Clinical trial NCT02390726: Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis
Official title: Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Ulcerative Colitis, Active Moderate
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant (FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the expanding choices of medication for UC, physicians and patients are still in search of highly effective and safe medications with minimal side effects. FMT has been approved for the treatment of a bacterial infection called Clostridium difficile. In this setting, FMT has been proven to be an effective and safe alternative therapy with zero reported serious adverse events from patients that have had this treatment.

The providers that are conducting this study hypothesize that delivering microbes from a healthy human gut can help treat the damages caused by UC. This is done by "transplanting" fecal material, which contains a highly complex and dense community of healthy microbes, including bacteria, fungi and viruses. This collection of microbes is referred to as a microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.


Eligibility criteria: Inclusion Criteria:

* Men or women 18-75 years of age.
* Established diagnosis of ulcerative colitis (UC) with known involvement of the left colon
* Mild to moderate disease defined as endoscopic evidence of disease with Mayo endoscopic sub-score 1 or 2 and total MAYO score ranging from 4-10. (The Mayo score ranges from 0 to 12, with higher scores indicating more severe disease. This score can be used for both initial evaluation and monitoring treatment response).
* Patients may be on any class of IBD-related medication (excluding steroids)
* Patients must be on stable medication regimen for at least 6 weeks prior to enrollment.
* Ability to understand and willingness to sign informed consent document

Exclusion Criteria:

* Patient who are asymptomatic
* Patients with severe, refractory disease (defined as Mayo scores of \> 10, or endoscopic disease activity score of \> 3) or patients with any other significant condition which, in the opinion of the investigator, could confound or interfere with evaluation of safety, tolerability of the investigational treatment or prevent compliance with the study protocol
* Prior colectomy
* Positive stool test for any of the following: Clostridium difficile by PCR, Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic E. coli by standard stool culture.
* Use of the steroid medications (any formulation) in the prior 6 weeks to enrollment
* Systemic antibiotic use within prior 6 weeks to enrollment
* Regular probiotic supplement use within prior 48 hours to enrollment
* Pregnancy or breastfeeding
* Severe immunodeficiency, inherited or acquired (e.g. HIV, chemotherapy, or radiation therapy)
* History of anaphylaxis (severe allergic reaction)
* Documented allergy to fluoroquinolones, metronidazole
* Life expectancy less than 12 months
* Age less than 18 or greater than 75 years of age
* History of esophageal or gastric motility disorders.

Primary outcomes:
measure: Asses Endoscopic Stages of the Colon Pre/Post FMT
timeFrame: 2 years
measure: Asses Biologic Inflammatory Markers
timeFrame: 2 years
measure: Review and Track Patient reported Outcomes via Validated Questionnaires
timeFrame: 2 Years
Secondary outcomes:
measure: Change in metagenomic sequencing in Stool samples after FMT treatment
timeFrame: After 6, 12, and 18 Weeks
Other outcomes:
measure: Asses changes in T-cell measures and serotonin signaling in mucosal biopsy samples and peripheral blood samples
timeFrame: 2 years
Locations:
city: Burlington
country: United States
facility: The University of Vermont Medical Center
state: Vermont
Study officials:
affiliation: The University of Vermont Medical Center
name: Peter L Moses, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crothers JW, Chu ND, Nguyen LTT, Phillips M, Collins C, Fortner K, Del Rio-Guerra R, Lavoie B, Callas P, Velez M, Cohn A, Elliott RJ, Wong WF, Vo E, Wilcox R, Smith M, Kassam Z, Budd R, Alm EJ, Mawe GM, Moses PL. Daily, oral FMT for long-term maintenance therapy in ulcerative colitis: results of a single-center, prospective, randomized pilot study. BMC Gastroenterol. 2021 Jul 8;21(1):281. doi: 10.1186/s12876-021-01856-9.