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Clinical Trial of Gut Microbiota in the Management of Immune Thrombocytopenia

Primary Purpose

Immune Thrombocytopenia

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Probiotic Agent

Dexamethasone

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Gut microbiota, Immune thrombocytopenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

Shandong University Qilu hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Probiotic Agent Combining HD-DXM

HD-DXM

Arm 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

Dexamethasone 40 mg per day, 4 consecutive days

Outcomes

Primary Outcome Measures

Platelet count

R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia

Secondary Outcome Measures

Full Information

NCT ID

NCT03033199

First Posted

January 16, 2017

Last Updated

January 24, 2017

Sponsor

Shandong University

Collaborators

Jinan Central Hospital, The Second Hospital of Shandong University, Qianfoshan Hospital, Qingdao University, Yantai Yuhuangding Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03033199

Brief Title

Clinical Trial of Gut Microbiota in the Management of Immune Thrombocytopenia

Official Title

A Multi-center Randomized Clinical Trial of Regulating Gut Microbiota by Probiotic Agents in Management of Immune Thrombocytopenia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (undefined)

Primary Completion Date

February 2018 (Anticipated)

Study Completion Date

August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

Collaborators

Jinan Central Hospital, The Second Hospital of Shandong University, Qianfoshan Hospital, Qingdao University, Yantai Yuhuangding Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune Thrombocytopenia

Keywords

Gut microbiota, Immune thrombocytopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Probiotic Agent Combining HD-DXM

Arm Type

Active Comparator

Arm Description

Arm Title

HD-DXM

Arm Type

Active Comparator

Arm Description

Dexamethasone 40 mg per day, 4 consecutive days

Intervention Type

Drug

Intervention Name(s)

Probiotic Agent

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone 40 mg per day, 4 consecutive days

Primary Outcome Measure Information:

Title

Platelet count

Description

R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia

Time Frame

From date of randomization until the date of first documented progression,up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Hou

houming@medmail.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Hou

Organizational Affiliation

Qilu Hospital, Shandong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shandong University Qilu hospital

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Hou

houming@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Ming Hou

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27909795

Citation

Kang Y, Cai Y, Zhang X, Kong X, Su J. Altered gut microbiota in RA: implications for treatment. Z Rheumatol. 2017 Jun;76(5):451-457. doi: 10.1007/s00393-016-0237-5.

Results Reference

background

PubMed Identifier

24355439

Citation

Vaghef-Mehrabany E, Alipour B, Homayouni-Rad A, Sharif SK, Asghari-Jafarabadi M, Zavvari S. Probiotic supplementation improves inflammatory status in patients with rheumatoid arthritis. Nutrition. 2014 Apr;30(4):430-5. doi: 10.1016/j.nut.2013.09.007. Epub 2013 Dec 17.

Results Reference

background

PubMed Identifier

24018052

Citation

Smits LP, Bouter KE, de Vos WM, Borody TJ, Nieuwdorp M. Therapeutic potential of fecal microbiota transplantation. Gastroenterology. 2013 Nov;145(5):946-53. doi: 10.1053/j.gastro.2013.08.058. Epub 2013 Sep 7.

Results Reference

background

PubMed Identifier

27135916

Citation

Zamani B, Golkar HR, Farshbaf S, Emadi-Baygi M, Tajabadi-Ebrahimi M, Jafari P, Akhavan R, Taghizadeh M, Memarzadeh MR, Asemi Z. Clinical and metabolic response to probiotic supplementation in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled trial. Int J Rheum Dis. 2016 Sep;19(9):869-79. doi: 10.1111/1756-185X.12888. Epub 2016 May 2.

Results Reference

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Clinical Trial of Gut Microbiota in the Management of Immune Thrombocytopenia

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