Ignite Creation Date:
2025-12-18 @ 8:18 AM
Ignite Modification Date:
2025-12-18 @ 8:18 AM
Study NCT ID:
NCT05622123
Status:
None
Last Update Posted:
2023-04-04 00:00:00
First Post:
2022-11-08 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BetaFIT Study: Beta Cell Imaging After Faecal mIcrobiota Transplantation
Sponsor:
None
Organization:
Study Overview
Official Title:
The Effects of Faecal Microbiota Transplantation on Beta Cell Preservation in Patients With Newly Diagnosed Type 1 Diabetes
Status:
None
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BetaFIT
Brief Summary:
The incidence of Type 1 Diabetes Mellitus (T1D) has tripled in the last thirty years, and T1D is associated with a lifelong increase of considerable morbidity and mortality compared to healthy subjects. As the increased T1D incidence is primarily observed in subjects who are not genetically predisposed, environmental factors including altered diet, antibiotic use as well as mode of birth have been suggested to play a role, and these factors have invariably been linked to changes in the gut microbiome. Indeed, an altered composition of the faecal microbiota composition was observed in adolescent T1D patients. A previous study by de Groot et al. (2021) showed that faecal microbiota transplantation stops the decline in endogenous insulin production in newly diagnosed type 1 diabetes patients. However, it is unknown whether this is due to an increase in beta cell mass, or increased function of the remaining beta cells.
In this study, the investigators aim to investigate whether beta cell mass (quantified by 68Ga-NODAGA-exendin-4 PET/CT imaging) is correlated to beta cell function after autologous faecal microbial transplantation in patients with newly diagnosed type 1 diabetes.
In this study, the investigators aim to investigate whether beta cell mass (quantified by 68Ga-NODAGA-exendin-4 PET/CT imaging) is correlated to beta cell function after autologous faecal microbial transplantation in patients with newly diagnosed type 1 diabetes.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: