Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes | NCT04124211

Studies
Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes

NCT04124211

Sponsor

The Third Affiliated Hospital of Southern Medical University

Status

Unknown status

Last Update Posted

Oct 11, 2019Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Type 1 Diabetes

Interventions

Fecal Microbiota Transplantation (FMT)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018-lunshen-017	Other Identifier	No.3 Affiliated Hospital of SMU

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 25, 2019Actual

Primary Completion Date

Mar 10, 2020Estimated

Completion Date

Mar 10, 2020Estimated

First Submitted Date

Aug 23, 2019

First Submission Date that Met QC Criteria

Oct 9, 2019

First Posted Date

Oct 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 9, 2019

Last Update Posted Date

Oct 11, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jie Shen, MD, Director of Endocrinology, The Third Affiliated Hospital of Southern Medical UniversityPrincipal Investigator

Lead Sponsor

The Third Affiliated Hospital of Southern Medical UniversityOTHER_GOV

Collaborators

Name	Class
Southern Medical University, China	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FMT Arm	Experimental	10 Participants will be enrolled in this arm to receive FMT treatment	Biological: Fecal Microbiota Transplantation (FMT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fecal Microbiota Transplantation (FMT)	Biological	FMT will be performed through transendoscopic enteral tubing (TET) within one week during treatment period	FMT Arm

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daoyan Pan, MD	Contact	0086-02062784353		pdy4266@126.com

Overall Officials

Name	Affiliation	Role
Jie Shen, MD	The Third Affiliated Hospital of Southern Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The third affiliated hospital of Southern Medical University	Recruiting	Guangzhou	Guangdong	510630	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D001691	Biological Therapy
D013812	Therapeutics