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Plant Exosomes +/- Curcumin to Abrogate Symptoms of Inflammatory Bowel Disease

NCT04879810 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-11-03

No results posted yet for this study

Summary

The trial will test the hypothesis that edible structures within plant cells (ginger) will have clinically important anti-inflammatory effects on the gut lining of patients with inflammable bowel disease.

To evaluate the safety and tolerability of exosomes with and without curcumin in patients with Inflammatory Bowel Disease (IBD); To estimate the effect of ginger exosomes or curcumin alone or combined with curcumin on the symptoms and disease score in patients with refractory IBD describe toxicities associated with ginger exosomes; to evaluate the effect of ginger exosomes on biomarkers of inflammation.

Conditions

  • Irritable Bowel Disease

Interventions

PROCEDURE

Sigmoidoscopy and biopsy, blood work

Flexible tube up lower colon, blood draws, quality of life questionnaires

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Susan Galandiuk, MD · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2022-08-02
Completion
2022-08-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04879810 on ClinicalTrials.gov