Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749030
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2021-02-01
Brief Title:
Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Faecal Microbiota Transplantation for Patients With Diabetes Mellitus Type 1 and Severe Gastrointestinal Neuropathy a Randomised Double-blinded Safety and Pilot-efficacy Study
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
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:
Fadigas
Brief Summary:
A randomised double-blinded and placebo-controlled intervention study The study aim to evaluate the feasibility safety and pilot-efficacy of faecal microbiota transplantation as a treatment of severe gastrointestinal neuropathy in patients with diabetes mellitus type 1
Detailed Description:
Diabetes type 1 may cause damage to nerve cells in the gut causing neuropathy that leads to changes in gastric and intestinal motility This change predisposes to an abnormal amounts and composition of bacteria in the gut probably leading to uncontrollable diarrhea and severely impaired quality of life Transferal of intestinal microbiota from a healthy donor to a patient is called faecal microbiota transplantation FMT FMT may potentially change the bacteria in the gut and reduce gastrointestinal symptoms However FMT may also have potential side effects especially in persons with autonomic neuropathy and delayed transit through the gut
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None