Clinical Trial of Gut Microbiota in the Management of Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03033199
• Other study ID #: ITP-Microbiota
• Status: Recruiting
• Phase: Phase 2
• First received: January 16, 2017
• Last updated: January 24, 2017
• Start date: January 2017
• Est. completion date: August 2018

Study information

• Verified date: January 2017
• Source: Shandong University
• Contact: Ming Hou
• Email: houming[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

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.
• Dexamethasone
Dexamethasone 40 mg per day, 4 consecutive days

Locations

Country	Name	City	State
China	Shandong University Qilu hospital	Jinan	Shandong

Sponsors (6)

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

Country where clinical trial is conducted

China, 

References & Publications (4)

Kang Y, Cai Y, Zhang X, Kong X, Su J. Altered gut microbiota in RA: implications for treatment. Z Rheumatol. 2016 Dec 1. [Epub ahead of print] — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet count	R. A response (R) was defined as a sustained (= 3 months) platelet count = 30×10^9/L without recurrence of thrombocytopenia	From date of randomization until the date of first documented progression,up to 12 months