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

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2022
• Main ID: NCT03962998
• Date of registration: 22/05/2019
• Prospective Registration: Yes
• Primary sponsor: MediBeacon
• Public title: Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability
• Scientific 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 Crohn's Disease
• Date of first enrolment: October 27, 2019
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03962998
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Richard B Dorshow, PhD
• Affiliation: MediBeacon

Key inclusion & exclusion criteria

Inclusion criteria for all participants:

- Age > 18 years - male or non-pregnant or lactating females

- Participants willing to comply with study requirements

- Participants who have signed an informed consent form

- Normal or non-clinically significant screening and baseline 12 lead electrocardiogram
(ECG) in the opinion of the principal investigator (PI)

- Estimated glomerulofiltration rate (eGFR) > 75 mL/min/1.73 m^2

- Agreement to not utilize nonsteroidal anti-inflammatory drugs (NSAIDs) until study
completion.

Inclusion criteria for participants with Crohn's disease:

- Participants with active small bowel Crohn's disease diagnosed by an abnormal Magnetic
Resonance Enterography (MRE) within 1 month prior to screening

- Active Crohn's disease must be characterized by mucosal hyperemia, and/or bowel wall
thickening and/or vascular engorgement

Exclusion criteria for all participants:

- Women who are pregnant, lactating, or planning to become pregnant during the study, or
women who are of childbearing potential unwilling to use an adequate method of birth
control a. Males must be willing to practice abstinence or utilize adequate
contraception from dosing day to at least 7 days post dose

- Participation in another interventional trial within 30 days of dosing or concurrently
enrolled in any other medical research study which could impact the results of the
study

- Unable to tolerate an overnight fast

- NSAID use within 14 days of Day 1

- History of drug or alcohol abuse within the past year

- Diagnosis of ulcerative colitis, indeterminate colitis, pseudomembranous colitis, or
celiac disease

- Prior or current diagnosis of an autoimmune disease

- Gastrointestinal surgery (including appendectomy) within 12 weeks prior to screening
or has surgery planned or deemed likely to require surgery during the study

- Type 1 or 2 diabetes

- History of severe allergic hypersensitivity reactions (unacceptable adverse events) or
anaphylactoid reaction to any allergen including drugs, or MB-102 (intolerance to a
drug is not considered a drug allergy)

- Known history of testing positive for acquired immunodeficiency syndrome (AIDS) or
human immunodeficiency virus (HIV)

- Site personnel immediately associated with the study or their immediate family members

- Any characteristics which, in the opinion of the investigator, makes the participant a
poor candidate for participation in the clinical trial

- Prior exposure to MB-102

- Any changes to chronic medication therapy or initiation of new medications between
Testing Day 1 and Testing Day 2

- Current urinary tract infection

- Body mass index > 30 kg/m^2

- Prior history of small bowel malignancy or resection surgery

- Unable to meet the requirements of the study including 12+ hour study visits

Additional exclusion criteria for normal participants:

- Fecal transplant within 1 year

- Prior or current graft-vs.-host disease

- Prior or current history of diverticulitis

- Current or prior history of fatty liver

- Current use of any biologic therapy or current use of the following medications:
sulfasalazine, mesalamine, olsalazine, balsalazide, prednisone, cyclosporine,
azathioprine, 6-mercaptopurine, tacrolimus, methotrexate, intravenous immunoglobulin,
anti-diarrheal agents

- Prior antibiotic therapy within 30 days of screening

- Undiagnosed chronic gastrointestinal upset or food intolerance history

- Recent history of significant unplanned weight loss, blood in the stool or acute
episodes of diarrhea

- First-degree relative (sibling, parent, child) has inflammatory bowel disease (Crohn's
disease, ulcerative colitis, proctitis, indeterminate colitis)

- History of Crohn's disease

Additional exclusion criterion for participants with Crohn's disease:

- Participant on Total Parenteral Nutrition (TPN)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Drug: MB-102

Drug: Lactulose/Rhamnose solution

Primary Outcome(s)

Mean urine concentration of MB-102 over time in normal participants and in those with Crohn's disease [Time Frame: Pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours]

Secondary Outcome(s)

Correlation between MB-102 excretion and the results of dual sugar testing in normal participants and in those with Crohn's disease [Time Frame: Pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours]

Secondary ID(s)

MB-300-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors