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Clinical Trial of Gut Microbiota in the Management of Immune Thrombocytopenia

NCT03033199 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-01-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Probiotic Agent

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.

DRUG

Dexamethasone

Dexamethasone 40 mg per day, 4 consecutive days

Sponsors & Collaborators

  • Jinan Central Hospital

    collaborator OTHER

  • The Second Hospital of Shandong University

    collaborator OTHER

  • Qianfoshan Hospital

    collaborator OTHER

  • Qingdao University

    collaborator OTHER

  • Yantai Yuhuangding Hospital

    collaborator OTHER

  • Shandong University

    lead OTHER

Principal Investigators

  • Ming Hou · Qilu Hospital, Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-02-28
Completion
2018-08-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03033199 on ClinicalTrials.gov