Clinical trial NCT04124211: Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes
Official title: Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Fecal Microbiome Transplantation (FMT)
Lead sponsor: The Third Affiliated Hospital of Southern Medical University
Sponsor class: OTHER_GOV
Collaborators: name: Southern Medical University, China
First posted: 2019-10-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Changes in mean amplitude of glycemic excursion (MAGE)
timeFrame: 24 Weeks
measure: Changes in standard deviation of blood glucose (SDBG)
timeFrame: 24 Weeks
measure: Changes in hemoglobin A1c (HbA1c)
timeFrame: 24 Weeks
measure: Safety of FMT
timeFrame: 24 Weeks
Secondary outcomes:
measure: Changes in 24h mean blood glucose(MBG)
timeFrame: 24 Weeks
measure: Changes in percentage of time of blood glucose(PT)
timeFrame: 24 Weeks
measure: Changes in mean absolute glucose(MAG)
timeFrame: 24 Weeks
measure: Changes in standard deviation of blood glucose(SDBG)
timeFrame: 24 Weeks
measure: Changes in coefficient of variation(CV)
timeFrame: 24 Weeks
measure: Changes in high blood glucose index(HBGI)
timeFrame: 24 Weeks
measure: Changes in low blood glucose index(LBGI)
timeFrame: 24 Weeks
measure: Changes in effective blood glucose fluctuations in frequency(NGE)
timeFrame: 24 Weeks
measure: Changes in glycated albumin (GA)
timeFrame: 24 Weeks
measure: Changes of serum C-peptide (fasting, 30min after meal, 120min after meal)
timeFrame: 24 Weeks
measure: Assessment of diabetes antibodies
timeFrame: 24 Weeks
measure: Changes in intestinal microbiome profile
timeFrame: 24 Weeks
measure: Changes in Peripheral Blood Stem Cell (PBMC)
timeFrame: 24 Weeks
measure: Changes in body weight to calculate body mass index (BMI)
timeFrame: 24 Weeks
measure: Pathological changes of intestinal mucosa
timeFrame: 24 Weeks
measure: Changes in blood pressure
timeFrame: 24 Weeks
measure: Changes in oral mucosal bacteria colonization
timeFrame: 24 Weeks
measure: Changes in urine microalbumin
timeFrame: 24 Weeks
measure: Blood chemistry panel
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The third affiliated hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: The Third Affiliated Hospital of Southern Medical University
name: Jie Shen, MD
role: PRINCIPAL_INVESTIGATOR
References: