Inflammatory Bowel DiseasesNCT03500653
Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab
A study testing Curcumin in people with Inflammatory Bowel Diseases, run by Henit Yanai at 1 site in Israel.
Trial summary
Introduction: The pathogenesis of inflammatory bowel diseases (IBD) is characterized by dysregulation of the innate immune response it's associated with Th1, Th17 up-regulation, reflected by increased cytokine secretion including TNF-α. A main effective therapeutic interventions is blocking TNFα. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Curcumin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Jun 2020to Dec 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Established inflammatory bowel disease
- Age ≥18 years old
- At inclusion all patients must have a documented active colonic involvement based on either endoscopy or imaging:
- Commencing vedolizumab therapy according to the treating physician or on active therapy up to 6-weeks.
- Active luminal disease:
- CD- HBI ≥325, 26 UC- partial Mayo ≥227
- Evident active disease on endoscopy or imaging within 2-week from inclusion or elevated inflammatory markers at screening (CRP> 0.5 mg/dl, or fecal calprotectin>100 μgr/gr stool or ESR >40).
Who cannot join
- CD- isolated small bowel disease (L1) UC- proctitis (E1)
- Perianal disease
- Pregnancy
- Biliary obstruction
- Concomitant treatment with beta blockers, anti-coagulants, and norfloxacin (relative contra indications to curcumin therapy).
- Curcumin supplementations within the last 6 months.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center
Petah Tikva
Henit Yanai, MD
Tamar Pfefer Gic, MA
About this study
Introduction: The pathogenesis of inflammatory bowel diseases (IBD) is characterized by dysregulation of the innate immune response it's associated with Th1, Th17 up-regulation, reflected by increased cytokine secretion including TNF-α. A main effective therapeutic interventions is blocking TNFα. Vedolizumab, an anti integrin, is a new class of treatment designed to block trafficking of lymphocytes in the gut. Clinical trials and real life experience response rates at week 6 range between 30-45%. Curcumin suppresses NFκβ levels via alteration of TLR2/4 pathways lowering TNF-α upstream. Curcumin is safe and efficacious in inducing response and remission in mild-moderate Ulcerative colitis (UC) and maintaining remission when used as an add-on to 5ASA derivatives, only with strict adherence to treatment overtime.
Objectives: Facing the low rate of response to therapies in IBD, the need for new treatments and the use of combination strategies lead us to believe that combining vedolizumab and curcumin may have a synergistic effect and will enable optimal immunomodulation.
Read more
Hypothesis: Concomitant oral curcumin in IBD patients with colonic involvement will augment remission rates as well as clinical and biochemical response.
Type of research and methods of data collection: A randomized controlled trial in 84 adults with colonic IBD (UC and CD). Eligible patients are during vedolizumab induction, patients will randomized will be into curcumin or placebo. Data will managed by investigators.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Curcumin, Placebo
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
4 gr curcumin
PlaceboDietary supplement
4 gr placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | 4 gr Curcumin daily for 1 year in addition to vedolizumab 300 mg per infusion (standard of care) Receives: Dietary Supplement: Curcumin |
| Sham | Placebo comparator | 4 gr placebo daily for 1 year in addition to vedolizumab300 mg per infusion (standard of care) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission- Crohn's disease patients
Crohn's disease patients - disease activity indexe: Harvey Bradshow index (HBI) less that 3
Measured: 52 weeks
Clinical remission- ulcerative colitis patients
Disease activity index - partial Mayo score less than 2
Measured: 52 weeks
Secondary outcomes (4)
Disease response- Crohn's disease patients
Disease activity index- Harvey Bradshow index (HBI ) a drop of 3 points
Measured: 52 weeks
Disease response- ulcerative colitis patients
Disease activity index -partial Mayo score a drop of 2 points
Measured: 52 weeks
Biochemical remission
Fecal calprotectin less than 150 µg/gr
Measured: 52 weeks
Biochemical remission
C reactive protein (CRP) less thn 0.5 mg/dl
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start9 Jun 2020
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henit Yanai
- Sponsor type
- University, hospital or other
- Collaborators
- Shaare Zedek Medical Center
- Responsible party
- Sponsor-investigator, Henit Yanai, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500653
- Sponsor's protocol ID
- RMC-0290-17
- Status last verified
- Oct 2020
- First submitted
- 14 Jun 2017
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin Supplementation as an Add on Treatment for Patients With Inflammatory Bowel Diseases Treated With Vedolizumab
- ClinicalTrials.gov ID
- NCT03500653
- Acronym / sponsor ID
- RMC-0290-17
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Henit YanaiUniversity, hospital or other
- Collaborators
- Shaare Zedek Medical Center
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Apr 2018 (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.
