Colitis, UlcerativePhase 2NCT01953354
Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis
A Phase 2 study testing Trichuris suis ova (TSO) in people with Colitis, Ulcerative, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- Trichuris suis ova (TSO)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 17 sitesUnited States
- Study dates
- Nov 2013to Nov 2015
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided written informed consent
- Diagnosis of UC (newly diagnosed or established patients) as determined by medical history, endoscopic and histological confirmation with the proximal disease extent limited to the left colon (distal to the splenic flexure), and accessible by flexible sigmoidoscopy. Patients with left-sided disease and the presence of a periappendiceal red patch (limited cecal inflammation) will be eligible as long as there is no intervening evidence of colitis between the cecal base and the upper boundary of inflammation in the left colon.
- Mayo score >/= 4, as scored at Screen 2
- If taking the following medications at Screen 1, subjects must meet the following criteria:
- Oral Corticosteroids: stable treatment for at least 4 weeks prior to Day 0 with a maximum dose equivalent to <\=15 mg/day of prednisone
- Immunosuppressants (azathioprine (AZA) or 6-mercaptopurine (6-MP)): treatment for at least 12 weeks with a stable dose, not exceeding 2.5 mg/kg/day of AZA or 1.5 mg/kg/day of 6-MP, during the 4 weeks prior to Day 0
- Aminosalicylates: stable oral doses up to 4.8 g/day for at least 4 weeks prior to Day 0.
Who cannot join
- Subjects whose UC is anticipated to require surgical, endoscopic, or radiologic intervention during study participation
- Uncontrolled GI bleeding
- Subjects who have disease limited to the rectum (maximum disease extent of less than 15 cm)
- Women who are pregnant, breast-feeding, or planning to become pregnant during the study. All women of childbearing potential must have a negative serum pregnancy test at Screen 2 prior to randomization of treatment.
- Women of childbearing potential not using adequate birth control measures (e.g., total abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization, Depo-Provera, or hormonal implants).
- Current or recent serious systemic disorder including clinically significant impairment in cardiac, pulmonary, liver, renal, endocrine, hematologic, or neurologic function, based on investigator discretion
Show all 37Show fewer
- Subjects currently receiving the following concomitant medications:
- Prednisone or its equivalent at unstable doses or at doses exceeding 15 mg/day within 4 weeks prior to Day 0
- Local steroids such as budesonide, Colifoam, or Predsol enemas within 2 weeks prior to Screen 2
- Topical therapies, either mesalamine or steroids, taken within 2 weeks of Screen 2
- Non-steroidal anti-inflammatory drugs (NSAIDs), Cyclooxygenase (COX)-2 inhibitors, or aspirin >100 mg/day within 2 weeks prior to Screen 2
- Tumor necrosis factor (TNF)-alpha inhibitors including but not limited to infliximab (Remicade) or adalimumab (Humira) within 12 weeks of Day 0
- Any biological agent within 12 weeks of Day 0
- Metronidazole within 4 weeks of Day 0
- Receipt of any investigational agent within the 12 weeks prior to Day 0
- Antibacterial or oral antifungal agents within 4 weeks of Screen 2
- Interferon (IFN) therapy
- Anticoagulants
- Methotrexate
- Blood transfusion within the 12 weeks prior to Day 0
- Presence of any of the following abnormal laboratory parameters at Screen 1:
- Hemoglobin < 10.0 g/dL
- White Blood Count (WBC) < 4,000 or > 20,000/L (equivalent to WBC < 4 or > 20 x109/L)
- Platelets < 100,000 or > 800,000/L (equivalent to platelets < 100 or > 800 x109/L)
- Total bilirubin > 1.5 × Upper limit of normal (ULN)
- Alanine transaminase (ALT) > 2 × ULN
- Aspartate transaminase (AST) > 2 × ULN
- Alkaline phosphatase (ALK) > 1.5 × ULN
- Gamma-glutamyl transferase (GGT) > 1.5 × ULN
- Creatinine > 1.5 × ULN
- History of drug or alcohol abuse within one year prior to Day 0
- Inability to understand the nature and requirements of the study, or to comply with the study procedures or planned schedule of study visits
- Evidence of infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- Active infection with C. difficile, bacterial enteric pathogens, or pathogenic ova/parasites
- History of malignancy within the last 5 years, except for resected basal or squamous cell carcinoma, treated cervical dysplasia, or treated in situ cervical cancer Grade I
- History of colonic dysplasia
- Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Maryland
Baltimore, Maryland, 21201
Tufts Medical Center
Boston, Massachusetts, 02111
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa Hospital
Iowa City, Iowa, 52242
University of Miami Miller School of Medicine
Miami, Florida, 33136
Vanderbilt University
Nashville, Tennessee, 37212
Yale University
New Haven, Connecticut, 06510
Weill Cornell Medical College
New York, New York, 10021
Stanford University School of Medicine
Palo Alto, California, 94305
Drexel University
Philadelphia, Pennsylvania, 19103
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Mayo Clinic
Rochester, Minnesota, 55905
Virginia Mason Medical Center
Seattle, Washington, 98101
About this study
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study of Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis and Its Effects on Mucosal Immune State and Microbiota
The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC.
Read the detailed description
The cause of UC, an inflammatory bowel disease (IBD), is not well understood. It is believed to be caused from an abnormal immune response to the normal bacteria that live in the gut (intestines and colon). This response acts as an "attack" on the healthy tissue of the bowel by a person's own immune cells which leads to disease.
It is well known that autoimmune diseases such as IBD, asthma, diabetes, and multiple sclerosis are more common in industrialized, well-developed countries with better sanitation and hygiene, as in the United States. These "cleaner" environments reduce exposure to germs and parasites naturally found in the environment. This reduced exposure may trigger responses in the body that make people more prone to diseases such as UC. People in non-industrialized countries and the tropics, where parasites are common, rarely develop these diseases. This observation has led researchers to want to better understand the relationship between the lack of natural bacteria in the gut and the onset of autoimmune diseases like as UC.
- Conditions
- Colitis, Ulcerative
- Being tested
- Trichuris suis ova (TSO), Placebo
- Keywords
- Ulcerative colitis (UC), Inflammatory Bowel Disease (IBD), Trichuris suis ova (TSO)
- 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 ova (TSO)Biological
Also called T. suis ova, 7500 Trichuris suis ova (7500 TSO ), CNDO 201
Six doses of TSO orally over a ten-week period (e.g., every 2 weeks x 10 weeks for a total of 6 total doses)
PlaceboBiological
Also called Trichuris suis ova (TSO) placebo
Six doses of TSO placebo orally over a ten-week period (e.g., every 2 weeks x 10 weeks for a total of 6 total doses)
| Study group | Role | What they receive |
|---|---|---|
| Trichuris suis ova (TSO) | Experimental | Six doses of TSO orally over a ten-week period Receives: Biological: Trichuris suis ova (TSO) |
| Placebo | Placebo comparator | Six doses of TSO placebo orally over a ten-week period Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Achieved a Clinical Response at Week 12
Clinical response is defined as a reduction in the Mayo score of at least 3 points and at least a 30% reduction from Baseline, along with either a decrease from Baseline in the rectal bleeding subscore of more than 1 point or a rectal bleeding subscore of 0 or 1.
Measured: Week 12
Secondary outcomes (7)
Percent of Participants Who Achieved Remission at Week 12
Remission is defined as a Mayo score of less than or equal to 1 with absence of rectal bleeding and endoscopy score of 0 or 1.
Measured: Week 12
Percent of Participants With Healed Colonic Mucosa at Week 12
Healed colonic mucosa is defined as a Mayo endoscopy score of 0 or 1.
Measured: Week 12
Percent of Participants With a Modified Clinical Response
Modified clinical response is defined as a reduction in the modified Mayo score (i.e., minus the endoscopy component) of at least 2 points from baseline.
Measured: From Day 0 through time of first clinical response or end of follow-up, whichever comes first, up to 12 Weeks
Time to Modified Clinical Response
Number of days to reach a modified clinical response. Modified clinical response is defined as a reduction in the modified Mayo score (i.e., minus the endoscopy component) of at least 2 points from baseline.
