Worms for Immune Regulation of Multiple Sclerosis (WIRMS)
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ClinicalTrials.gov Identifier: NCT01470521 |
Recruitment Status :
Completed
First Posted : November 11, 2011
Last Update Posted : January 29, 2016
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Sponsor:
University of Nottingham
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
University of Nottingham
Tracking Information | ||||
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First Submitted Date ICMJE | November 9, 2011 | |||
First Posted Date ICMJE | November 11, 2011 | |||
Last Update Posted Date | January 29, 2016 | |||
Study Start Date ICMJE | December 2011 | |||
Actual Primary Completion Date | January 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
The cumulative number of new or enlarging Gd+ lesions at month 9 [ Time Frame: Month 9 ] | |||
Original Primary Outcome Measures ICMJE |
The cumulative number if new or enlarging Gd+ lesions at month 9 [ Time Frame: Month 9 ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Worms for Immune Regulation of Multiple Sclerosis | |||
Official Title ICMJE | Worms for Immune Regulation of Multiple Sclerosis (WIRMS) | |||
Brief Summary | The purpose of this study is to determine whether people with MS who are exposed to a small number of hookworms will have less inflammation and less MS disease activity. | |||
Detailed Description | There is evidence that certain parasitic infections may protect against autoimmune or inflammatory diseases, including multiple sclerosis (MS), asthma and type1 diabetes. The 'hygiene hypothesis' postulates exposure to infectious agents confers protection against these disorders. One putative mechanism depends on the activity of regulatory T cells (Treg), naturally occurring or induced cells that prevent excessive immune activation and autoimmunity. Reports in the last 5 years lend credence to the hygiene hypothesis in MS: epidemiological investigations show an inverse relationship to infections with the nematode Trichuris, and a study with serial clinical, immunological and MRI follow-up shows MS patients developing intestinal parasitoses have much milder disease course compared with uninfected matched MS controls followed over 5 years. A role for Treg and also a novel population of B regulatory (Breg) cells is suggested in this study. The University of Nottingham has extensive experience with human parasite research and have completed essential safety studies of controlled infection with hookworm in normal volunteers and people with atopy. Asthma and Crohn's disease studies are underway and show an immunological effect even with 10 larvae. This is the first controlled parasite exposure study in patients with relapsing MS with in 36 patients 25 hookworm larvae vs 36 patients with placebo. Patients will be followed clinically (relapse rate, disability scores), immunologically and radiologically (serial MRI scans with Gadolinium) for 1 year. The cumulative number of new and active lesions on T2 weighted MRI will be the primary outcome measure. Regulatory network induction (Treg induction, Breg/Tr1 and NK) will be the immunological secondary outcome measure. Relapse rate will be secondary clinical outcome measure. A number of clinical, MRI and immune parameters will be exploratory measures. Cytokine profiles, eosinophil and egg counts, IgE and IgG subsets and IgE/IgG4 ratios will be measured, to relate altered immune responses to disease modulation. Immune responses will be assessed to neuroantigen and to mitogen, and parasite antigens (excretory/secretory products). This study will be an essential early step in assessing the potential for therapeutic immunomodulation with parasites in MS. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Multiple Sclerosis, Relapsing-Remitting | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Tanasescu R, Tench CR, Constantinescu CS, Telford G, Singh S, Frakich N, Onion D, Auer DP, Gran B, Evangelou N, Falah Y, Ranshaw C, Cantacessi C, Jenkins TP, Pritchard DI. Hookworm Treatment for Relapsing Multiple Sclerosis: A Randomized Double-Blinded Placebo-Controlled Trial. JAMA Neurol. 2020 Sep 1;77(9):1089-1098. doi: 10.1001/jamaneurol.2020.1118. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
72 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2016 | |||
Actual Primary Completion Date | January 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: No populations at risk of severe illness or death will be included in this study
Previous treatment
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01470521 | |||
Other Study ID Numbers ICMJE | 08126 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | University of Nottingham | |||
Study Sponsor ICMJE | University of Nottingham | |||
Collaborators ICMJE | National Multiple Sclerosis Society | |||
Investigators ICMJE |
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PRS Account | University of Nottingham | |||
Verification Date | January 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |