|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT01433471 |
|
Date of registration:
|
06/09/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova
MUCUS |
|
Scientific title:
|
Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova |
|
Date of first enrolment:
|
August 2012 |
|
Target sample size:
|
4 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01433471 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Martin J Wolff, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
New York University School of Medicine |
|
|
Name:
|
Michael A Poles, M.D., Ph.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
New York University School of Medicine |
|
|
Name:
|
P'ng Loke, Ph.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
New York University School of Medicine |
|
|
Key inclusion & exclusion criteria
|
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 the ability to provide informed consent and be willing to keep all
scheduled appointments for the duration for the study period.
Exclusion Criteria:
- 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 white blood count <5,000 or >15,000/mm3; platelet count <150,000 per µl;
or iron or vitamin B12 deficiency. Correction of lab exclusion is allowed provided
that medical condition is not deemed to put patient at risk and stability of result is
sustained for a minimum of 30 days.
- 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.
Age minimum:
18 Years
Age maximum:
72 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Ulcerative Colitis
|
|
Intervention(s)
|
|
Drug: Trichuris suis ova
|
|
Primary Outcome(s)
|
|
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
[Time Frame: Baseline, 12 weeks, 24 weeks]
|
|
Change From Baseline of Mucus Production at 12 Weeks and 24 Weeks as Assessed by Histopathology
[Time Frame: 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
[Time Frame: 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
[Time Frame: Baseline, 12 weeks, 24 weeks]
|
|
Secondary Outcome(s)
|
|
Change From Baseline of the Simple Clinical Colitis Activity Index at 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 Weeks
[Time Frame: Baseline, 2, 4, 6, 8, 10, 14, 16, 18, 20, 22 weeks]
|
|
Change in Mayo Score From Baseline at 12 Weeks and 24 Weeks
[Time Frame: Baseline, 12 weeks, 24 weeks]
|
|
Secondary ID(s)
|
|
R#11-02470
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|