Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes

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.

Study Overview

• Status: Unknown
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Biological: Fecal Microbiota Transplantation (FMT)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Recruiting
      • The Third Affiliated Hospital of Southern Medical University
      • Contact: Daoyan Pan, MD; Phone Number: 0086-02062784353; Email: pdy4266@126.com
      • Principal Investigator: Jie Shen, MD
      • Principal Investigator: Ye Chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in mean amplitude of glycemic excursion (MAGE)	Dates from Continuous glucose monitoring system	24 Weeks
Changes in standard deviation of blood glucose (SDBG)	Dates from Continuous glucose monitoring system	24 Weeks
Changes in hemoglobin A1c (HbA1c)	Dates from blood chemistry test	24 Weeks
Safety of FMT	Number of all participants with treatment-related adverse events as assessed by CTCAE v4.03	24 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The Third Affiliated Hospital of Southern Medical University
• Collaborators: Southern Medical University, China
• Investigators: Principal Investigator: Jie Shen, MD, The Third Affiliated Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2019
• Primary Completion (Anticipated): March 10, 2020
• Study Completion (Anticipated): March 10, 2020

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Fecal Microbiome Transplantation (FMT)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: NYSY-NFM; 2018-lunshen-017 (Other Identifier: No.3 Affiliated Hospital of SMU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No