Ulcerative ColitisMUCUSNCT01433471

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

A study testing Trichuris suis ova in people with Ulcerative Colitis, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 72 years
Conditions the study is for: Ulcerative Colitis
What is being tested?: Trichuris suis ova
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: Aug 2012to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 72 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 14Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

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.

Read the detailed description

The concept of helminthic therapy (using worms to treat diseases) is supported by experiments in mouse models as well as several clinical studies. TSO, which are purified eggs from the porcine whipworm Trichuris suis, are being investigated in clinical trials as a potential therapeutic agent for the treatment of active Crohn's disease, relapsing multiple sclerosis, peanut and tree nut allergy, and adults with autistic disorders.

The goal of this study is to understand the immune mechanisms activated in the human gastrointestinal tract by treatment with TSO, which may lead to improvements in the symptoms of ulcerative colitis (UC). TSO have been shown to have a clinical benefit on a subset of patients with UC in a previous randomized placebo-controlled trial (Summers et al. 2005). However, the mechanisms of action of TSO on the intestinal mucosa remain unclear.

We propose an exploratory 24-week mechanistic randomized double-blind placebo-controlled crossover study of TSO in patients with established and active UC to better characterize similarities and differences in the immune mechanisms of the intestinal mucosa in response to TSO. We hypothesize that treatment with TSO will lead to an anti-inflammatory immune response in some individuals with UC through an increase in intestinal mucus production and modulation of Th1, Th2, Th17, and T-regulatory effector lymphocyte populations.

Conditions: Ulcerative Colitis
Being tested: Trichuris suis ova
Keywords: Ulcerative Colitis, Trichuris Suis Ova, Inflammatory Bowel Disease, Mucus
Medical subject headings: Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trichuris suis ovaDrug
Also called TSO
2,500 eggs by mouth every two weeks for 12 weeks

Study groups in NCT01433471
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Trichuris suis ova

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline of Mucus Production at 12 Weeks and 24 Weeks as Assessed by Histopathology
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 12 weeks, 24 weeks

Secondary outcomes (2)

Change in Mayo Score From Baseline at 12 Weeks and 24 Weeks
To assess ulcerative colitis disease activity
Measured: 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
To assess ulcerative colitis disease activity without requiring endoscopy
Measured: Baseline, 2, 4, 6, 8, 10, 14, 16, 18, 20, 22 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012May 2015

First posted14 Sep 2011 (estimated)
Study startAug 2012
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01433471
Sponsor's protocol ID: R#11-02470
Acronym: MUCUS
Status last verified: Jun 2016
First submitted: 6 Sep 2011
Last updated: 1 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Ulcerative Colitis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova
ClinicalTrials.gov ID: NCT01433471
Acronym / sponsor ID: MUCUS / R#11-02470
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis, Trichuris Suis Ova, Inflammatory Bowel Disease, Mucus
Study type: Interventional
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: Aug 2012
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 14 Sep 2011 (estimated)
Results: Posted 1 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Trichuris suis ova followed by placebo	Experimental	Drug: Trichuris suis ovaSubjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover
Placebo followed by Trichuris Suis Ova	Active comparator	Drug: Trichuris suis ovaSubjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover

Who may qualify

Ages: 18 to 72 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Trichuris suis ovaAlso: TSO2,500 eggs by mouth every two weeks for 12 weeks	Drug	Placebo followed by Trichuris Suis Ova, Trichuris suis ova followed by placebo

Primary outcome

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 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
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 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

2 secondary outcomes

Change in Mayo Score From Baseline at 12 Weeks and 24 Weeks
Time frame: 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
Time frame: Baseline, 2, 4, 6, 8, 10, 14, 16, 18, 20, 22 weeks

Results and safety

Results posted to the registry on 1 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trichuris Suis Ova Followed by Placebo	2	2
Placebo Followed by Trichuris Suis Ova	2	1

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

Time frame: Baseline, 12 weeks, 24 weeks

Population analysed: 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. Therefore, no outcome measure data is available.

Primary outcome: 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

Primary outcome: 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

Primary outcome: 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

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Trichuris Suis Ova	0 of 3 (0%)	3 of 3 (100%)	Not reported
Placebo	0 of 4 (0%)	4 of 4 (100%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael A Poles, M.D., Ph.D. principal investigator

NYU Langone Health

P'ng Loke, Ph.D. principal investigator

NYU Langone Health

Martin J Wolff, M.D. study director

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Trichuris suis ova in people with Ulcerative Colitis, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline of Mucus Production at 12 Weeks and 24 Weeks as Assessed by Histopathology (time frame: Baseline, 12 weeks, 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01433471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.