2 These agents induce Tregs, which prevent autoimmunity.
1 The hygiene hypothesis postulates that certain infectious agents, including gastrointestinal helminths, protect against inflammatory diseases, including MS. Multiple sclerosis is unevenly distributed across populations. It is associated with an imbalance between inflammatory (eg, proinflammatory cytokines) and immunoregulatory factors (eg, anti-inflammatory cytokines and regulatory T cells ). Multiple sclerosis (MS) is an immune-mediated central nervous system disease characterized clinically by neurological deficits with relapsing-remitting and progressive patterns and pathologically by inflammation, demyelination, and loss and damage to neurons.
#Number of hookworms in humans registration
Trial Registration Identifier: NCT01470521 It appears that a living organism can precipitate immunoregulatory changes that may affect MS disease activity. Hookworm infection increased T regulatory cells, suggesting an immunobiological effect of hookworm. The primary outcome did not reach significance, likely because of a low level of disease activity. There were 5 relapses (14.3%) in the hookworm group vs 11 (30.6%) receiving placebo.Ĭonclusions and Relevance Treatment with hookworm was safe and well tolerated.
#Number of hookworms in humans skin
There were no differences in adverse events between groups except more application-site skin discomfort in the hookworm group (82% vs 28%). No patients withdrew because of adverse effects.
The percentage of CD4+CD25 highCD127 negT cells increased at month 9 in the hookworm group (hookworm, 32 placebo, 34 P = .01). The median cumulative numbers of new/enlarging/enhancing lesions were not significantly different between the groups by preplanned Mann-Whitney U tests, which lose power with tied data (high number of zeroactivity MRIs in the hookworm group, 18/35 vs 10/36 in the placebo group). Sixty-six patients (93.0%) completed the trial. Results Patients (mean age, 45 years 50 women ) were randomized to receive hookworm (35 ) or placebo (36 ). The secondary end point was the percentage of cluster of differentiation (CD) 4+CD25 highCD127 negT regulatory cells in peripheral blood. Main Outcomes and Measures The primary end point was the cumulative number of new/enlarging T2/new enhancing T1 lesions at month 9. The MRI scans were performed monthly during months 3 to 9 and 3 months posttreatment.
Interventions Patients were randomized (1:1) to receive either 25 Necator americanus larvae transcutaneously or placebo. Seventy-three patients were screened of these, 71 were recruited (2 ineligible/declined). Patients aged 18 to 61 years with relapsing MS without disease-modifying treatment were recruited from the MS clinic. Objective To determine whether hookworm treatment has effects on magnetic resonance imaging (MRI) activity and T regulatory cells in relapsing MS.ĭesign, Setting, and Participants This 9-month double-blind, randomized, placebo-controlled trial was conducted between September 2012 and March 2016 in a modified intention-to-treat population (the data were analyzed June 2018) at the University of Nottingham, Queen’s Medical Centre, a single tertiary referral center. To our knowledge, there are no controlled treatment trials with helminth in MS. Importance Studies suggest gut worms induce immune responses that can protect against multiple sclerosis (MS).
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