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

Pilot Clinical Trial Investigating the Ability of Plant Exosomes +/- Curcumin to Abrogate Symptoms of Inflammatory Bowel Disease (IBD)

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Disease
• Intervention / Treatment: Procedure: Sigmoidoscopy and biopsy, blood work

Detailed Description

Up to 90 patients with Chronic IBD will be enrolled, with the goal of having three arms of 30 subjects in each group who are eligible for evaluation.

This exploratory trial is designed to estimate the effect of ginger exosomes or curcumin on IBD symptoms compared to ginger exosomes plus curcumin. In this prospective and randomized study the main focus is to compare exosomes alone, curcumin, and exosomes plus curcumin. Three primary stratification factors race (white and black), gender and type of IBD (CD and UC) will be used. plan Zelen's (1974) method will be used to avoid imbalance allocation within each stratum. A block size of 4 will be used. We plan to enroll all eligible patients visiting the clinic, as well as eligible patients referred from other gastroenterologists. All eligible visiting our clinic will be enrolled. By enrolling consecutive patients, we reduce selection bias. A patient will be enrolled only once.

The most important aim of this study is to compare the IBD symptoms in exosomes alone and exosomes plus curcumin groups of patients. The symptomatology will be measured in each group and compared to the self-reported score. We will use the incidence rate of bloody stool to justify the sample size. With the combination treatment (ginger exosomes plus curcumin as compared to curcumin alone) we hope to reduce symptoms by at least 30%. Using a two sample one-sided t test for comparing mean differences in Inflammatory Bowel Disease Questionnaire, with 30 subjects in each group and using alpha=5%, we will have 80% power to detect effect size of 0.65 Standard Deviation, which is a large effect size (Cohen, 1988).. When the reduction in sample size due to missing data or other reasons, we will have reduced power to detect the difference in two groups.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40292
      • University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must have a confirmed diagnosis of IBD (either CD or UC) with moderate disease activity.)
• Ability to independently care for oneself

Exclusion Criteria:

• Pregnancy
• Known HIV
• Patients receiving immunosuppressive drugs, other than for their bowel disease
• Patients must be on stable doses of their medications for the 2 weeks prior to study entry and for the duration of the treatment period, or inform the investigator of any changes in medication
• Active malignancy in the last 5 years
• Patients receiving any other investigational agent(s)
• Ginger allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ginger exosomes; Study mixture will be taken PO daily times 28 days Sigmoidoscopy and biopsy, blood work, quality of life questionnaire	Procedure: Sigmoidoscopy and biopsy, blood work; Flexible tube up lower colon, blood draws, quality of life questionnaires; Other Names: Inflammatory Bowel Disease Questionnaire
Active Comparator: Curcumin; Study mixture will be taken PO daily times 28 days Sigmoidoscopy and biopsy, blood work, quality of life questionnaire	Procedure: Sigmoidoscopy and biopsy, blood work; Flexible tube up lower colon, blood draws, quality of life questionnaires; Other Names: Inflammatory Bowel Disease Questionnaire
Active Comparator: Ginger exosomes plus curcumin; Study mixture will be taken PO daily times 28 days Sigmoidoscopy and biopsy, blood work, quality of life questionnaire	Procedure: Sigmoidoscopy and biopsy, blood work; Flexible tube up lower colon, blood draws, quality of life questionnaires; Other Names: Inflammatory Bowel Disease Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammation on Colonoscopy	Decrease in inflammatory cells in the biopsy after treatment versus before treatment.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Subjective symptoms	Questionnaire reporting of decrease in subjective symptoms.	30 days

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Susan Galandiuk, MD, University of Louisville

Publications and helpful links

General Publications

• Zhang M, Viennois E, Prasad M, Zhang Y, Wang L, Zhang Z, Han MK, Xiao B, Xu C, Srinivasan S, Merlin D. Edible ginger-derived nanoparticles: A novel therapeutic approach for the prevention and treatment of inflammatory bowel disease and colitis-associated cancer. Biomaterials. 2016 Sep;101:321-40. doi: 10.1016/j.biomaterials.2016.06.018. Epub 2016 Jun 9.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): August 2, 2022
• Study Completion (Actual): August 2, 2022

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases, Functional; Colonic Diseases; Irritable Bowel Syndrome; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 15.0872

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: No
• Studies a U.S. FDA-regulated device product: No