CompletedNot Applicable

Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova

United States4 participantsStarted 2012-08

Plain-language summary

The purpose of this study is to understand the immune response activated in the human gastrointestinal tract by Trichuris Suis Ova (TSO) in patients with ulcerative colitis.

Who can participate

Age range

18 Years – 72 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects will be outpatients between the ages of 18 and 72. * Subjects must have a biopsy-proven diagnosis of ulcerative colitis for greater than three months. * There should be evidence of active disease with a total Mayo score of 6 to 10 points (scores range from 0 to 12, with higher scores indicating more severe disease activity). * There should be moderate (marked erythema, lack of vascular pattern, friability, erosions) to severe (spontaneous bleeding, ulceration) active disease on colonoscopy (Mayo endoscopic score of at least 2) at time of enrollment. * Laboratory inclusion criteria will require a hemoglobin level of \>9.0 g/dL, a white blood count between 5,000 and 15,000/μL, a platelet count of \>100,000μL, a blood urea nitrogen \< 40mg/dL, a serum creatinine of \<2.0mg/dL, a total bilirubin \< 2.5 mg/dL, and an alkaline phosphatase of \<250U/dL. * Women will be required to have a negative urine pregnancy test and to practice birth control. * The following medications will be allowed and continued throughout the study: Oral or rectal sulfasalazine, mesalamine, or mesalamine derivative (maintenance therapy of \> 8 weeks, stable dose of \> 4 weeks); Oral corticosteroid (prednisone, prednisolone, or budesonide) at an equivalent dose of a maximum of 40mg daily prednisone (maintenance therapy of \>4 weeks, stable dose of \> 2 weeks), azathioprine or 6-mercaptopurine (maintenance therapy of \> 8 weeks, stable dose of \> 4 weeks). * Subjects must have…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline of Mucus Production at 12 Weeks and 24 Weeks as Assessed by Histopathology

Timeframe: Baseline, 12 weeks, 24 weeks

Change From Baseline of Effector Lymphocyte Populations (Th1, Th2, Th17, and T-regulatory Cells) at 12 and 24 Weeks as Assessed by Flow Cytometry of Peripheral Blood Mononuclear Cells and Isolated Leukocytes From Pinch Biopsies

Timeframe: Baseline, 12 weeks, 24 weeks

Change From Baseline of Bacterial Composition and Attachment at 12 Weeks and 24 Weeks as Assessed by Real-time Polymerase Chain Reaction and 454 Sequencing of Pinch Biopsies and Stool Specimens

Timeframe: Baseline, 12 weeks, 24 weeks

Change From Baseline of Gene Expression at 12 Weeks and 24 Weeks as Assessed by Microarray and Real-time Polymerase Chain Reaction Analysis of Pinch Biopsies

Timeframe: Baseline, 12 weeks, 24 weeks

Trial details

NCT IDNCT01433471

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-05

Results submitted2016-04-26

View on ClinicalTrials.gov More Ulcerative Colitis trials

Who can participate

Age range

18 Years – 72 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change From Baseline of Mucus Production at 12 Weeks and 24 Weeks as Assessed by Histopathology

Timeframe: Baseline, 12 weeks, 24 weeks

Change From Baseline of Bacterial Composition and Attachment at 12 Weeks and 24 Weeks as Assessed by Real-time Polymerase Chain Reaction and 454 Sequencing of Pinch Biopsies and Stool Specimens

Timeframe: Baseline, 12 weeks, 24 weeks

Change From Baseline of Gene Expression at 12 Weeks and 24 Weeks as Assessed by Microarray and Real-time Polymerase Chain Reaction Analysis of Pinch Biopsies

Timeframe: Baseline, 12 weeks, 24 weeks