Ulcerative ColitisPhase 3NCT02277223
Curcumin in Pediatric Ulcerative Colitis
A Phase 3 study testing Curcumin in people with Ulcerative Colitis, run by Schneider Children's Medical Center, Israel at 1 site in Israel.
Trial summary
Background: Curcumin in an active phytochemical substance, used as part of the human diet, that has anti-inflammatory and anti-oxidative properties which were demonstrated in multiple experimental models of colitis including a positive effect on maintenance of remission in adult ulcerative colitis (UC) patients. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2020to 31 Dec 2022
- Phase
- Phase 3
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of UC, established by the presence of accepted clinical, radiologic, endoscopic and histologic criteria.
- Age: 6 - 18 years (inclusive).
- PUCAI 10-65 at enrollment
- Negative stool culture, parasites and clostridium toxin
- Ability and acceptance to participate in the study and follow study procedures, as evidenced by a parent/legal guardian signing a written informed consent and the child providing assent.
Who cannot join
- Acute severe UC (PUCAI>65 points) requiring IV corticosteroids.
- History of two relapses or more on 5-ASA treatment.
- Pregnancy
- Sepsis or active bacterial infection
- Fever >38.5 degrees.
- Patients whose disease is confined to the rectum (i.e. proctitis).
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- Patients with crohn's colitis or with IBD type unclassified (IBD-U) according to Montreal classification.
- Rectal therapies (suppositories, foams, enemas etc) of all kind are allowed if the dose and frequency has remained stable during the previous 14 days prior to the screening visit.
- Known allergy to 5ASA, salicylates, or aminosalicylates.
- History of recurrent pancreatitis.
- Existence of current renal disease, or a screening blood urea nitrogen (BUN) or creatinine value that is > 1.5 times the upper limit of the age appropriate normal.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Curcumin for Induction and Maintenance Therapy in Pediatric Ulcerative Colitis
Background: Curcumin in an active phytochemical substance, used as part of the human diet, that has anti-inflammatory and anti-oxidative properties which were demonstrated in multiple experimental models of colitis including a positive effect on maintenance of remission in adult ulcerative colitis (UC) patients. Objectives: To examine the effect of curcumin as complementary medication in induction and maintenance therapy in pediatric patients with mild to moderate ulcerative colitis. Design: A prospective, randomized, placebo-controlled study. Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 18 years who are diagnosed with mild to moderate UC and are planned to receive either 5-ASA or corticosteroids induction treatment. Main outcome measures: Disease activity defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 2 weeks and 6 months. Secondary outcome measures: Effect of curcumin treatment on serum inflammatory markers, calprotectin and fecal microbiota. Data analysis: Data will be collected and analyzed using SPSS (version 21.0, SPSS, Inc., Chicago, IL, USA). Fisher's exact test will be used to explore univariate associations between primary outcomes and categorical variables. Associations of continues variables with primary outcome measures will be examined using ANOVA with repeated measures. P-values <0.05 will be considered significant.
Read the detailed description
Clinical efficacy of induction and maintenance medications in pediatric UC is limited with a cumulative long-term risk of 20%-30% for colectomy. Remission rates following induction with corticosteroids and 5-amino-salicylic acid (5-ASA) range from 20% to 50%. 5-ASA is still regarded as first line induction and maintenance therapy for mild to moderate UC in both children and adults. 5-ASA is also indicated for maintenance therapy following successful induction with corticosteroids for moderate to severe disease. Still, steroid free clinical remission at 1 year under 5-ASA maintenance therapy is reported to range from 40% to 50%. Management of recurrent flares while taking 5-ASA medications involves repeated courses of corticosteroids and changing therapeutic regimes to include more potent medications such as thiopurines which carry an increased risk for significant adverse effects. Hence, improving efficacy of induction and maintenance treatment is of critical importance. Curcumin, an active phytochemical substance with anti-inflammatory properties was studied extensively in-vitro and in experimental models of colitis. In the only randomized controlled trial, performed in adults with quiescent disease, curcumin was shown to be an effective concomitant treatment (along with 5-ASA) for maintenance of remission. Therefore, our aim is to assess the efficacy of concomitant curcumin maintenance therapy for induction and maintenance therapy in pediatric UC patients with mild to moderate in a prospective randomized, placebo controlled trial. We hope that this study will further contribute to the understanding of the potential benefits of curcumin in pediatric UC patients.
