Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability
Primary Purpose
Crohn Disease
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lactulose/Rhamnose solution
MB-102
Sponsored by
About this trial
This is an interventional diagnostic trial for Crohn Disease focused on measuring Gut permeability, Intestinal permeability, MB-102
Eligibility 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)
Sites / Locations
- Washington University in St. Louis
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Lactulose/Rhamnose
MB-102
Arm Description
1000 mg of lactulose and 200 mg of rhamnose administered orally as a 10 mL solution
4 μmol of MB-102/kg body weight administered orally as a solution
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03962998
Brief Title
Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
October 27, 2019 (Actual)
Primary Completion Date
October 5, 2021 (Actual)
Study Completion Date
October 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MediBeacon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease
Keywords
Gut permeability, Intestinal permeability, MB-102
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactulose/Rhamnose
Arm Type
Active Comparator
Arm Description
1000 mg of lactulose and 200 mg of rhamnose administered orally as a 10 mL solution
Arm Title
MB-102
Arm Type
Experimental
Arm Description
4 μmol of MB-102/kg body weight administered orally as a solution
Intervention Type
Drug
Intervention Name(s)
Lactulose/Rhamnose solution
Intervention Description
Lactulose/Rhamnose solution administered orally followed by measurement of excreted lactulose and rhamnose in urine
Intervention Type
Drug
Intervention Name(s)
MB-102
Intervention Description
MB-102 solution administered orally followed by measurement of excreted MB-102 in urine
Primary Outcome Measure Information:
Title
Mean urine concentration of MB-102 over time in normal participants and in those with Crohn's disease
Description
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
Secondary Outcome Measure Information:
Title
Correlation between MB-102 excretion and the results of dual sugar testing in normal participants and in those with Crohn's disease
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard B Dorshow, PhD
Organizational Affiliation
MediBeacon
Official's Role
Study Director
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability
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