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

Crohn Disease Clinical Trial

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 Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03962998
• Other study ID #: MB-300-01
• Status: Completed
• Phase: Early Phase 1
• Start date: October 27, 2019
• Est. completion date: October 5, 2021

Study information

• Verified date: June 2022
• Source: MediBeacon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 5, 2021
• Est. primary completion date: October 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• Lactulose/Rhamnose solution
Lactulose/Rhamnose solution administered orally followed by measurement of excreted lactulose and rhamnose in urine
• MB-102
MB-102 solution administered orally followed by measurement of excreted MB-102 in urine

Locations

Country	Name	City	State
United States	Washington University in St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
MediBeacon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours
Secondary	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.	Pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours