Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355583
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2023-10-03
Brief Title:
Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant MAST Trial
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
Intestinal Microbiota Transplant Prior to Allogeneic Stem Cell Transplant MAST Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
MAST
Brief Summary:
The goal of this clinical trial is to test the ability to restore gut microbiota to healthier levels in patients with blood cancers scheduled to have stem cell transplant
The main questions it aims to answer are
Tolerability and acceptability of intestinal microbiota transplantation IMT versus placebo as assessed via patient perspective questionnaires
Changes in gut microbiome diversity across all timepoints
Markers of general health infectivemicrobiological and haematological outcomes including days of fever admission to intensive care unit survival non-relapsed mortality and incidence of graft-versus-host disease across all time points measured
Participants will be asked at their routine follow up visits to
Provide stool urine and blood samples at the scheduled study visits
Complete questionnaires at selected visits
Swallow either Placebo or IMT capsules once at the second study visit which will occur 2 weeks prior to the stem cell transplant -3 days
Researchers will compare IMT capsules and Placebo to investigate the change in gut microbiota diversity
The main questions it aims to answer are
Tolerability and acceptability of intestinal microbiota transplantation IMT versus placebo as assessed via patient perspective questionnaires
Changes in gut microbiome diversity across all timepoints
Markers of general health infectivemicrobiological and haematological outcomes including days of fever admission to intensive care unit survival non-relapsed mortality and incidence of graft-versus-host disease across all time points measured
Participants will be asked at their routine follow up visits to
Provide stool urine and blood samples at the scheduled study visits
Complete questionnaires at selected visits
Swallow either Placebo or IMT capsules once at the second study visit which will occur 2 weeks prior to the stem cell transplant -3 days
Researchers will compare IMT capsules and Placebo to investigate the change in gut microbiota diversity
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-003617-10 | EUDRACT_NUMBER | None | None |