Clinical Trial of Gut Microbiota in the Management of Immune Thrombocytopenia
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Platelet count [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
Eligibility Criteria
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
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patients with systemic lupus erythematosus and/or antiphospholipid syndrome
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patients with known gastro-intestinal bleeding.
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use of antibiotics, prebiotics or probiotics in the past 4 weeks;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shandong University Qilu hospital | Jinan | Shandong | China | 250012 |
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
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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. Review.
- 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.
- 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.
- ITP-Microbiota