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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
22
Lactulose/Rhamnose solution administered orally followed by measurement of excreted lactulose and rhamnose in urine
MB-102 solution administered orally followed by measurement of excreted MB-102 in urine
Washington University in St. Louis
St Louis, Missouri, United States
Mean urine concentration of MB-102 over time in normal participants and in those with Crohn's disease
Urine samples will be collected pre-dose (time 0), each time the participant voids, and at the protocol-defined time points after oral administration of MB-102. The total volume of urine excreted will be recorded. Urine samples will be analyzed using validated analytical methods.
Time frame: Pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours
Correlation between MB-102 excretion and the results of dual sugar testing in normal participants and in those with Crohn's disease
For MB-102 excretion evaluation, urine samples will be collected pre-dose (time 0), each time the participant voids, and at the protocol-defined time points after oral administration of MB-102. The total volume of urine excreted will be recorded. Urine samples will be analyzed using validated analytical methods. For the dual sugar test, participants will consume a 10 mL solution (1000 mg of lactulose and 200 mg of rhamnose). Urine will be collected pre-dose (time 0), each time the participant voids, and at the protocol-defined time points after consuming the sugar solution. The total volume of urine excreted will be recorded. Urine samples will be analyzed using validated analytical methods.
Time frame: Pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours
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