NCT03962998

Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability

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 Crohn's Disease

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: MediBeacon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 (n=10) and in those with radiologic evidence of small bowel Crohn's disease (n=10).

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Lactulose/Rhamnose solution	Lactulose/Rhamnose solution administered orally followed by measurement of excreted lactulose and rhamnose in urine
DRUG	MB-102	MB-102 solution administered orally followed by measurement of excreted MB-102 in urine

Timeline

• Start date: 2019-10-27
• Primary completion: 2021-10-05
• Completion: 2021-10-05
• First posted: 2019-05-24
• Last updated: 2022-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study