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

NCT04879810 | Completed

• 1 other identifier: 15.0872
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Change in inflammation on Colonoscopy

  Decrease in inflammatory cells in the biopsy after treatment versus before treatment.

  30 days

Secondary Outcomes (1)

• Change in Subjective symptoms

  30 days

Study Arms (3)

Ginger exosomes

ACTIVE COMPARATOR

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

Curcumin

ACTIVE COMPARATOR

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

Ginger exosomes plus curcumin

ACTIVE COMPARATOR

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

Interventions

Sigmoidoscopy and biopsy, blood work PROCEDURE

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

Also known as: Inflammatory Bowel Disease Questionnaire

Curcumin; Ginger exosomes; Ginger exosomes plus curcumin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40292, United States

Location

Related Publications (1)

• 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.

  PMID: 27318094 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Sigmoidoscopy; Biopsy

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Colonoscopy; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques

Study Officials

• Susan Galandiuk, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Director, Division of Colorectal Surgery

Model Details: three Arms: 1. Ginger exosomes;2. Curcumin; 3. Ginger exosomes plus curcumin, Each PO daily times 28 days. All subjects will receive active treatment.

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: May 10, 2021
• Study Start: March 1, 2018
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)