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Clinical Trial of Gut Microbiota in the Management of Immune Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT03033199
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : January 26, 2017
Sponsor:
Collaborators:
Jinan Central Hospital
The Second Hospital of Shandong University
Qianfoshan Hospital
Qingdao University
Yantai Yuhuangding Hospital
Information provided by (Responsible Party):
Ming Hou, Shandong University

Brief 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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Probiotic Agent Drug: Dexamethasone Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multi-center Randomized Clinical Trial of Regulating Gut Microbiota by Probiotic Agents in Management of Immune Thrombocytopenia
Study Start Date : January 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : August 2018


Arm Intervention/treatment
Active Comparator: Probiotic Agent Combining HD-DXM

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

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

Active Comparator: HD-DXM
Dexamethasone 40 mg per day, 4 consecutive days
Drug: Dexamethasone
Dexamethasone 40 mg per day, 4 consecutive days




Primary Outcome Measures :
  1. Platelet count [ Time Frame: From date of randomization until the date of first documented progression,up to 12 months ]
    R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033199


Contacts
Contact: Ming Hou houming@medmail.com.cn

Locations
China, Shandong
Shandong University Qilu hospital Recruiting
Jinan, Shandong, China, 250012
Contact: Ming Hou       houming@medmail.com.cn   
Principal Investigator: Ming Hou         
Sponsors and Collaborators
Shandong University
Jinan Central Hospital
The Second Hospital of Shandong University
Qianfoshan Hospital
Qingdao University
Yantai Yuhuangding Hospital
Investigators
Principal Investigator: Ming Hou Qilu hospital, Shandong University

Publications:
Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT03033199     History of Changes
Other Study ID Numbers: ITP-Microbiota
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ming Hou, Shandong University:
Gut microbiota
Immune thrombocytopenia

Additional relevant MeSH terms:
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors