The Yale-Griffin Prevention Research Center, the Multiple Sclerosis Treatment Center at Griffin Hospital, and Yale University are teaming up see if changing the bacteria in a person’s intestines can be an effective, safe and tolerable strategy to slow the inflammatory process involved in multiple sclerosis (MS).
MS is an auto-immune disease that affects the central nervous system. Some studies have found that an imbalance of intestinal bacteria can lead to inflammation in the immune system. This pilot investigational study at Griffin Hospital will involve providing oral capsules with fecal material from healthy donors in the hope that it will lead to favorable changes in the intestinal bacteria – or microbiome - of people with MS, which in turn might slow the inflammatory process involved in the progression of MS.
The study team, led by neurologist Joseph Guarnaccia, MD, of the Multiple Sclerosis Treatment Center at Griffin Hospital, will provide 30 oral capsules with this fecal material to patients with MS, and monitor these patients before and afterward to learn what effects the capsules might have.
The study team is recruiting people with MS who are 18 - 40 years old, can walk with or without assistance, and are not on immunotherapy except for interferon beta or glatiramer acetate. They must be able to visit Griffin Hospital eight times over a four-month period. The visits will include a clinical screening, one visit to swallow 30 capsules on an empty stomach, and five other visits for physical exams, blood and stool samples, and surveys.
Those who complete the study will receive $800, payable in installments. The capsules, procedures, and tests will be provided free of charge. The State of Connecticut Department of Public Health is providing funding for this study.
To learn more about this study, contact Dr. Guarnaccia, MD, at 203-732-1290 or email@example.com.