Measured: From Baseline through the day that modified clinical response is reached. Week 16 is the last visit that the modified Mayo score is assessed.
Percent of Participants With Colonoscopic Evidence of Visible Worm
Stool evaluations for ova and parasites confirmed the absence of T. suis. If evidence suggested a presence of T. suis, a colonoscopy would be performed to confirm invasion with a visible worm.
Measured: From Day 0 through end of follow-up, up to 36 weeks
Percent of Participants With Increase in Diarrhea
An increase in diarrhea is defined as an increase in the Mayo Score's Stool Frequency score by at least 1 point from baseline at any time during follow-up.
Measured: From Day 0 through end of follow-up, up to 36 weeks
Percent of Participants With Increase in Concurrent Ulcerative Colitis (UC) Medications or New Rescue Medications Added
New or increase in UC medications is defined as a need for dose-escalation of concurrent medications or need for rescue medications to treat UC through Week 16.
Measured: From Day 0 through Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: MFR's business decision to d/c TSO production -unrelated to any safety concern.
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Coronado Biosciences, Inc., Autoimmunity Centers of Excellence
- Responsible party
- Sponsor
- Investigators
- Stephen Hanauer, MD, Study chair, Northwestern UniversityBana Jabri, MD, PhD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953354
- Sponsor's protocol ID
- DAIT AUC02
- Status last verified
- Feb 2017
- First submitted
- 24 Sep 2013
- Last updated
- 17 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Summers RW, Elliott DE, Qadir K, Urban JF Jr, Thompson R, Weinstock JV. Trichuris suis seems to be safe and possibly effective in the treatment of inflammatory bowel disease. Am J Gastroenterol. 2003 Sep;98(9):2034-41. doi: 10.1111/j.1572-0241.2003.07660.x.
PubMed 14499784Moreels TG, Pelckmans PA. Gastrointestinal parasites: potential therapy for refractory inflammatory bowel diseases. Inflamm Bowel Dis. 2005 Feb;11(2):178-84. doi: 10.1097/00054725-200502000-00012.
PubMed 15677912Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. doi: 10.1016/S0140-6736(07)60750-8.
PubMed 17499605
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study of Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis and Its Effects on Mucosal Immune State and Microbiota
- ClinicalTrials.gov ID
- NCT01953354
- Acronym / sponsor ID
- DAIT AUC02
- Conditions
- Colitis, Ulcerative
- Keywords
- Ulcerative colitis (UC), Inflammatory Bowel Disease (IBD), Trichuris suis ova (TSO)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: MFR's business decision to d/c TSO production -unrelated to any safety concern.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Coronado Biosciences, Inc., Autoimmunity Centers of Excellence
- Study start
- Nov 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Posted 10 Feb 2017
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 evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC.
Detailed description
The cause of UC, an inflammatory bowel disease (IBD), is not well understood. It is believed to be caused from an abnormal immune response to the normal bacteria that live in the gut (intestines and colon). This response acts as an "attack" on the healthy tissue of the bowel by a person's own immune cells which leads to disease.
It is well known that autoimmune diseases such as IBD, asthma, diabetes, and multiple sclerosis are more common in industrialized, well-developed countries with better sanitation and hygiene, as in the United States. These "cleaner" environments reduce exposure to germs and parasites naturally found in the environment. This reduced exposure may trigger responses in the body that make people more prone to diseases such as UC. People in non-industrialized countries and the tropics, where parasites are common, rarely develop these diseases. This observation has led researchers to want to better understand the relationship between the lack of natural bacteria in the gut and the onset of autoimmune diseases like as UC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trichuris suis ova (TSO) | Experimental | Biological: Trichuris suis ova (TSO)Six doses of TSO orally over a ten-week period |
| Placebo | Placebo comparator | Biological: PlaceboSix doses of TSO placebo orally over a ten-week period |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject has provided written informed consent
- Diagnosis of UC (newly diagnosed or established patients) as determined by medical history, endoscopic and histological confirmation with the proximal disease extent limited to the left colon (distal to the splenic flexure), and accessible by flexible sigmoidoscopy. Patients with left-sided disease and the presence of a periappendiceal red patch (limited cecal inflammation) will be eligible as long as there is no intervening evidence of colitis between the cecal base and the upper boundary of inflammation in the left colon.
