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HF2 Therapy in the Treatment of Active Ulcerative Colitis

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. Read our disclaimer for details. Identifier: NCT03720002
Recruitment Status : Completed
First Posted : October 25, 2018
Last Update Posted : April 14, 2023
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:

This is a phase I-II study with the herbal formulation (HF2) for treatment of active ulcerative colitis

This will be a two-stage study:

Stage 1 will comprise an open label single arm exploratory study of 10 active ulcerative colitis (UC) patients investigating oral HF2 therapy for induction of remission in outpatients with active UC. Active disease is defined as (SCCAI) score ≥5 and a score of ≥2 in the modified Mayo endoscopic sub-score. Clinical remission is defined as a SCCAI score of ≤2 The patients will receive HF2 therapy for 4 weeks. Stage 2: If clinical response (defined as a drop of ≥3 points of the SCCAI score ) is achieved in ≥ 3 patients and no significant safety signals will emerge, the investigators will proceed to a prospective pilot randomized placebo-controlled study. Patients will be randomized into one of two arms: HF2 once daily or placebo formulation (2:1 proportion) for 8 weeks.

The primary outcome for stage 2 is a co-primary outcome of clinical response (reduction in SCCAI of ≤3 OR achievement of clinical remission defined as SCCAI ≤2) coupled with an objective evidence of response (Mayo score improvement of ≥1 or 50% FcAL reduction) at week 8.

Patients clinically responding at week 8, will be eligible to continue in an 8-weeks extension study to receive either placebo or 1.5gr/day curcumin alone until week 16, as per their original allocation. Exploratory analysis of outcomes for the extension study will include the percentage of patients in clinical remission (SCCAI≤2) and the percentage of patients who maintained clinical response (reduction in SCCAI of ≥3 point compared to week 0).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Dietary Supplement: HF2 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After an initial open-label run-in (if successful) the patients will be randomized to receive HF2 or placebo (2:1 allocation)
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: participant/care provider/investigator blinded
Primary Purpose: Treatment
Official Title: HF2 Therapy in the Treatment of Active Ulcerative Colitis:
Actual Study Start Date : May 29, 2019
Actual Primary Completion Date : February 1, 2023
Actual Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active treatment
Will receive HF2 add-on
Dietary Supplement: HF2

Placebo Comparator: Placebo
Will receive placebo
Dietary Supplement: HF2

Primary Outcome Measures :
  1. Stage I: Clinical remission [ Time Frame: week 4 ]
    achievement of remission in the symptoms of the disease (defined as Simple Clinical Colitis Activity Index -SCCAI score of ≤2)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Established diagnosis of UC
  • Age- 18-70
  • active UC defined by a Simple Clinical Colitis Activity Index (SCCAI) score ≥5 and a score of ≥2 in the modified Mayo endoscopic sub-score.
  • Stable medication dose or if the patient has discontinued previous treatment :

for Infliximab or Vedolizumab - at least one month after patient received last dose; for Adalimumab, Golimumab, immunomodulator, corticosteroids, 5ASA - at least two weeks after patient received last dose.

Exclusion criteria:

  • non-controlled renal or liver disease, hypertension, cardiovascular disease, cerebrovascular disease, chronic pancreatitis, diabetes mellitus, gallstone disease, uncontrolled migraines or neurological disorders
  • significant laboratory abnormalities, including anemia with hemoglobin <10, leucopenia , thrombocytopenia , abnormal coagulation tests , or elevation of liver or kidney function tests above the normal values.
  • active infection, sepsis or pneumonia.
  • pregnancy/nursing
  • known allergy to the compound

Information from the National Library of Medicine

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 identifier (NCT number): NCT03720002

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Evaggelismos medical center
Athens, Greece
Sheba Medical Center
Ramat Gan, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
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Responsible Party: Sheba Medical Center Identifier: NCT03720002    
Other Study ID Numbers: SHEBA-17-4232-UK-CTIL
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: April 14, 2023
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases