BACKGROUND: Probiotic treatment strategy based on the hygiene hypothesis, such as administration of ova from the non-pathogenic helminth, Trichuris suis, (TSO) has proven safe and effective in autoimmune inflammatory bowel disease. OBJECTIVE: To study the safety and effects of TSO in a second autoimmune disease, multiple sclerosis (MS), we conducted the phase 1 Helminth-induced Immunomodulatory Therapy (HINT 1) study. METHODS: Five subjects with newly diagnosed, treatment-naive relapsing-remitting multiple sclerosis (RRMS) were given 2500 TSO orally every 2 weeks for 3 months in a baseline versus treatment control exploratory trial. RESULTS: The mean number of new gadolinium-enhancing magnetic resonance imaging (MRI) lesions (n-Gd+) fell from 6.6 at baseline to 2.0 at the end of TSO administration, and 2 months after TSO was discontinued, the mean number of n-Gd+ rose to 5.8. No significant adverse effects were observed. In preliminary immunological investigations, increases in the serum level of the cytokines IL-4 and IL-10 were noted in four of the five subjects. CONCLUSION: TSO was well tolerated in the first human study of this novel probiotic in RRMS, and favorable trends were observed in exploratory MRI and immunological assessments. Further investigations will be required to fully explore the safety, effects, and mechanism of action of this immunomodulatory treatment.
BACKGROUND: Probiotic treatment strategy based on the hygiene hypothesis, such as administration of ova from the non-pathogenic helminth, Trichuris suis, (TSO) has proven safe and effective in autoimmune inflammatory bowel disease. OBJECTIVE: To study the safety and effects of TSO in a second autoimmune disease, multiple sclerosis (MS), we conducted the phase 1 Helminth-induced Immunomodulatory Therapy (HINT 1) study. METHODS: Five subjects with newly diagnosed, treatment-naive relapsing-remitting multiple sclerosis (RRMS) were given 2500 TSO orally every 2 weeks for 3 months in a baseline versus treatment control exploratory trial. RESULTS: The mean number of new gadolinium-enhancing magnetic resonance imaging (MRI) lesions (n-Gd+) fell from 6.6 at baseline to 2.0 at the end of TSO administration, and 2 months after TSO was discontinued, the mean number of n-Gd+ rose to 5.8. No significant adverse effects were observed. In preliminary immunological investigations, increases in the serum level of the cytokines IL-4 and IL-10 were noted in four of the five subjects. CONCLUSION:TSO was well tolerated in the first human study of this novel probiotic in RRMS, and favorable trends were observed in exploratory MRI and immunological assessments. Further investigations will be required to fully explore the safety, effects, and mechanism of action of this immunomodulatory treatment.
Authors: Rick M Maizels; Adam Balic; Natalia Gomez-Escobar; Meera Nair; Matt D Taylor; Judith E Allen Journal: Immunol Rev Date: 2004-10 Impact factor: 12.988
Authors: J Büning; N Homann; D von Smolinski; F Borcherding; F Noack; M Stolte; M Kohl; H Lehnert; D Ludwig Journal: Gut Date: 2008-08 Impact factor: 23.059
Authors: G L Mancardi; F Sardanelli; R C Parodi; E Melani; E Capello; M Inglese; A Ferrari; M P Sormani; C Ottonello; F Levrero; A Uccelli; P Bruzzi Journal: Neurology Date: 1998-04 Impact factor: 9.910
Authors: Nermina Vejzagić; Stig Milan Thamsborg; Helene Kringel; Allan Roepstorff; Johan Musaeus Bruun; Christian M O Kapel Journal: Parasitol Res Date: 2015-05-27 Impact factor: 2.289
Authors: Peter Vogel; Laura Janke; David M Gravano; Meifen Lu; Deepali V Sawant; Dorothy Bush; E Shuyu; Dario A A Vignali; Asha Pillai; Jerold E Rehg Journal: Vet Pathol Date: 2017-05-11 Impact factor: 2.221
Authors: Keren E Dolan; Heather J Finley; Cathleen M Burns; Margaret G Gasta; Crystal M Gossard; Emily C Parker; Jessica M Pizano; Christy B Williamson; Elizabeth A Lipski Journal: Integr Med (Encinitas) Date: 2016-10