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Trial record 13 of 91 for:    Recruiting Studies | fecal microbiota transplantation

Fecal Microbiota Transplantation for Refractory IgA Nephropathy

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ClinicalTrials.gov Identifier: NCT03633864
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Shiren sun, Fourth Military Medical University

Brief Summary:
IgA nephropathy (IgAN) is one of the most common glomerular diseases worldwide. Current treatments for IgAN are limited by their relatively insufficient efficacy and severe adverse events. Previous studies suggested that the disorder of intestinal flora may play an important role in the pathogenesis and prognosis of IgAN. Fecal microbiota transplantation (FMT) have been proved to be effective on rebuilding the intestinal microecological balance. However, there is no evidence for the safety and efficacy of FMT in IgAN. Therefore, investigators perform a prospective cohort study to evaluate the safety and efficacy of FMT in IgAN patients who did not response to the conventional treatment and did not want to aggravate immunosuppressive treatments or IgAN patients who did not response to immunosuppressive treatments.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Biological: Fecal microbiota transplantation Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiota Transplantation for Refractory IgA Nephropathy: a Prospective, Single-center, Cohort Study
Actual Study Start Date : November 22, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FMT treatment
FMT treatment arm: Accept fecal microbiota transplantation without changing the ongoing treatment strategy.
Biological: Fecal microbiota transplantation
Fecal donors are selected according to the predefined criteria. Fecal microbiota suspension is prepared by using fresh feces from the selected fecal donors. Then, administration of 200 ml fecal microbiota suspension through a transendoscopic enteral tubing or retention enema.




Primary Outcome Measures :
  1. Change of Urinary protein [ Time Frame: one time per week up to 8 weeks ]
    24 hours urinary protein quantity


Secondary Outcome Measures :
  1. Change of Serum creatinine [ Time Frame: one time per week up to 8 weeks ]
    Concentration of serum creatinine

  2. Change of eGFR [ Time Frame: one time per week up to 8 weeks ]
    eGFR

  3. Change of Hematuria [ Time Frame: one time per week up to 8 weeks ]
    Hematuria

  4. Change of Blood pressure [ Time Frame: one time per week up to 8 weeks ]
    Blood pressure

  5. Change of Serum IgA1 [ Time Frame: one time per week up to 8 weeks ]
    Serum IgA1

  6. Change of Fecal microbiota [ Time Frame: one time per week up to 8 weeks ]
    Fecal microbiota

  7. Adverse events associated with FMT [ Time Frame: one time per week up to 8 weeks ]
    Adverse events associated with FMT



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult, age: 18-65 years old.
  • Pathological diagnosis with IgAN, eGFR:20-120 mL/min/1.73 m2.
  • The 24-hour urinary protein was still greater than 1g after 3-6 months of treatment of ACEI/ARB
  • Recurrence of IgAN after glucocorticoid and (or)immunosuppressant decrement and the 24-hour urinary protein was greater than 1g.
  • Not suitable for the administration of glucocorticoid and (or) immunosuppressive agents because of side effects.
  • Women of child-bearing age with negative urine pregnancy test have no pregnancy plan for the next 18 months and take effective contraceptive measures.
  • Agree to participate in this clinical trial

Exclusion Criteria:

  • Malignant tumors and other diseases with expected survival time <3 months.
  • Severe cardiovascular and cerebrovascular diseases and pulmonary dysfunction.
  • Other immune system diseases.
  • Diabetes
  • Inflammatory bowel disease(IBD)
  • Clostridium difficile infection
  • Gastrointestinal tumor
  • Active gastrointestinal bleeding
  • Acute and chronic gastroenteritis
  • Have received or are receiving FMT treatment.
  • HIV
  • Psychosis AND dysgnosia
  • Contraindication of colonoscopy and enema
  • Alcohol/drug abuse
  • Other conditions that the researchers thought were not appropriate for the group.

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): NCT03633864


Contacts
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Contact: Shiren Sun, M.D. +8602984775193 sunshiren@medmail.com.cn
Contact: Ming Bai, M.D +8602984775193 mingbai1983@126.com

Locations
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China, Shaanxi
Xijing Hospital of Nephrology Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Shiren Sun, M.D.    +8602984775193    sunshiren@medmail.com.cn   
Contact: Ming Bai, M.D.    +8602984775193    mingbai1983@126.com   
Principal Investigator: Shiren Sun, M.D.         
Sponsors and Collaborators
Fourth Military Medical University
Investigators
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Principal Investigator: Shiren Sun, M.D. Xijing Hospital, the Fourth Military Medical University

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Responsible Party: Shiren sun, MD, Professor, Fourth Military Medical University
ClinicalTrials.gov Identifier: NCT03633864     History of Changes
Other Study ID Numbers: FMT for IgAN
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Shiren sun, Fourth Military Medical University:
IgA nephropathy
fecal microbiota transplantation

Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases