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Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT04124211
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Collaborator:
Southern Medical University, China
Information provided by (Responsible Party):
Jie Shen, The Third Affiliated Hospital of Southern Medical University

Brief Summary:
This study intends to reconstruct intestinal micro-ecology through fecal Microbiome transplantation (FMT) technology, to treat patients with type 1 diabetes, and combine intestinal Metagenomics and 16s rRNA sequencing technology to study the relevant mechanism of intestinal micro-ecology for the treatment of type 1 diabetes.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Biological: Fecal Microbiota Transplantation (FMT) Not Applicable

Detailed Description:
Type 1 diabetes is an organ-specific autoimmune disease based on islet beta cell-specific destruction and absolute insulin deficiency. Studies on the pathogenesis of intestinal flora and type 1 diabetes have shown that as an "endocrine organ", intestinal microbes play an important role in regulating the secretion of the body. Bacteria in the intestine can not only directly synthesize hormones or hormone-like compounds, but also regulate the synthesis and secretion of corresponding hormones in the widely distributed intestinal endocrine cells, thereby participating in the regulation of various biological functions in the human body. This study uses fecal microbiome transplantation (FMT) to explore another potential treatment for type 1 diabetes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes
Actual Study Start Date : August 25, 2019
Estimated Primary Completion Date : March 10, 2020
Estimated Study Completion Date : March 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FMT Arm
10 Participants will be enrolled in this arm to receive FMT treatment
Biological: Fecal Microbiota Transplantation (FMT)
FMT will be performed through transendoscopic enteral tubing (TET) within one week during treatment period




Primary Outcome Measures :
  1. Changes in mean amplitude of glycemic excursion (MAGE) [ Time Frame: 24 Weeks ]
    Dates from Continuous glucose monitoring system

  2. Changes in standard deviation of blood glucose (SDBG) [ Time Frame: 24 Weeks ]
    Dates from Continuous glucose monitoring system

  3. Changes in hemoglobin A1c (HbA1c) [ Time Frame: 24 Weeks ]
    Dates from blood chemistry test

  4. Safety of FMT [ Time Frame: 24 Weeks ]
    Number of all participants with treatment-related adverse events as assessed by CTCAE v4.03


Secondary Outcome Measures :
  1. Changes in 24h mean blood glucose(MBG) [ Time Frame: 24 Weeks ]
    Dates from Continuous glucose monitoring system

  2. Changes in percentage of time of blood glucose(PT) [ Time Frame: 24 Weeks ]
    Dates from Continuous glucose monitoring system

  3. Changes in mean absolute glucose(MAG) [ Time Frame: 24 Weeks ]
    Dates from Continuous glucose monitoring system

  4. Changes in standard deviation of blood glucose(SDBG) [ Time Frame: 24 Weeks ]
    Dates from Continuous glucose monitoring system

  5. Changes in coefficient of variation(CV) [ Time Frame: 24 Weeks ]
    Dates from Continuous glucose monitoring system

  6. Changes in high blood glucose index(HBGI) [ Time Frame: 24 Weeks ]
    Dates from Continuous glucose monitoring system

  7. Changes in low blood glucose index(LBGI) [ Time Frame: 24 Weeks ]
    Dates from Continuous glucose monitoring system

  8. Changes in effective blood glucose fluctuations in frequency(NGE) [ Time Frame: 24 Weeks ]
    Dates from Continuous glucose monitoring system

  9. Changes in glycated albumin (GA) [ Time Frame: 24 Weeks ]
    Dates from blood chemistry test

  10. Changes of serum C-peptide (fasting, 30min after meal, 120min after meal) [ Time Frame: 24 Weeks ]
    Dates from blood chemistry test

  11. Assessment of diabetes antibodies [ Time Frame: 24 Weeks ]
    Assessment of diabetes antibodies including Islet Cell Cytoplasmic Autoantibodies (ICA), Insulin Autoantibodies (IAA), Glutamic Acid Decarboxylase Autoantibodies (GADA), Insulinoma-Associated-2 Autoantibodies (IA-2A), and Zinc Transporter-8 Autoantibodies (ZnT8A);

  12. Changes in intestinal microbiome profile [ Time Frame: 24 Weeks ]
    Changes in intestinal microbiome profile by 16s rRNA sequencing and metagenomics.

  13. Changes in Peripheral Blood Stem Cell (PBMC) [ Time Frame: 24 Weeks ]
    Dates from blood test

  14. Changes in body weight to calculate body mass index (BMI) [ Time Frame: 24 Weeks ]
    Dates from physical examination

  15. Pathological changes of intestinal mucosa [ Time Frame: 24 Weeks ]
    Changes in intestinal mucosa profile by enteroscopy

  16. Changes in blood pressure [ Time Frame: 24 Weeks ]
    Dates from physical examination

  17. Changes in oral mucosal bacteria colonization [ Time Frame: 24 Weeks ]
    Changes in oral mucosal bacteria by 16s rRNA sequencing and metagenomics.

  18. Changes in urine microalbumin [ Time Frame: 24 Weeks ]
    Dates from urine test

  19. Blood chemistry panel [ Time Frame: 24 Weeks ]
    Changes in the results of blood chemistry tests including complete blood count, diabetic autoantibodies, serum C peptide, insulin, blood glucose, routine urine, urinary microalbumin, routine stool, liver function, renal function, seven ions, myocardial enzymes, six glycolipids, glycated hemoglobin and glycosylated serum albumin before and after treatment.



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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:

  • (1) Type 1 diabetes patients.
  • (2) Age between 18 and 65 years old, regardless of gender.
  • (3) No serious comorbidities.
  • (4) Accept and suitable for endoscopic catheterization (TET) and fecal transplantation (FMT).
  • (5) Can receive follow-up and follow-up examinations on time. (6) Subjects need to sign an informed consent form.

Exclusion Criteria:

  • (1) Systematic application of glucocorticoids, other immunosuppressive drugs or biological immune modulators, antibiotics, probiotics, and other microecological agents to alter intestinal motility within 6 months prior to enrollment.
  • (2) An infection that is active.
  • (3) Combined with irritable bowel syndrome, inflammatory bowel disease, celiac disease, and other chronic gastrointestinal diseases, the condition has not been controlled.
  • (4) Chronic diseases such as cerebrovascular disease, cardiovascular disease, and diabetic autonomic neuropathy.
  • (5) Pregnancy or with a pregnancy plan
  • (6) severe organ dysfunction (including decompensated cirrhosis, malignant tumors, etc.)

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): NCT04124211


Contacts
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Contact: Daoyan Pan, MD 0086-02062784353 pdy4266@126.com

Locations
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China, Guangdong
The third affiliated hospital of Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Daoyan Pan, MD    0086-02062784353    pdy4266@126.com   
Principal Investigator: Jie Shen, MD         
Principal Investigator: Ye Chen, MD         
Sponsors and Collaborators
The Third Affiliated Hospital of Southern Medical University
Southern Medical University, China
Investigators
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Principal Investigator: Jie Shen, MD The Third Affiliated Hospital of Southern Medical University

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Responsible Party: Jie Shen, MD, Director of Endocrinology, The Third Affiliated Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT04124211     History of Changes
Other Study ID Numbers: NYSY-NFM
2018-lunshen-017 ( Other Identifier: No.3 Affiliated Hospital of SMU )
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Jie Shen, The Third Affiliated Hospital of Southern Medical University:
Fecal Microbiome Transplantation (FMT)
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases