Curcumin in Pediatric Ulcerative Colitis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02277223 |
Recruitment Status :
Recruiting
First Posted : October 28, 2014
Last Update Posted : March 19, 2020
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Condition or disease | Intervention/treatment | Phase |
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Ulcerative Colitis | Dietary Supplement: Curcumin Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Care Provider) |
Primary Purpose: | Treatment |
Official Title: | Curcumin for Induction and Maintenance Therapy in Pediatric Ulcerative Colitis |
Actual Study Start Date : | March 1, 2020 |
Estimated Primary Completion Date : | July 31, 2022 |
Estimated Study Completion Date : | December 31, 2022 |

Arm | Intervention/treatment |
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Experimental: Interventional
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
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Dietary Supplement: Curcumin
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. Other Name: Tumeric |
Placebo Comparator: Control
In addition to induction and maintenance therapy, patients will receive matched oral placebo capsules for induction and maintenance (Bara Herbs Inc), twice daily.
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Drug: 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. Other Name: Matched placebo |
- A change in disease activity, defined by PUCAI at 2 weeks and 6 months [ Time Frame: 6 months ]
- 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 ]

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Ages Eligible for Study: | 6 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
- 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.
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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.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277223
Contact: Amit Assa, MD | 9723543522211 | dr.amit.assa@gmail.com |
Israel | |
Schneider Medical Center | Recruiting |
Petach Tikva, Israel, 4259000 | |
Contact: Amit Assa +972543522211 dr.amit.assa@gmail.com |
Principal Investigator: | Amit Assa, MD | Schneider Children's Medical Center |
Responsible Party: | Amit Assa, Pediatric Gastroenterologist, Schneider Children's Medical Center, Israel |
ClinicalTrials.gov Identifier: | NCT02277223 |
Other Study ID Numbers: |
PUCC 1 |
First Posted: | October 28, 2014 Key Record Dates |
Last Update Posted: | March 19, 2020 |
Last Verified: | March 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases Curcumin |
Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |