- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03962998
Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability
June 8, 2022 updated by: MediBeacon
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
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University in St. Louis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lactulose/Rhamnose
1000 mg of lactulose and 200 mg of rhamnose administered orally as a 10 mL solution
|
Lactulose/Rhamnose solution administered orally followed by measurement of excreted lactulose and rhamnose in urine
|
Experimental: MB-102
4 μmol of MB-102/kg body weight administered orally as a solution
|
MB-102 solution administered orally followed by measurement of excreted MB-102 in urine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Richard B Dorshow, PhD, MediBeacon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 27, 2019
Primary Completion (Actual)
October 5, 2021
Study Completion (Actual)
October 5, 2021
Study Registration Dates
First Submitted
May 22, 2019
First Submitted That Met QC Criteria
May 22, 2019
First Posted (Actual)
May 24, 2019
Study Record Updates
Last Update Posted (Actual)
June 10, 2022
Last Update Submitted That Met QC Criteria
June 8, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MB-300-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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