Crohn DiseaseEarly Phase 1NCT03962998
Oral Administration of MB-102 Versus Dual Sugar Testing for Gut Permeability
A Early Phase 1 study testing Lactulose/Rhamnose solution and MB-102 in people with Crohn Disease, run by MediBeacon at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Lactulose/Rhamnose solution and MB-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2019to 5 Oct 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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
Who cannot join
- 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
Show all 32Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
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
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).
Read the 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.
- Conditions
- Crohn Disease
- Being tested
- Lactulose/Rhamnose solution, MB-102
- Keywords
- Gut permeability, Intestinal permeability, MB-102
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactulose/Rhamnose solutionDrug
Lactulose/Rhamnose solution administered orally followed by measurement of excreted lactulose and rhamnose in urine
MB-102Drug
MB-102 solution administered orally followed by measurement of excreted MB-102 in urine
| Study group | Role | What they receive |
|---|---|---|
| Lactulose/Rhamnose | Active comparator | 1000 mg of lactulose and 200 mg of rhamnose administered orally as a 10 mL solution Receives: Drug: Lactulose/Rhamnose solution |
| MB-102 | Experimental | 4 μmol of MB-102/kg body weight administered orally as a solution Receives: Drug: MB-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours
Secondary outcomes (1)
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.
Measured: Pre-dose and 1, 2, 4, 6, 8, 10, and 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start27 Oct 2019
- Primary completion5 Oct 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- MediBeacon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard B Dorshow, PhD, Study director, MediBeacon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962998
- Sponsor's protocol ID
- MB-300-01
- Status last verified
- Jun 2022
- First submitted
- 22 May 2019
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03962998
- Acronym / sponsor ID
- MB-300-01
- Conditions
- Crohn Disease
- Keywords
- Gut permeability, Intestinal permeability, MB-102
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- MediBeaconIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2019 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulose/Rhamnose | Active comparator | Drug: Lactulose/Rhamnose solution1000 mg of lactulose and 200 mg of rhamnose administered orally as a 10 mL solution |
| MB-102 | Experimental | Drug: MB-1024 μmol of MB-102/kg body weight administered orally as a solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactulose/Rhamnose solutionLactulose/Rhamnose solution administered orally followed by measurement of excreted lactulose and rhamnose in urine | Drug | Lactulose/Rhamnose |
| MB-102MB-102 solution administered orally followed by measurement of excreted MB-102 in urine | Drug | MB-102 |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard B Dorshow, PhD study director
MediBeacon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lactulose/Rhamnose solution and MB-102 in people with Crohn Disease, run by MediBeacon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.