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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Lactulose/Rhamnose
1000 mg of lactulose and 200 mg of rhamnose administered orally as a 10 mL solution
Drug: Lactulose/Rhamnose 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
Drug: MB-102
MB-102 solution administered orally followed by measurement of excreted MB-102 in urine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MediBeacon

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 5, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 24, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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