Colitis, Ulcerative Clinical Trial
Official title:
A Prospective, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study of Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis and Its Effects on Mucosal Immune State and Microbiota
The purpose of this study is to evaluate the safety and effectiveness of trichuris suis ova (TSO) in ulcerative colitis (UC). We will look at how TSO affects the body's immune response and if there are related changes in participants' UC.
The cause of UC, an inflammatory bowel disease (IBD), is not well understood. It is believed
to be caused from an abnormal immune response to the normal bacteria that live in the gut
(intestines and colon). This response acts as an "attack" on the healthy tissue of the bowel
by a person's own immune cells which leads to disease.
It is well known that autoimmune diseases such as IBD, asthma, diabetes, and multiple
sclerosis are more common in industrialized, well-developed countries with better sanitation
and hygiene, as in the United States. These "cleaner" environments reduce exposure to germs
and parasites naturally found in the environment. This reduced exposure may trigger
responses in the body that make people more prone to diseases such as UC. People in
non-industrialized countries and the tropics, where parasites are common, rarely develop
these diseases. This observation has led researchers to want to better understand the
relationship between the lack of natural bacteria in the gut and the onset of autoimmune
diseases like as UC.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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