Type 1 DiabetesNCT04124211
Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes
A study testing Fecal Microbiota Transplantation (FMT) in people with Type 1 Diabetes, run by The Third Affiliated Hospital of Southern Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Fecal Microbiota Transplantation (FMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2019to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The third affiliated hospital of Southern Medical University
Guangzhou, Guangdong, 510630
Daoyan Pan, MD, 0086-02062784353, pdy4266@126.com
Jie Shen, MD
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Fecal Microbiota Transplantation (FMT)
- Keywords
- Fecal Microbiome Transplantation (FMT)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplantation (FMT)Biological
FMT will be performed through transendoscopic enteral tubing (TET) within one week during treatment period
| Study group | Role | What they receive |
|---|---|---|
| FMT Arm | Experimental | 10 Participants will be enrolled in this arm to receive FMT treatment Receives: Biological: Fecal Microbiota Transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mean amplitude of glycemic excursion (MAGE)
Dates from Continuous glucose monitoring system
Measured: 24 Weeks
Changes in standard deviation of blood glucose (SDBG)
Dates from Continuous glucose monitoring system
Measured: 24 Weeks
Changes in hemoglobin A1c (HbA1c)
Dates from blood chemistry test
Measured: 24 Weeks
Safety of FMT
Number of all participants with treatment-related adverse events as assessed by CTCAE v4.03
Measured: 24 Weeks
Secondary outcomes (19)
Changes in 24h mean blood glucose(MBG)
Dates from Continuous glucose monitoring system
Measured: 24 Weeks
Changes in percentage of time of blood glucose(PT)
Dates from Continuous glucose monitoring system
Measured: 24 Weeks
Changes in mean absolute glucose(MAG)
Dates from Continuous glucose monitoring system
Measured: 24 Weeks
Changes in standard deviation of blood glucose(SDBG)
Dates from Continuous glucose monitoring system
Measured: 24 Weeks
Changes in coefficient of variation(CV)
Dates from Continuous glucose monitoring system
Measured: 24 Weeks
Changes in high blood glucose index(HBGI)
Dates from Continuous glucose monitoring system
Measured: 24 Weeks
Changes in low blood glucose index(LBGI)
Dates from Continuous glucose monitoring system
Measured: 24 Weeks
Changes in effective blood glucose fluctuations in frequency(NGE)
Dates from Continuous glucose monitoring system
Measured: 24 Weeks
Changes in glycated albumin (GA)
Dates from blood chemistry test
Measured: 24 Weeks
Changes of serum C-peptide (fasting, 30min after meal, 120min after meal)
Dates from blood chemistry test
Measured: 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);
Measured: 24 Weeks
Changes in intestinal microbiome profile
Changes in intestinal microbiome profile by 16s rRNA sequencing and metagenomics.
Measured: 24 Weeks
Changes in Peripheral Blood Stem Cell (PBMC)
Dates from blood test
Measured: 24 Weeks
Changes in body weight to calculate body mass index (BMI)
Dates from physical examination
Measured: 24 Weeks
Pathological changes of intestinal mucosa
Changes in intestinal mucosa profile by enteroscopy
Measured: 24 Weeks
Changes in blood pressure
Dates from physical examination
Measured: 24 Weeks
Changes in oral mucosal bacteria colonization
Changes in oral mucosal bacteria by 16s rRNA sequencing and metagenomics.
Measured: 24 Weeks
Changes in urine microalbumin
Dates from urine test
Measured: 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.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start25 Aug 2019
- Primary completion10 Mar 2020 (estimated)
- Study completion10 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Southern Medical University
- Sponsor type
- Other government
- Collaborators
- Southern Medical University, China
- Responsible party
- Principal investigator, Jie Shen, The Third Affiliated Hospital of Southern Medical University
- Investigators
- Jie Shen, MD, Principal investigator, The Third Affiliated Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124211
- Sponsor's protocol ID
- NYSY-NFM
- Other IDs
- 2018-lunshen-017
- Status last verified
- Oct 2019
- First submitted
- 23 Aug 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiome Transplantation (FMT) for Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04124211
- Acronym / sponsor ID
- NYSY-NFM
- Conditions
- Type 1 Diabetes
- Keywords
- Fecal Microbiome Transplantation (FMT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Southern Medical UniversityOther government
- Collaborators
- Southern Medical University, China
- Study start
- 25 Aug 2019 (actual)
- Primary completion
- 10 Mar 2020 (estimated)
- Study completion
- 10 Mar 2020 (estimated)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMT Arm | Experimental | Biological: Fecal Microbiota Transplantation (FMT)10 Participants will be enrolled in this arm to receive FMT treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (6 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota Transplantation (FMT)FMT will be performed through transendoscopic enteral tubing (TET) within one week during treatment period | Biological | FMT Arm |
Primary outcome
Changes in mean amplitude of glycemic excursion (MAGE)
Time frame: 24 Weeks
Dates from Continuous glucose monitoring system
Changes in standard deviation of blood glucose (SDBG)
Time frame: 24 Weeks
Dates from Continuous glucose monitoring system
Changes in hemoglobin A1c (HbA1c)
Time frame: 24 Weeks
Dates from blood chemistry test
Safety of FMT
Time frame: 24 Weeks
Number of all participants with treatment-related adverse events as assessed by CTCAE v4.03
19 secondary outcomes
Changes in 24h mean blood glucose(MBG)
Time frame: 24 Weeks
Changes in percentage of time of blood glucose(PT)
Time frame: 24 Weeks
Changes in mean absolute glucose(MAG)
Time frame: 24 Weeks
Changes in standard deviation of blood glucose(SDBG)
Time frame: 24 Weeks
Changes in coefficient of variation(CV)
Time frame: 24 Weeks
Changes in high blood glucose index(HBGI)
Time frame: 24 Weeks
Changes in low blood glucose index(LBGI)
Time frame: 24 Weeks
Changes in effective blood glucose fluctuations in frequency(NGE)
Time frame: 24 Weeks
Changes in glycated albumin (GA)
Time frame: 24 Weeks
Changes of serum C-peptide (fasting, 30min after meal, 120min after meal)
Time frame: 24 Weeks
Assessment of diabetes antibodies
Time frame: 24 Weeks
Changes in intestinal microbiome profile
Time frame: 24 Weeks
Changes in Peripheral Blood Stem Cell (PBMC)
Time frame: 24 Weeks
Changes in body weight to calculate body mass index (BMI)
Time frame: 24 Weeks
Pathological changes of intestinal mucosa
Time frame: 24 Weeks
Changes in blood pressure
Time frame: 24 Weeks
Changes in oral mucosal bacteria colonization
Time frame: 24 Weeks
Changes in urine microalbumin
Time frame: 24 Weeks
Blood chemistry panel
Time frame: 24 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Shen, MD principal investigator
The Third Affiliated Hospital of Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation (FMT) in people with Type 1 Diabetes, run by The Third Affiliated Hospital of Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daoyan Pan, MD (0086-02062784353, pdy4266@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in mean amplitude of glycemic excursion (MAGE) (time frame: 24 Weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.