Combination Therapy With Fecal Microbiota Transplantation and Vedolizumab for Induction of Ulcerative Colitis

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    10
  • sponsor
    McMaster University
Updated on 16 September 2021
tumor necrosis factor
microbiota
vedolizumab
fecal microbiota transplantation
enemas

Summary

The project intends to assess the polygenic burden of rare disruptive mutations in Parkinson's disease (PD) and how they influence the phenotype/pathological heterogeneity of disease.

Description

The investigators intend to extend the genetic analysis to a cohort of 300 PD cases and 300 healthy subjects (wife / husband of the patients) that will be recruited at Scientific Institute for Research, Hospitalization and Healthcare (IRCCS) Neuromed.

After signed informed consent patients will be assessed for disease progression (Hoehn and Yahr stadium, Movement Disorder Society-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS), Montreal Cognitive Assessment (MoCA) test, no motor symptoms, therapy and levodopa induced Dyskinesia (LID) occurrence). Each patient and control will be subjected to peripheral blood sampling for the isolation of DNA, RNA, plasma and serum. The investigators will use a disease-specific gene panel including about 100 genes related to Parkinson's Disease, autophagy and levodopa induced Dyskinesia (LID).

Bioinformatics analysis will allow to catalog in a database the identified variants/mutations according to their frequency and characteristics.

The investigators will specifically assess if the inheritance of multiple rare deleterious variants in Parkinson's Disease genes is predictive of disease risk.

The presence of one or more variants will be tested for association with phenotypic manifestation of Parkinson's Disease (motor, non-motor, and cognitive signs, as well as age at onset, LID and neuroimaging changes) to assess the variant burden effect on progression, and prognosis of the disease.

Details
Condition Ulcerative Colitis
Treatment Fecal Microbiota Transplantation
Clinical Study IdentifierNCT04231110
SponsorMcMaster University
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged 18 or over
Active UC defined as total Mayo score of 6 or more points, with endoscopic subscore at > 2
Clinician initiating vedolizumab for patients as per standard of care for UC
Patient previously has been exposed to one or more biologic or advanced therapies (anti-TNF, JAK inhibitor, anti-interleukin) and never previously exposed to vedolizumab or other anti-integrin therapy
Females of child bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance

Exclusion Criteria

Participating in another clinical trial
Unable to give informed consent
Severe comorbid medical illness
Concomitant Clostridium difficile infection
Increase in medical therapy for UC in the last 4 weeks. Continued treatment with 5-ASA, azathioprine, or 6-mercaptopurine will be permitted if taken at stable dose for 4 weeks prior to study entry. Stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. Stable intake of probiotic therapy also permitted
New antibiotic therapy in the last 28 days
Dose of infliximab or golimumab in prior four weeks, adalimumab in prior two weeks, or tofacitinib in prior one week
Pregnant women
Clinically significant lactose intolerance
Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject, based on lab study results
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