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

NCT ID: NCT04879810

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2022-08-02

Brief 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.

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.

Conditions

Irritable Bowel Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ginger exosomes

Study mixture will be taken PO daily times 28 days Sigmoidoscopy and biopsy, blood work, quality of life questionnaire

Group Type: ACTIVE_COMPARATOR

Sigmoidoscopy and biopsy, blood work

Intervention Type: PROCEDURE

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

Curcumin

Study mixture will be taken PO daily times 28 days Sigmoidoscopy and biopsy, blood work, quality of life questionnaire

Group Type: ACTIVE_COMPARATOR

Sigmoidoscopy and biopsy, blood work

Intervention Type: PROCEDURE

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

Ginger exosomes plus curcumin

Study mixture will be taken PO daily times 28 days Sigmoidoscopy and biopsy, blood work, quality of life questionnaire

Group Type: ACTIVE_COMPARATOR

Sigmoidoscopy and biopsy, blood work

Intervention Type: PROCEDURE

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

Interventions

Sigmoidoscopy and biopsy, blood work

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

Intervention Type: PROCEDURE

Other Intervention Names

Inflammatory Bowel Disease Questionnaire

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Susan Galandiuk

Principal Investigator and Director, Division of Colorectal Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Galandiuk, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville

Louisville, Kentucky, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 27318094 (View on PubMed)

Other Identifiers

15.0872

Identifier Type: -

Identifier Source: org_study_id