- Mayo score >/= 4, as scored at Screen 2
- If taking the following medications at Screen 1, subjects must meet the following criteria:
Key exclusion criteria (37 listed)
- Subjects whose UC is anticipated to require surgical, endoscopic, or radiologic intervention during study participation
- Uncontrolled GI bleeding
- Subjects who have disease limited to the rectum (maximum disease extent of less than 15 cm)
- Women who are pregnant, breast-feeding, or planning to become pregnant during the study. All women of childbearing potential must have a negative serum pregnancy test at Screen 2 prior to randomization of treatment.
- Women of childbearing potential not using adequate birth control measures (e.g., total abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization, Depo-Provera, or hormonal implants).
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 ova (TSO)Also: T. suis ova, 7500 Trichuris suis ova (7500 TSO ), CNDO 201Six doses of TSO orally over a ten-week period (e.g., every 2 weeks x 10 weeks for a total of 6 total doses) | Biological | Trichuris suis ova (TSO) |
| PlaceboAlso: Trichuris suis ova (TSO) placeboSix doses of TSO placebo orally over a ten-week period (e.g., every 2 weeks x 10 weeks for a total of 6 total doses) | Biological | Placebo |
Primary outcome
Percentage of Participants Who Achieved a Clinical Response at Week 12
Time frame: Week 12
Clinical response is defined as a reduction in the Mayo score of at least 3 points and at least a 30% reduction from Baseline, along with either a decrease from Baseline in the rectal bleeding subscore of more than 1 point or a rectal bleeding subscore of 0 or 1.
7 secondary outcomes
Percent of Participants Who Achieved Remission at Week 12
Time frame: Week 12
Percent of Participants With Healed Colonic Mucosa at Week 12
Time frame: Week 12
Percent of Participants With a Modified Clinical Response
Time frame: From Day 0 through time of first clinical response or end of follow-up, whichever comes first, up to 12 Weeks
Time to Modified Clinical Response
Time frame: From Baseline through the day that modified clinical response is reached. Week 16 is the last visit that the modified Mayo score is assessed.
Percent of Participants With Colonoscopic Evidence of Visible Worm
Time frame: From Day 0 through end of follow-up, up to 36 weeks
Percent of Participants With Increase in Diarrhea
Time frame: From Day 0 through end of follow-up, up to 36 weeks
Percent of Participants With Increase in Concurrent Ulcerative Colitis (UC) Medications or New Rescue Medications Added
Time frame: From Day 0 through Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14499784Summers RW, Elliott DE, Qadir K, Urban JF Jr, Thompson R, Weinstock JV. Trichuris suis seems to be safe and possibly effective in the treatment of inflammatory bowel disease. Am J Gastroenterol. 2003 Sep;98(9):2034-41. doi: 10.1111/j.1572-0241.2003.07660.x.
- Background: PubMed 15677912Moreels TG, Pelckmans PA. Gastrointestinal parasites: potential therapy for refractory inflammatory bowel diseases. Inflamm Bowel Dis. 2005 Feb;11(2):178-84. doi: 10.1097/00054725-200502000-00012.
- Background: PubMed 17499605Baumgart DC, Carding SR. Inflammatory bowel disease: cause and immunobiology. Lancet. 2007 May 12;369(9573):1627-40. doi: 10.1016/S0140-6736(07)60750-8.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
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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.
Stephen Hanauer, MD study chair
Northwestern University
Bana Jabri, MD, PhD study chair
University of Chicago
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trichuris suis ova (TSO) in people with Colitis, Ulcerative, run by National Institute of Allergy and Infectious Diseases (NIAID) at 17 sites 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 7 inclusion and 37 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: stopped early, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2017). 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?
Percentage of Participants Who Achieved a Clinical Response at Week 12 (time frame: Week 12). 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 NCT01953354, which also lists 3 linked publications.
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 17 Mar 2017.