An interventional study of Whey Protein Milk-Derived Exosomes in Ulcerative Colitis and Inflammatory Bowel Disease, sponsored by Exosomm Ltd.. Completed at 4 sites in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Exosomm Ltd. · Not applicable, Interventional, and Treatment
This Phase 1B open-label, uncontrolled multicenter trial evaluates the safety, tolerability, and potential efficacy of WPMDE2, a whey protein milk-derived exosome supplement, in adult patients with mild to severe ulcerative colitis (UC). The study aims to explore clinical improvements in disease activity, quality of life, and inflammatory markers over an 8-week intervention period with a 2-week follow-up. WPMDE2 is administered orally in two dosage groups, with 100 participants stratified by disease severity. Key endpoints include changes in disease severity, fecal calprotectin levels, and patient-reported outcomes. Conducted under ethical guidelines, the study seeks to establish WPMDE2 as a safe, naturally derived adjunct therapy for UC patients.
This is a Phase 1B open-label, uncontrolled, multicenter trial designed to evaluate the safety, tolerability, and potential efficacy of WPMDE2 (Whey Protein Milk-Derived Exosomes) in adult patients with varying severities of ulcerative colitis (UC). The study builds upon promising preclinical research and a preceding Phase 1 safety study in healthy volunteers, which demonstrated that WPMDE2 has a favorable safety profile and potential anti-inflammatory benefits. By targeting patients with mild to severe UC, the trial seeks to explore WPMDE2's therapeutic role as an add-on to existing treatment regimens.
Study Objectives
Primary Objectives:
Evaluate the safety and tolerability of WPMDE2 when administered orally at two different dosages.
Assess the clinical benefits of WPMDE2 by measuring changes in disease severity.
Secondary Objectives:
Investigate improvements in quality of life (QoL) using the IBDQ-32 questionnaire.
Monitor changes in inflammatory biomarkers, including fecal calprotectin. Assess endoscopic improvements and other patient-reported outcomes, such as stool frequency, rectal bleeding, and abdominal pain.
Study Design This trial is an open-label, uncontrolled study involving multiple centers in Israel, with potential sites abroad. Participants will receive WPMDE2 in one of two dosage groups (X and 2X) for 8 weeks, followed by a 2-week follow-up period. The design accommodates real-world applicability by allowing participants to continue their standard UC treatments while taking WPMDE2.
Key Features:
Study Type: Interventional Intervention Model: Sequential allocation into two dosage groups. Primary Purpose: Exploratory evaluation of safety and efficacy. sample size:
A total of 100 patients with confirmed UC will be enrolled:
Intervention Details
Product Description:
WPMDE2 is a powder derived from milk, enriched with naturally occurring extracellular vesicles (EVs). These EVs contain bioactive components, including proteins, lipids, and microRNAs, which exhibit immunomodulatory and anti-inflammatory properties. Participants will take the powder dissolved in water twice daily, with doses stratified into two groups: 5g and 10g.
WPMDE2 has been optimized to preserve the structural integrity of its active components. Its safety was confirmed in Phase 1 studies involving healthy volunteers.
Administration:
Participants will be provided with pack with powder with measuring spoon to prepare the solution.Oral administration will occur twice daily for 8 weeks.
Study Procedures
Participants will attend four scheduled visits:
V0 (Screening): Initial assessment, including blood and stool tests, endoscopic evaluation (optional), and eligibility screening.
V1 (Baseline): Randomization and initial intervention. V2 (End of Treatment): Final assessment of treatment impact, including blood and stool tests, endoscopic evaluation, and patient-reported outcomes.
V3 (Follow-up): Virtual visit 2 weeks post-treatment for safety monitoring. Daily Diaries: Participants will record adherence, symptoms (e.g., rectal bleeding, stool frequency), and any new medications.
*Colonoscopy will be considered the gold standard for the diagnosis of ulcerative colitis (UC). Before recruitment, colonoscopy results will be collected for each subject to evaluate and determine the diagnosis of UC. Only available examination results that meet the study's needs will be collected.
