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

NCT01433471 | Completed Results DMC

• 1 other identifier: R#11-02470
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis; Trichuris Suis Ova; Inflammatory Bowel Disease; Mucus

Outcome Measures

Primary Outcomes (4)

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

  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

  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

  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

  Baseline, 12 weeks, 24 weeks

Secondary Outcomes (2)

• Change in Mayo Score From Baseline at 12 Weeks and 24 Weeks

  Baseline, 12 weeks, 24 weeks

• Change From Baseline of the Simple Clinical Colitis Activity Index at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 Weeks

  Baseline, 2, 4, 6, 8, 10, 14, 16, 18, 20, 22 weeks

Study Arms (2)

Trichuris suis ova followed by placebo

EXPERIMENTAL

Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover

Drug: Trichuris suis ova

Placebo followed by Trichuris Suis Ova

ACTIVE COMPARATOR

Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover

Drug: Trichuris suis ova

Interventions

Trichuris suis ova DRUG

2,500 eggs by mouth every two weeks for 12 weeks

Also known as: TSO

Placebo followed by Trichuris Suis Ova; Trichuris suis ova followed by placebo

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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 the ability to provide informed consent and be willing to keep all scheduled appointments for the duration for the study period.

You may not qualify if:

• Inpatients, pregnant patients, patients with impaired cognition, patients with a history of active substance abuse in the past six months, and children.
• Patients with a history of bowel surgery in the prior six months or who currently or previously had an ileostomy or colostomy.
• Patients with active malignancy or treatment with anticancer drugs in the past 5 years, have a history of colorectal cancer or dysplasia, or a history of neoplasm of the gastrointestinal tract.
• Female patients who are pregnant, breastfeeding, wishing to become pregnant during study participation, or unwilling to use birth control.
• Patients with stools positive for enteric pathogens, ova, or parasites at Screening
• Patients with active hepatitis B virus or hepatitis C virus infection or have been exposed to human immunodeficiency virus (HIV).
• Patients who have received an anti-tumor necrosis factor inhibitor (e.g. infliximab) within 12 weeks prior to Screening
• Patients who have received antibiotic, antifungal or antiparasitic medication in the last 2 weeks prior to Screening and/or would potentially require this during the study treatment period.
• Patients with evidence of poor compliance with medical advice and instruction including diet or medication.
• Patients who are unable or unwilling to swallow study medication suspension.
• Patients will be excluded if they have previously attempted helminthic therapy.
• There must not be evidence of fulminant colitis or a Mayo score of greater than 10
• Patients will be excluded if other clinically significant disease is present that could interfere with protocol compliance or interpretation of the results.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Limitations and Caveats

Because of the small sample size of this study, investigators decided it was not possible to draw meaningful conclusions from the outcome measures and outcome measures were not collected or analyzed as originally planned.

Results Point of Contact

• Title: Martin Wolff
• Organization: NYU Langone Medical Center

martin.wolff@nyumc.org

(646) 329-7259

Study Officials

• Michael A Poles, M.D., Ph.D.

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• P'ng Loke, Ph.D.

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Martin J Wolff, M.D.

  NYU Langone Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2011
• First Posted: September 14, 2011
• Study Start: August 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 1, 2016
• Results First Posted: June 1, 2016

Record last verified: 2016-06

Locations

US (1)