Clinical trial NCT04879810: Plant Exosomes +/- Curcumin to Abrogate Symptoms of Inflammatory Bowel Disease
Official title: Pilot Clinical Trial Investigating the Ability of Plant Exosomes +/- Curcumin to Abrogate Symptoms of Inflammatory Bowel Disease (IBD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Disease
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three Arms: 1. Ginger exosomes;2. Curcumin; 3. Ginger exosomes plus curcumin, Each PO daily times 28 days. All subjects will receive active treatment.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in inflammation on Colonoscopy
timeFrame: 30 days
Secondary outcomes:
measure: Change in Subjective symptoms
timeFrame: 30 days
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Susan Galandiuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.