At the end of the trial (EOT), a colonoscopy will be performed based on the sponsor's decision, with a maximum of 15 subjects eligible. Participation in this examination will be optional.
For patients who consent to endoscopic evaluation, special attention will be given to the quality control of endoscopic data. A central reviewer will assess all endoscopic images to ensure consistent scoring across sites. However, since endoscopy is optional, the analysis plans will account for potential missing endoscopic data.
Endpoints
Primary Endpoints:
Changes in disease severity from baseline to week 8. Incidence of adverse events and changes in vital signs or laboratory results.
Secondary Endpoints:
Reduction in inflammatory biomarkers, such as fecal calprotectin. Endoscopic improvement in mucosal healing. Improvements in quality of life as measured by IBDQ-32. Patient-reported outcomes, including stool frequency and abdominal pain. Statistical Considerations Sample Size: 100 participants, providing sufficient power to detect meaningful differences.
Analysis Populations: Intention-to-Treat (ITT) and Per-Protocol (PP).
Handling Missing Data: Multiple imputation techniques will ensure robust ITT analysis.
Ethical Considerations The study adheres to the Declaration of Helsinki and relevant regulatory guidelines. Ethical approval has been obtained from IRBs at participating centers. Participants will provide informed consent before enrolling, and their safety will be closely monitored throughout the study. Adverse events will be reported promptly, with provisions for discontinuing the intervention if necessary.
Expected Outcomes If successful, this trial will provide evidence for WPMDE2 as a safe, naturally derived adjunct therapy for UC. Findings will inform the design of future controlled trials, potentially leading to a novel therapeutic option for patients with inflammatory bowel disease.
Timelines Site Initiation: Within 3 month of IRB approval. Recruitment: Over 8 months. Intervention Period: 8 weeks per participant. Follow-up and Analysis: Completed within 3 months of the last patient visit. This study represents an innovative approach to leveraging milk-derived bioactive components to address unmet needs in UC management.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's enrollment of 31 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →Exosomm Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be sequentially allocated to the two dosage groups in a 1:1 ratio: dosage X and dosage 2X and stratified by disease severity
Dietary Supplement: Whey Protein Milk-Derived Exosomes
WPMDE2 (Whey Protein Milk-Derived Exosomes 2) is an advanced nutritional supplement developed from natural milk components.
Clinical Benefit #1
\- Change in disease activity as measured by clinical activity index from baseline to end of treatment
Time frame: 12 months
Clinical Benefits #2
\- Comparison of clinical benefits between the two dosage groups measured by clinical activity index from baseline to end of treatment
Time frame: 12 months
Safety and Tolerability of WPMDE2 #1
\- Incidence and severity of adverse events.
Time frame: 12 months
Change in inflammatory biomarkers #1
\- Fecal calprotectin levels
Time frame: 12 months
Change in inflammatory biomarkers #2
\- Change in endoscopic subscore of the clinical activity index from baseline to end of treatment
Time frame: 12 months
Improvement in the quality of life
Improvement in the quality of life as measured by IBDQ-32
Time frame: 12 months
Patient-reported outcomes #1
Changes in stool frequency assessed by the IBDQ-32 questionnaire Changes in rectal bleeding Changes in abdominal pain/discomfort
Time frame: 12 months
Patient-reported outcomes #2
Changes in rectal bleeding assessed by the IBDQ-32 questionnaire
Time frame: 12 months
Dose-response relationship:
Comparison of all endpoints between the two dosage groups to assess dose-response effects measured by the change in clinical activity index from baseline to end of treatment.
Time frame: 12 months
Ran from Mar 2025 to primary completion in Apr 2026, 12 months.
Of 236 interventional studies with no phase under Colitis, Ulcerative, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 54. This study's 12 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: start Feb 2025 → Mar 2025, primary completion Feb 2026 → Apr 2026 and completion Apr 2026 → Jun 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Exosomm Ltd.