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Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation (FMT)
Sponsored by
The Third Affiliated Hospital of Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Fecal Microbiome Transplantation (FMT)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • The third affiliated hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FMT Arm

Arm Description

10 Participants will be enrolled in this arm to receive FMT treatment

Outcomes

Primary Outcome Measures

Changes in mean amplitude of glycemic excursion (MAGE)
Dates from Continuous glucose monitoring system
Changes in standard deviation of blood glucose (SDBG)
Dates from Continuous glucose monitoring system
Changes in hemoglobin A1c (HbA1c)
Dates from blood chemistry test
Safety of FMT
Number of all participants with treatment-related adverse events as assessed by CTCAE v4.03

Secondary Outcome Measures

Changes in 24h mean blood glucose(MBG)
Dates from Continuous glucose monitoring system
Changes in percentage of time of blood glucose(PT)
Dates from Continuous glucose monitoring system
Changes in mean absolute glucose(MAG)
Dates from Continuous glucose monitoring system
Changes in standard deviation of blood glucose(SDBG)
Dates from Continuous glucose monitoring system
Changes in coefficient of variation(CV)
Dates from Continuous glucose monitoring system
Changes in high blood glucose index(HBGI)
Dates from Continuous glucose monitoring system
Changes in low blood glucose index(LBGI)
Dates from Continuous glucose monitoring system
Changes in effective blood glucose fluctuations in frequency(NGE)
Dates from Continuous glucose monitoring system
Changes in glycated albumin (GA)
Dates from blood chemistry test
Changes of serum C-peptide (fasting, 30min after meal, 120min after meal)
Dates from blood chemistry test
Assessment of diabetes antibodies
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);
Changes in intestinal microbiome profile
Changes in intestinal microbiome profile by 16s rRNA sequencing and metagenomics.
Changes in Peripheral Blood Stem Cell (PBMC)
Dates from blood test
Changes in body weight to calculate body mass index (BMI)
Dates from physical examination
Pathological changes of intestinal mucosa
Changes in intestinal mucosa profile by enteroscopy
Changes in blood pressure
Dates from physical examination
Changes in oral mucosal bacteria colonization
Changes in oral mucosal bacteria by 16s rRNA sequencing and metagenomics.
Changes in urine microalbumin
Dates from urine test
Blood chemistry panel
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.

Full Information

First Posted
August 23, 2019
Last Updated
October 9, 2019
Sponsor
The Third Affiliated Hospital of Southern Medical University
Collaborators
Southern Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT04124211
Brief Title
Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes
Official Title
Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 25, 2019 (Actual)
Primary Completion Date
March 10, 2020 (Anticipated)
Study Completion Date
March 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Third Affiliated Hospital of Southern Medical University
Collaborators
Southern Medical University, China

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Fecal Microbiome Transplantation (FMT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FMT Arm
Arm Type
Experimental
Arm Description
10 Participants will be enrolled in this arm to receive FMT treatment
Intervention Type
Biological
Intervention Name(s)
Fecal Microbiota Transplantation (FMT)
Intervention Description
FMT will be performed through transendoscopic enteral tubing (TET) within one week during treatment period
Primary Outcome Measure Information:
Title
Changes in mean amplitude of glycemic excursion (MAGE)
Description
Dates from Continuous glucose monitoring system
Time Frame
24 Weeks
Title
Changes in standard deviation of blood glucose (SDBG)
Description
Dates from Continuous glucose monitoring system
Time Frame
24 Weeks
Title
Changes in hemoglobin A1c (HbA1c)
Description
Dates from blood chemistry test
Time Frame
24 Weeks
Title
Safety of FMT
Description
Number of all participants with treatment-related adverse events as assessed by CTCAE v4.03
Time Frame
24 Weeks
Secondary Outcome Measure Information:
Title
Changes in 24h mean blood glucose(MBG)
Description
Dates from Continuous glucose monitoring system
Time Frame
24 Weeks
Title
Changes in percentage of time of blood glucose(PT)
Description
Dates from Continuous glucose monitoring system
Time Frame
24 Weeks
Title
Changes in mean absolute glucose(MAG)
Description
Dates from Continuous glucose monitoring system
Time Frame
24 Weeks
Title
Changes in standard deviation of blood glucose(SDBG)
Description
Dates from Continuous glucose monitoring system
Time Frame
24 Weeks
Title
Changes in coefficient of variation(CV)
Description
Dates from Continuous glucose monitoring system
Time Frame
24 Weeks
Title
Changes in high blood glucose index(HBGI)
Description
Dates from Continuous glucose monitoring system
Time Frame
24 Weeks
Title
Changes in low blood glucose index(LBGI)
Description
Dates from Continuous glucose monitoring system
Time Frame
24 Weeks
Title
Changes in effective blood glucose fluctuations in frequency(NGE)
Description
Dates from Continuous glucose monitoring system
Time Frame
24 Weeks
Title
Changes in glycated albumin (GA)
Description
Dates from blood chemistry test
Time Frame
24 Weeks
Title
Changes of serum C-peptide (fasting, 30min after meal, 120min after meal)
Description
Dates from blood chemistry test
Time Frame
24 Weeks
Title
Assessment of diabetes antibodies
Description
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);
Time Frame
24 Weeks
Title
Changes in intestinal microbiome profile
Description
Changes in intestinal microbiome profile by 16s rRNA sequencing and metagenomics.
Time Frame
24 Weeks
Title
Changes in Peripheral Blood Stem Cell (PBMC)
Description
Dates from blood test
Time Frame
24 Weeks
Title
Changes in body weight to calculate body mass index (BMI)
Description
Dates from physical examination
Time Frame
24 Weeks
Title
Pathological changes of intestinal mucosa
Description
Changes in intestinal mucosa profile by enteroscopy
Time Frame
24 Weeks
Title
Changes in blood pressure
Description
Dates from physical examination
Time Frame
24 Weeks
Title
Changes in oral mucosal bacteria colonization
Description
Changes in oral mucosal bacteria by 16s rRNA sequencing and metagenomics.
Time Frame
24 Weeks
Title
Changes in urine microalbumin
Description
Dates from urine test
Time Frame
24 Weeks
Title
Blood chemistry panel
Description
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.
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daoyan Pan, MD
Phone
0086-02062784353
Email
pdy4266@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Shen, MD
Organizational Affiliation
The Third Affiliated Hospital of Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The third affiliated hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daoyan Pan, MD
Phone
0086-02062784353
Email
pdy4266@126.com
First Name & Middle Initial & Last Name & Degree
Jie Shen, MD
First Name & Middle Initial & Last Name & Degree
Ye Chen, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes

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