Safety and efficacy of helminth treatment in relapsing-remitting multiple sclerosis: Results of the HINT 2 clinical trial.
Mult Scler
; 25(1): 81-91, 2019 01.
Article
in En
| MEDLINE
| ID: mdl-29064315
ABSTRACT
BACKGROUND:
The hygiene hypothesis suggests that microbial replacement may be therapeutic in allergic and autoimmune diseases. Nevertheless, the results of helminth treatment, including in multiple sclerosis (MS), have been inconclusive.OBJECTIVE:
To assess safety and brain magnetic resonance imaging (MRI) activity in subjects with relapsing-remitting multiple sclerosis (RRMS) during oral administration of ova from the porcine whipworm, Trichuris suis (TSO).METHODS:
A total of 16 disease-modifying treatment (DMT) naive RRMS subjects were studied in a baseline versus treatment (BVT) controlled prospective study. MRI scans were performed during 5 months of screening-observation, 10 months of treatment, and 4 months of post-treatment surveillance.RESULTS:
No serious symptoms or adverse events occurred during treatment. For the cohort, there was a trend consistent with a 35% diminution in active lesions when observation MRIs were compared to treatment MRIs ( p = 0.08), and at the level of individuals, 12 of 16 subjects improved during TSO treatment. T regulatory lymphocytes were increased during TSO treatment.CONCLUSION:
TSO is safe in RRMS subjects. Potentially favorable MRI outcomes and immunoregulatory changes were observed during TSO treatment; however, the magnitude of these effects was modest, and there was considerable variation among the responses of individual subjects.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Trichuris
/
Outcome Assessment, Health Care
/
Multiple Sclerosis, Relapsing-Remitting
/
Helminthiasis
/
Immunotherapy
Type of study:
Clinical_trials
/
Observational_studies
Limits:
Adult
/
Animals
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Mult Scler
Journal subject:
NEUROLOGIA
Year:
2019
Document type:
Article
Affiliation country:
United States