drugset / Trial / NCT03033199

Clinical Trial of Gut Microbiota in the Management of Immune Thrombocytopenia

NCT03033199

RandomizedParallel-groupSingle-blindTreatment

Summary

Primary immune thrombocytopenia (ITP) is an acquired autoimmune bleeding disorder, accounting for about 1/3 of clinical hemorrhagic diseases. Loss of immune tolerance leading to increased platelet destruction and decreased platelet production is the main pathogenesis of ITP. Dysbiosis of the gut microbiota was found in many autoimmune diseases like rheumatic arthritis(RA),inflammatory bowel disease(IBD),multiple sclerosis and probiotic treatment or fecal microbiota transplantation(FMT) which can regulate the gut microbiota has good clinical efficacy in those disorders. One ITP patient with ulcerative colitis(UC) was treated with FMT and got progressive but significant increase in platelet level and lasted for several years.

Timeline

Start
2017-01
Primary completion
2018-02
Completion
2018-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Bifidobacterium bifidum Unknown Oral
Subject Lactobacillus acidophilus Other / unclassified Oral
Subject Lactobacillus casei Unknown Oral
Comparator Dexamethasone Small molecule 40 mg