Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04124211
• Other study ID #: NYSY-NFM
• Secondary ID: 2018-lunshen-017
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2019
• Est. completion date: March 10, 2020

Study information

• Verified date: October 2019
• Source: The Third Affiliated Hospital of Southern Medical University
• Contact: Daoyan Pan, MD
• Phone: 0086-02062784353
• Email: pdy4266[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 10, 2020
• Est. primary completion date: March 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Biological:
• Fecal Microbiota Transplantation (FMT)
FMT will be performed through transendoscopic enteral tubing (TET) within one week during treatment period

Locations

Country	Name	City	State
China	The third affiliated hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
The Third Affiliated Hospital of Southern Medical University	Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in mean amplitude of glycemic excursion (MAGE)	Dates from Continuous glucose monitoring system	24 Weeks
Primary	Changes in standard deviation of blood glucose (SDBG)	Dates from Continuous glucose monitoring system	24 Weeks
Primary	Changes in hemoglobin A1c (HbA1c)	Dates from blood chemistry test	24 Weeks
Primary	Safety of FMT	Number of all participants with treatment-related adverse events as assessed by CTCAE v4.03	24 Weeks
Secondary	Changes in 24h mean blood glucose(MBG)	Dates from Continuous glucose monitoring system	24 Weeks
Secondary	Changes in percentage of time of blood glucose(PT)	Dates from Continuous glucose monitoring system	24 Weeks
Secondary	Changes in mean absolute glucose(MAG)	Dates from Continuous glucose monitoring system	24 Weeks
Secondary	Changes in standard deviation of blood glucose(SDBG)	Dates from Continuous glucose monitoring system	24 Weeks
Secondary	Changes in coefficient of variation(CV)	Dates from Continuous glucose monitoring system	24 Weeks
Secondary	Changes in high blood glucose index(HBGI)	Dates from Continuous glucose monitoring system	24 Weeks
Secondary	Changes in low blood glucose index(LBGI)	Dates from Continuous glucose monitoring system	24 Weeks
Secondary	Changes in effective blood glucose fluctuations in frequency(NGE)	Dates from Continuous glucose monitoring system	24 Weeks
Secondary	Changes in glycated albumin (GA)	Dates from blood chemistry test	24 Weeks
Secondary	Changes of serum C-peptide (fasting, 30min after meal, 120min after meal)	Dates from blood chemistry test	24 Weeks
Secondary	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
Secondary	Changes in intestinal microbiome profile	Changes in intestinal microbiome profile by 16s rRNA sequencing and metagenomics.	24 Weeks
Secondary	Changes in Peripheral Blood Stem Cell (PBMC)	Dates from blood test	24 Weeks
Secondary	Changes in body weight to calculate body mass index (BMI)	Dates from physical examination	24 Weeks
Secondary	Pathological changes of intestinal mucosa	Changes in intestinal mucosa profile by enteroscopy	24 Weeks
Secondary	Changes in blood pressure	Dates from physical examination	24 Weeks
Secondary	Changes in oral mucosal bacteria colonization	Changes in oral mucosal bacteria by 16s rRNA sequencing and metagenomics.	24 Weeks
Secondary	Changes in urine microalbumin	Dates from urine test	24 Weeks
Secondary	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