Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

FRESCO is a randomized, longitudinal, prospective, three arm, multicentre, double blind study to determine safety and efficacy of repeated faecal microbiota transplantation (FMT) or faecal microbiota filtrate transplantation (FMFT) compared to placebo using oral, frozen capsules in 174 randomized patients with mild to moderate active Ulcerative Colitis.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jena University Hospital
• Collaborator: German Federal Ministry of Education and Research

Criteria

Inclusion Criteria:

• Prior endoscopic confirmation of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge.

• Having active disease, defined with a Mayo Score between 4-9 and Mayo endoscopic subscore >1

• May be receiving the following drugs (subjects on these therapies must be willing to remain on stable doses for the noted times

• oral 5-ASA compounds (5-ASA) compounds provided the dose prescribed has been stable for at least 4 weeks prior to randomization; dose must be stable for first 12 weeks after randomization)

• Azathioprine, 6-Mercaptopurine (6-MP) or Methotrexate (MTX) provided the dose prescribed has been stable for 4 weeks prior to randomization; dose must be stable for first 12 weeks after randomization. Oral corticosteroid therapy (prednisone prescribed at a stable dose ≤ 20 mg/day or budesonide prescribed at a stable dose of ≤ 9 mg/day) provided the dose prescribed has been stable for 2 weeks prior to randomization.

• Ability to understand and willingness to sign informed consent document in patients whom the investigator believes can and will comply with the requirements of the protocol.

Exclusion Criteria:

• Crohn's disease or indeterminate colitis or proctitis alone

• Acute abdomen or other clinical emergencies requiring emergent management (e.g. bowel obstruction, perforation and/or abscess, previous bowel surgery)

• Concurrent gastrointestinal infections

• Other causes of diarrhoea

• Congenital or acquired immunodeficiency, severe comorbidities (e.g. diabetes mellitus, cancer, systemic lupus, decompensated cirrhosis, recent malignancy in the last 5 years)

• Pregnancy

• Patients who are unable or unwilling to undergo colonoscopy, conscious sedation with colonoscopy

• Previous treatment with TNF- or integrin-antibodies

• Any antibiotic use within the last 3 months

• Participation in a clinical trial within the last 3 months

• Prior history of FMT

• Probiotic use within 30 days of start date