- Conditions
- Ulcerative Colitis
- Being tested
- Curcumin, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDietary supplement
Also called Tumeric
Eligible patients will be randomized to either intervention of placebo groups. Randomization will be performed separately for patients receiving corticosteroids for induction in-order to ensure similar heterogeneity within groups. Induction: oral prednisone 1mg/kg up to 40 mg once daily for 2 weeks and then tapered down by 5 mg per week or 5-ASA 75 mg/kg/day divided to two doses. Maintenance: 5-ASA 75 mg/kg/day divided to two doses.
Patients receiving corticosteroids for induction, whose PUCAI is >35 points at 2 weeks will be regarded as treatment failure. Patients receiving 5-ASA for induction with "induction treatment failure" will be re-randomized to receive oral corticosteroids induction with or without curcumin.
PlaceboDrug
Also called Matched placebo
Eligible patients will be randomized to either intervention of placebo groups. Randomization will be performed separately for patients receiving corticosteroids for induction in-order to ensure similar heterogeneity within groups. Induction: oral prednisone 1mg/kg up to 40 mg once daily for 2 weeks and then tapered down by 5 mg per week or 5-ASA 75 mg/kg/day divided to two doses. Maintenance: 5-ASA 75 mg/kg/day divided to two doses.
Patients receiving corticosteroids for induction, whose PUCAI is >35 points at 2 weeks will be regarded as treatment failure. Patients receiving 5-ASA for induction with "induction treatment failure" will be re-randomized to receive oral corticosteroids induction with or without curcumin.
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | In addition to induction therapy, patients will receive oral capsules of curcumin (Bara Herbs Inc): Weight<20kg: 1 gram, twice daily, 20-30 kg: 1.5 grams twice daily, weight>30kg: 2 grams twice daily. For Maintenance, in addition to oral 5-ASA maintenance treatment, responding patients will receive oral capsules of curcumin (Bara Herbs Inc): Weight<30kg: 500 milligram, twice daily, weight>30kg: 1 gram twice daily Receives: Dietary Supplement: Curcumin |
| Control | Placebo comparator | In addition to induction and maintenance therapy, patients will receive matched oral placebo capsules for induction and maintenance (Bara Herbs Inc), twice daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A change in disease activity, defined by PUCAI at 2 weeks and 6 months
Measured: 6 months
Secondary outcomes (4)
Sustained clinical remission, 2 weeks and 6 months
Measured: 6 months
Medication associated adverse events
Measured: 6 months
Time to relapse
Measured: 6 months
The need for further medical interventions (e.g topical 5-ASA) during the maintenance phase
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study start1 Mar 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Difficulty to enroll patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schneider Children's Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amit Assa, Schneider Children's Medical Center, Israel
- Investigators
- Amit Assa, MD, Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277223
- Sponsor's protocol ID
- PUCC 1
- Status last verified
- Sep 2021
- First submitted
- 25 Oct 2014
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin for Induction and Maintenance Therapy in Pediatric Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02277223
- Acronym / sponsor ID
- PUCC 1
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulty to enroll patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Schneider Children's Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 Oct 2014 (estimated)
- 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.
Background: Curcumin in an active phytochemical substance, used as part of the human diet, that has anti-inflammatory and anti-oxidative properties which were demonstrated in multiple experimental models of colitis including a positive effect on maintenance of remission in adult ulcerative colitis (UC) patients. Objectives: To examine the effect of curcumin as complementary medication in induction and maintenance therapy in pediatric patients with mild to moderate ulcerative colitis. Design: A prospective, randomized, placebo-controlled study. Setting: Pediatric gastroenterology centers. Participants: Children 6 year to 18 years who are diagnosed with mild to moderate UC and are planned to receive either 5-ASA or corticosteroids induction treatment. Main outcome measures: Disease activity defined by the Pediatric Ulcerative Colitis Activity Index (PUCAI) at 2 weeks and 6 months. Secondary outcome measures: Effect of curcumin treatment on serum inflammatory markers, calprotectin and fecal microbiota. Data analysis: Data will be collected and analyzed using SPSS (version 21.0, SPSS, Inc., Chicago, IL, USA). Fisher's exact test will be used to explore univariate associations between primary outcomes and categorical variables. Associations of continues variables with primary outcome measures will be examined using ANOVA with repeated measures. P-values <0.05 will be considered significant.
