NCT04124211

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

August 25, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 11, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

October 11, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

August 23, 2019

Last Update Submit

October 9, 2019

Conditions

Type 1 Diabetes

Keywords

Fecal Microbiome Transplantation (FMT)

Outcome Measures

Primary Outcomes (4)

  • 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 (19)

  • Changes in 24h mean blood glucose(MBG)

    24 Weeks

  • Changes in percentage of time of blood glucose(PT)

    24 Weeks

  • Changes in mean absolute glucose(MAG)

    24 Weeks

  • Changes in standard deviation of blood glucose(SDBG)

    24 Weeks

  • Changes in coefficient of variation(CV)

    24 Weeks

  • +14 more secondary outcomes

Study Arms (1)

FMT Arm

EXPERIMENTAL

10 Participants will be enrolled in this arm to receive FMT treatment

Biological: Fecal Microbiota Transplantation (FMT)

Interventions

Fecal Microbiota Transplantation (FMT)BIOLOGICAL

FMT will be performed through transendoscopic enteral tubing (TET) within one week during treatment period

FMT Arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The third affiliated hospital of Southern Medical University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Jie Shen, MD

    The Third Affiliated Hospital of Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daoyan Pan, MD

CONTACT

0086-02062784353pdy4266@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Director of Endocrinology

Study Record Dates

First Submitted

August 23, 2019

First Posted

October 11, 2019

Study Start

August 25, 2019

Primary Completion

March 10, 2020

Study Completion

March 10, 2020

Last Updated

October 11, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)