60%

40%

20%

Study treatment Arm

VE303 High Dose

VE303 Low Dose

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VE303Experimental Treatment1 Intervention

Subjects assigned to the VE303 arm will take 3 capsules containing VE303 per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.

Group II: PlaceboPlacebo Group1 Intervention

Subjects assigned to the placebo arm will take 3 placebo capsules per day for 14 days after completing 10 to 21 days of standard of care antibiotic treatment for the qualifying CDI episode.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VE303

2021

Completed Phase 2

~140

0 / 3Eligibility criteria met