Detailed description
Clinical efficacy of induction and maintenance medications in pediatric UC is limited with a cumulative long-term risk of 20%-30% for colectomy. Remission rates following induction with corticosteroids and 5-amino-salicylic acid (5-ASA) range from 20% to 50%. 5-ASA is still regarded as first line induction and maintenance therapy for mild to moderate UC in both children and adults. 5-ASA is also indicated for maintenance therapy following successful induction with corticosteroids for moderate to severe disease. Still, steroid free clinical remission at 1 year under 5-ASA maintenance therapy is reported to range from 40% to 50%. Management of recurrent flares while taking 5-ASA medications involves repeated courses of corticosteroids and changing therapeutic regimes to include more potent medications such as thiopurines which carry an increased risk for significant adverse effects. Hence, improving efficacy of induction and maintenance treatment is of critical importance. Curcumin, an active phytochemical substance with anti-inflammatory properties was studied extensively in-vitro and in experimental models of colitis. In the only randomized controlled trial, performed in adults with quiescent disease, curcumin was shown to be an effective concomitant treatment (along with 5-ASA) for maintenance of remission. Therefore, our aim is to assess the efficacy of concomitant curcumin maintenance therapy for induction and maintenance therapy in pediatric UC patients with mild to moderate in a prospective randomized, placebo controlled trial. We hope that this study will further contribute to the understanding of the potential benefits of curcumin in pediatric UC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Dietary Supplement: CurcuminIn addition to induction therapy, patients will receive oral capsules of curcumin (Bara Herbs Inc): Weight<20kg: 1 gram, twice daily, 20-30 kg: 1.5 grams twice daily, weight>30kg: 2 grams twice daily. For Maintenance, in addition to oral 5-ASA maintenance treatment, responding patients will receive oral capsules of curcumin (Bara Herbs Inc): Weight<30kg: 500 milligram, twice daily, weight>30kg: 1 gram twice daily |
| Control | Placebo comparator | Drug: PlaceboIn addition to induction and maintenance therapy, patients will receive matched oral placebo capsules for induction and maintenance (Bara Herbs Inc), twice daily. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of UC, established by the presence of accepted clinical, radiologic, endoscopic and histologic criteria.
- Age: 6 - 18 years (inclusive).
- PUCAI 10-65 at enrollment
- Negative stool culture, parasites and clostridium toxin
- Ability and acceptance to participate in the study and follow study procedures, as evidenced by a parent/legal guardian signing a written informed consent and the child providing assent.
Key exclusion criteria (12 listed)
- Acute severe UC (PUCAI>65 points) requiring IV corticosteroids.
- History of two relapses or more on 5-ASA treatment.
- Pregnancy
- Sepsis or active bacterial infection
- Fever >38.5 degrees.
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 |
|---|---|---|
| CurcuminAlso: TumericEligible patients will be randomized to either intervention of placebo groups. Randomization will be performed separately for patients receiving corticosteroids for induction in-order to ensure similar heterogeneity within groups. Induction: oral prednisone 1mg/kg up to 40 mg once daily for 2 weeks and then tapered down by 5 mg per week or 5-ASA 75 mg/kg/day divided to two doses. Maintenance: 5-ASA 75 mg/kg/day divided to two doses. Patients receiving corticosteroids for induction, whose PUCAI is >35 points at 2 weeks will be regarded as treatment failure. Patients receiving 5-ASA for induction with "induction treatment failure" will be re-randomized to receive oral corticosteroids induction with or without curcumin. | Dietary supplement | Interventional |
| PlaceboAlso: Matched placeboEligible patients will be randomized to either intervention of placebo groups. Randomization will be performed separately for patients receiving corticosteroids for induction in-order to ensure similar heterogeneity within groups. Induction: oral prednisone 1mg/kg up to 40 mg once daily for 2 weeks and then tapered down by 5 mg per week or 5-ASA 75 mg/kg/day divided to two doses. Maintenance: 5-ASA 75 mg/kg/day divided to two doses. Patients receiving corticosteroids for induction, whose PUCAI is >35 points at 2 weeks will be regarded as treatment failure. Patients receiving 5-ASA for induction with "induction treatment failure" will be re-randomized to receive oral corticosteroids induction with or without curcumin. | Drug | Control |
Primary outcome
A change in disease activity, defined by PUCAI at 2 weeks and 6 months
Time frame: 6 months
4 secondary outcomes
Sustained clinical remission, 2 weeks and 6 months
Time frame: 6 months
Medication associated adverse events
Time frame: 6 months
Time to relapse
Time frame: 6 months
The need for further medical interventions (e.g topical 5-ASA) during the maintenance phase
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
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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.
Amit Assa, MD principal investigator
Schneider Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Curcumin in people with Ulcerative Colitis, run by Schneider Children's Medical Center, Israel 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 5 inclusion and 12 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: withdrawn, as of the sponsor's last update on 1 Oct 2021. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
A change in disease activity, defined by PUCAI at 2 weeks and 6 months (time frame: 6 months). 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 1 Oct 2021.