Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03843385
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jena University Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Andreas Stallmach, Prof.
Principal Investigator Affiliation Jena University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis, Inflammatory Bowel Diseases
Additional Details

Ulcerative colitis (UC) is a chronic inflammatory bowel disease with significant morbidity and mortality. Although the precise cause remains unknown, disturbances in the intestinal microbial community and changes in the crosstalk between the microbiota and the mucosal immune system have been linked to its pathogenesis. As current therapies are limited, there is a medical need for new therapies. Faecal microbiota transplantation (FMT) has been proven to be effective in managing relapsing Clostridium difficile infection (CDI) and preliminary results indicated that also the transfer of filtrates of donor stool (FMFT) drives gastrointestinal microbiota changes and eliminate symptoms in CDI patients. FRESCO is a randomized, longitudinal, prospective, three arm, multicentre, double blind study to determine safety and efficacy of repeated FMT or FMFT compared to placebo using oral, frozen capsules in 174 randomized patients with mild to moderate active UC. The primary outcome will be clinical and endoscopic remission at week 12. This proposal aims to examine: (a) the efficacy of FMT / FMFT as a therapy for mild-moderate UC, (b) the short- and long-term safety of FMT / FMFT in patients with UC and (c) the microbial and immunologic changes that occur after FMT / FMFT, to help understand how and why it works in this group of patients. All analyses will be conducted in both intention-to-treat (primary) and per-protocol (sensitivity analyses) populations, and the differences in remission rates and relapse rates between the groups will be statistically analysed to determine the efficiency of FMT versus FMFT.

Arms & Interventions

Arms

Experimental: faecal microbiota filtrate

Encapsulated faecal microbiota filtrate . 2×5 frozen capsules by mouth on 5 consecutive days per week (5 days on and 2 days off; week 1 - week 12) with water or apple juice.

Active Comparator: faecal microbiota

Encapsulated faecal microbiota. 2×5 frozen capsules by mouth on 5 consecutive days per week (5 days on and 2 days off; week 1 - week 12) with water or apple juice.

Sham Comparator: Placebo

Placebo: Encapsulated sterile saline. 2×5 frozen capsules by mouth on 5 consecutive days per week (5 days on and 2 days off; week 1 - week 12) with water or apple juice.

Interventions

Drug: - encapsulated faecal microbiota filtrate

Multidonor stool mixed with sterile normal saline, homogenized, filtered, centrifuged, air pressure filtered, encapsulated in hypromellose capsules and frozen.

Drug: - encapsulated faecal microbiota

Multidonor stool mixed with sterile normal saline, homogenized, filtered, encapsulated in hypromellose capsules and frozen.

Drug: - Placebo

Sterile saline encapsulated in hypromellose capsules and frozen.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Andreas Stallmach, Prof.

andreas.stallmach@med.uni-jena.de

+49-3641-9

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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