Irritable Bowel DiseaseNCT04879810
Plant Exosomes +/- Curcumin to Abrogate Symptoms of Inflammatory Bowel Disease
A study testing Sigmoidoscopy and biopsy, blood work in people with Irritable Bowel Disease, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Disease
- What is being tested?
- Sigmoidoscopy and biopsy, blood work
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 2 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a confirmed diagnosis of IBD (either CD or UC) with moderate disease activity.)
- Ability to independently care for oneself
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40292
About this study
Official title: 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.
Read the 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
- Being tested
- Sigmoidoscopy and biopsy, blood work
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sigmoidoscopy and biopsy, blood workProcedure or surgery
Also called Inflammatory Bowel Disease Questionnaire
Flexible tube up lower colon, blood draws, quality of life questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Ginger exosomes | Active comparator | Study mixture will be taken PO daily times 28 days Sigmoidoscopy and biopsy, blood work, quality of life questionnaire Receives: 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 Receives: 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 Receives: Procedure: Sigmoidoscopy and biopsy, blood work |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammation on Colonoscopy
Decrease in inflammatory cells in the biopsy after treatment versus before treatment.
Measured: 30 days
Secondary outcomes (1)
Change in Subjective symptoms
Questionnaire reporting of decrease in subjective symptoms.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start1 Mar 2018
- Primary completion2 Aug 2022
- Study completion2 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Galandiuk, University of Louisville
- Investigators
- Susan Galandiuk, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879810
- Sponsor's protocol ID
- 15.0872
- Status last verified
- Nov 2022
- First submitted
- 6 Jun 2018
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27318094
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Clinical Trial Investigating the Ability of Plant Exosomes +/- Curcumin to Abrogate Symptoms of Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT04879810
- Acronym / sponsor ID
- 15.0872
- Conditions
- Irritable Bowel Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 2 Aug 2022 (actual)
- Study completion
- 2 Aug 2022 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ginger exosomes | Active comparator | Procedure: Sigmoidoscopy and biopsy, blood workStudy mixture will be taken PO daily times 28 days Sigmoidoscopy and biopsy, blood work, quality of life questionnaire |
| Curcumin | Active comparator | Procedure: Sigmoidoscopy and biopsy, blood workStudy mixture will be taken PO daily times 28 days Sigmoidoscopy and biopsy, blood work, quality of life questionnaire |
| Ginger exosomes plus curcumin | Active comparator | Procedure: Sigmoidoscopy and biopsy, blood workStudy mixture will be taken PO daily times 28 days Sigmoidoscopy and biopsy, blood work, quality of life questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must have a confirmed diagnosis of IBD (either CD or UC) with moderate disease activity.)
- Ability to independently care for oneself
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sigmoidoscopy and biopsy, blood workAlso: Inflammatory Bowel Disease QuestionnaireFlexible tube up lower colon, blood draws, quality of life questionnaires | Procedure or surgery | Curcumin, Ginger exosomes, Ginger exosomes plus curcumin |
Primary outcome
Change in inflammation on Colonoscopy
Time frame: 30 days
Decrease in inflammatory cells in the biopsy after treatment versus before treatment.
1 secondary outcome
Change in Subjective symptoms
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 27318094Zhang 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.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Disease
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Galandiuk, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sigmoidoscopy and biopsy, blood work in people with Irritable Bowel Disease, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in inflammation on Colonoscopy (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04879810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.