Clinical Trial of Gut Microbiota in the Management of Immune Thrombocytopenia

Shandong University

Status and phase: Unknown; Phase 2

Conditions: Immune Thrombocytopenia

Treatments: Drug: Probiotic Agent; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03033199

ITP-Microbiota

Details and patient eligibility

About

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.

Full description

The investigators are undertaking a multicenter, single-arm study of 60 primary ITP adult patients from 5 medical centers in China. All the participants are randomly divided into two groups to orally intake either probiotic supplements (n = 30) or placebo (n = 30) for 4 weeks in addition with high dose dexamethasone(40 mg/d for 4 days). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• need of treatment(s) (including, but not limited to, low dose of corticosteroids) to minimize the risk of clinically significant bleeding. Need of on-demand or adjunctive therapy alone does not qualify the patient as refractory
• primary ITP confirmed by excluding other supervened causes of thrombocytopenia

Exclusion criteria

• pregnancy
• hypertension
• cardiovascular disease
• diabetes
• liver and kidney function impairment
• HCV, HIV, HBsAg seropositive status
• patients with systemic lupus erythematosus and/or antiphospholipid syndrome
• patients with known gastro-intestinal bleeding.
• use of antibiotics, prebiotics or probiotics in the past 4 weeks;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Probiotic Agent Combining HD-DXM

Active Comparator group

Description:

probiotic capsules containing three viable and freezedried strains-Lactobacillus acidophilus,Lactobacillus casei, and Bifidobacterium bifidum：2 capsules, bid x 4 weeks for one cycle. It will be given for one or two cycles. Dexamethasone 40mg per day, 4 consecutive day

Treatment:

Drug: Dexamethasone

Drug: Probiotic Agent

HD-DXM

Active Comparator group

Description:

Dexamethasone 40 mg per day, 4 consecutive days

Treatment:

Drug: Dexamethasone