Clinical Trial of Gut Microbiota in the Management of Immune Thrombocytopenia

NCT ID: NCT03033199

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-08-31

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.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Probiotic Agent

Intervention Type: DRUG

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

Intervention Type: DRUG

Dexamethasone 40 mg per day, 4 consecutive days

HD-DXM

Dexamethasone 40 mg per day, 4 consecutive days

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Dexamethasone 40 mg per day, 4 consecutive days

Interventions

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.

Intervention Type: DRUG

Dexamethasone

Dexamethasone 40 mg per day, 4 consecutive days

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinan Central Hospital

OTHER

Sponsor Role: collaborator

The Second Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Qianfoshan Hospital

OTHER

Sponsor Role: collaborator

Qingdao University

OTHER

Sponsor Role: collaborator

Yantai Yuhuangding Hospital

OTHER

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Ming Hou

Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Hou

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

Shandong University Qilu hospital

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Hou

Role: CONTACT

houming@medmail.com.cn

Facility Contacts

Ming Hou

Role: primary

houming@medmail.com.cn

References

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.

Reference Type: BACKGROUND

PMID: 27909795 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24355439 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24018052 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27135916 (View on PubMed)

Other Identifiers

ITP-Microbiota

Identifier Type: -

Identifier Source: org_study_id