Whey Protein Milk-Derived Exosomes

Launched by EXOSOMM LTD. · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new supplement called WPMDE2, which is made from whey protein milk-derived exosomes. It aims to find out if this supplement is safe and can help improve symptoms for adults with ulcerative colitis (UC), a condition that causes inflammation in the colon. The study will last for 8 weeks, followed by a 2-week check-up period, and will involve 100 participants who have mild to severe UC. Researchers will look for improvements in how participants feel, their disease activity, and certain markers of inflammation in the body.

To be eligible for this trial, participants must be between 18 and 65 years old and have a confirmed diagnosis of ulcerative colitis. They should also have signs of inflammation in their colon, as seen through medical tests. However, individuals who are pregnant or breastfeeding, have a milk allergy, or certain severe medical conditions won't be able to participate. Throughout the study, participants will take the supplement and report on their experiences, helping researchers understand its safety and potential benefits for managing ulcerative colitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • A confirmed clinical diagnosis of UC of any duration
• • Age 18-65 years
• • Signed informed consent
• • Presence of endoscopic evidence of colonic inflammation
• Exclusion Criteria:
• • Pregnancy or breastfeeding
• • Milk allergy
• • Severe co-morbid medical illness such as uncontrolled diabetes, unstable cardiovascular or pulmonary disease, or malignancy
• • Specific exclusions: HIV , CMV , Hepatitis B or C, Abnormal AST or ALT at screening defined as \> 3x upper limit of normal
• • Participating in another investigational drug study within 30 days of study enrollment
• • Evidence of colonic perforation
• • Massive hemorrhage from the colon requiring emergent surgery