Introduction: The pathogenesis of inflammatory bowel diseases (IBD) is characterized by dysregulation of the innate immune response it's associated with Th1, Th17 up-regulation, reflected by increased cytokine secretion including TNF-α. A main effective therapeutic interventions is blocking TNFα. Vedolizumab, an anti integrin, is a new class of treatment designed to block trafficking of lymphocytes in the gut. Clinical trials and real life experience response rates at week 6 range between 30-45%. Curcumin suppresses NFκβ levels via alteration of TLR2/4 pathways lowering TNF-α upstream. Curcumin is safe and efficacious in inducing response and remission in mild-moderate Ulcerative colitis (UC) and maintaining remission when used as an add-on to 5ASA derivatives, only with strict adherence to treatment overtime.
Objectives: Facing the low rate of response to therapies in IBD, the need for new treatments and the use of combination strategies lead us to believe that combining vedolizumab and curcumin may have a synergistic effect and will enable optimal immunomodulation.
Hypothesis: Concomitant oral curcumin in IBD patients with colonic involvement will augment remission rates as well as clinical and biochemical response.
Type of research and methods of data collection: A randomized controlled trial in 84 adults with colonic IBD (UC and CD). Eligible patients are during vedolizumab induction, patients will randomized will be into curcumin or placebo. Data will managed by investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Curcumin4 gr Curcumin daily for 1 year in addition to vedolizumab 300 mg per infusion (standard of care) |
| Sham | Placebo comparator | Dietary Supplement: Placebo4 gr placebo daily for 1 year in addition to vedolizumab300 mg per infusion (standard of care) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Established inflammatory bowel disease
- Age ≥18 years old
- At inclusion all patients must have a documented active colonic involvement based on either endoscopy or imaging:
- Commencing vedolizumab therapy according to the treating physician or on active therapy up to 6-weeks.
- Active luminal disease:
Key exclusion criteria (6 listed)
- CD- isolated small bowel disease (L1) UC- proctitis (E1)
- Perianal disease
- Pregnancy
- Biliary obstruction
- Concomitant treatment with beta blockers, anti-coagulants, and norfloxacin (relative contra indications to curcumin therapy).
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 |
|---|---|---|
| Curcumin4 gr curcumin | Dietary supplement | Active |
| Placebo4 gr placebo | Dietary supplement | Sham |
Primary outcome
Clinical remission- Crohn's disease patients
Time frame: 52 weeks
Crohn's disease patients - disease activity indexe: Harvey Bradshow index (HBI) less that 3
Clinical remission- ulcerative colitis patients
Time frame: 52 weeks
Disease activity index - partial Mayo score less than 2
4 secondary outcomes
Disease response- Crohn's disease patients
Time frame: 52 weeks
Disease response- ulcerative colitis patients
Time frame: 52 weeks
Biochemical remission
Time frame: 52 weeks
Biochemical remission
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Curcumin in people with Inflammatory Bowel Diseases, run by Henit Yanai at 1 site in Israel.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Oct 2020. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Henit Yanai, MD (+972-3977241 ext. 5, henitya@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission- Crohn's disease patients (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2020.