A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in in biologic-naïve patients with mild to moderate ulcerative colitis (UC).
- Category
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Trial status
Recruiting
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Trial phase
Phase 2 Drug TrialEarly stage studies investigating efficacy and safety compared to standard therapies, as well as final dose determination in moderate sized patient cohorts.
- Registry listing
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ERM Project ID
106560
Trial contact details
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Contact person
IBD Clinical Trials Team
What you need to know
Who can take part?
To participate you must:
Be aged 18 to 75
Have a documented clinical and endoscopic diagnosis of UC at least 3 months prior to study entry
Have active mild to moderate UC, as defined by the study protocol
Have never received an advanced therapy for the treatment of UC
Be on stable doses of medication as allowed by protocol
Not have any other diagnosed bowel condition
Have an allergy to VE202 or any of its components
Not be allergic to vancomycin or any of its components
Not be taking probiotics or herbal, botanical, or traditional medicinal preparations within the 2 weeks prior to study entry (consumption of food products such as yogurt, kefir, kombucha, and herbal teas is permissible)
Not have had a Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization
Have no prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
Not be pregnant or planning pregnancy
What is involved for me?
Medical history and collection of demographic information
Vital signs
Electrocardiogram
Physical exam
Blood and stool tests
Pregnancy tests for women with childbearing potential
Colonoscopy/Flexible Sigmoidoscopy with biopsy
Daily diary completion
Questionnaires
Daily tablets
Regular study visits
