Ignite Creation Date:
2024-05-06 @ 1:13 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03962998
Status:
COMPLETED
Last Update Posted:
2022-06-10
First Post:
2019-05-22
Brief Title:
Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability
Sponsor:
MediBeacon
Organization:
MediBeacon
Study Overview
Official Title:
A Randomized Unblinded Feasibility Study Evaluating the Use of Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability in Normal Subjects and Subjects With Active Small Bowel Crohns Disease
Status:
COMPLETED
Status Verified Date:
2022-06
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:
None
Brief Summary:
The objectives of the study are to evaluate the safety and tolerability of oral administration of MB-102 and to evaluate the use of MB-102 as a means of measuring gut permeability in normal participants n10 and in those with radiologic evidence of small bowel Crohns disease n10
Detailed Description:
This study is a single center randomized open label cross-over study evaluating MB-102 versus dual sugar testing using lactulose and rhamnose for the assessment of gut permeability Participants will be screened within 30 days of Day 1 and eligible participants will be randomized to receive either an oral dose of MB-102 or the dual sugar test on Day 1 At a second study visit occurring between 3 to 7 days after completion of the first test participants will return to the study center for the second test Following completion of the second test participants will return to the study center 7 3 days for a follow-up visit to evaluate safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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