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

NCT03962998 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-06-10

No results posted yet for this study

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).

Conditions

  • Crohn Disease

Interventions

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

Sponsors & Collaborators

  • MediBeacon

    lead INDUSTRY

Principal Investigators

  • Richard B Dorshow, PhD · MediBeacon

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-27
Primary Completion
2021-10-05
Completion
2021-10-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03962998 on ClinicalTrials.gov