Darrell S. Pardi, M.D.

The purpose of this study is to assess the safety of EXE-346 after 4 weeks of treatment in subjects with an Ileal-Pouch Anal Anastomosis  (IPAA) and high bowel movement frequency.

The purpose of this study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).

The purpose of this study is to determine safety and tolerability of orally delivered R-3750 in mild to moderate patients with ulcerative colitis.

The purpose of this study is to evaluate the safety, effectovemess, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).

The purpose of this study is to establish normal sonographic parameters in patients with an ileal pouch-anal anastomosis (IPAA) and normal pouch function, and to evaluate the utility of Intestinal ultrasound (IUS) for diagnosing pouchitis and other outcomes and compare its performance with the current gold standard of pouchoscopy with biopsies.

The purpose of this study is to assess the safety, tolerability, and effectiveness of AMT-101 in subjects with chronic antibiotic-resistant pouchitis, and to select an AMT-101 dose for Phase 3.

The purpose of this study will evaluate the safety and effectiveness of VE303 for participants with recurrent Clostridium difficile infection (rCDI).

The purpose of this study is to evaluate the effectiveness, safety and tolerability of Oral Full-Spectrum MicrobiotaTM (CP101) in subjects with recurrence of Clostridium difficile infection.

The study will involve administering a single dose of investigational drug or placebo in ascending dose cohorts. This study is designed to evaluate the safety and tolerability of investigational drug as well as the efficacy of investigational drug versus placebo in adults with primary (first episode) Clostridium difficile infection (CDI).

The purpose of this study is to assess the effectiveness and safety of SER-287 in adults with active mild-to-moderate ulcerative colitis.

Subjects will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days in Treatment Group I or matching placebo once daily for 3 consecutive days in Treatment Group II. The purpose of this study is to demonstrate the superiority of SER-109 vs placebo to reduce recurrence of CDI in adults up to 8 weeks after initiation of treatment.

The purpose of this study is to assess the efficacy and safety of vedolizumab intravenous (IV) in participants with a proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis (UC) who have developed chronic or recurrent pouchitis, or require continuous antibiotic treatment.

A Phase III, multi-centre, double-blind randomised controlled trial in subjects with chronic antibiotic refractory pouchitis. Subjects will undertake a <2 week screening period to provide baseline data and be assessed for eligibility. At the Baseline visit (Day 1) eligible subjects will be randomised on a 1:1 basis to either a) 240 mg alicaforsen enema or b) matching placebo. Study drug will be administered once nightly (on going to bed) up to and including week 6. Following the Day 1 Visit, subjects will return to the clinic for safety and efficacy assessments at Week 3, 6, 10, 18 and 26. Subjects may receive certain permitted medications as per Entry Criteria, which must remain at stable doses throughout the trial. Introduction of any new medication for pouchitis, or a dose change to an existing concomitant medication for pouchitis, other than those detailed in the protocol, will not be permitted. Clinical symptoms associated with pouchitis will be recorded daily by the patient in a diary card. Subjects will undergo endoscopic examination of their pouch (during Screening, and at Weeks 6 and 10). Where technically feasible, each endoscopy will provide at least one biopsy sample for histopathology. In addition to endoscopic, histopathologic and symptomatic assessments, Quality of Life will be assessed. Bloods for routine assessment, including haematology and biochemistry will be taken. Bloods and stool samples will be collected to evaluate relevant biomarkers.

The purpose of this study is to assess if infliximab drug levels in patients who have Ulcerative Colitis predict the risk of needing a colectomy. Additionally, the investigators will estimate an optimal day 4 infliximab level based on the study results.

The purpose of this study is to extend the previous SERES-004 study in patients who had a recurrence of clostridium difficile infection within the first 8 weeks of participation.  

Subjects who had a CDI recurrence in Study SERES-012 within 8 weeks of receipt of study drug will receive an oral dose of SER-109 in 4 capsules once daily for 3 consecutive days. The purpose of this study is to assess safety and efficacy of SER-109 in reducing recurrence of Clostridium difficile infection (CDI) in adults who had a CDI recurrence within 8 weeks after receipt of SER-109 or Placebo in Study SERES-012.

The study will involve administering the study drug as a single dose of study drug or placebo. This study is designed to demonstrate the superiority of the experimental drug versus placebo in adult patients with recurrent CDI.

The purpose of this study is to evaluate the effects, safety and how OPS-2071 (150, 300, or 600 mg twice a day [BID]) is as an add-on therapy in Crohn's disease who show symptoms of active inflammation despite being on ongoing treatment.

This study is to see if PCR test developed at Mayo Clinic to diagnosis C. Difficile infections is able to predict the risk of recurrent infection.

The purpose of this study is to evaluate the safety and effectiveness of CP101 treatment in adults who had a Clostridum difficile Infection (CDI) recurrence within 8 weeks of receiving CP101 or placebo.

The purpose of the study is to ascertain the efficacy of implementation of standard treatment guidelines for the treatment of C. difficile infection based on disease severity and number of instances of this infection.