HF2 Therapy in the Treatment of Active Ulcerative Colitis

NCT03720002 | Completed Phase 1

• 1 other identifier: SHEBA-17-4232-UK-CTIL
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 2

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).

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Stage I: Clinical remission

  achievement of remission in the symptoms of the disease (defined as Simple Clinical Colitis Activity Index -SCCAI score of ≤2)

  week 4

Study Arms (2)

Active treatment

EXPERIMENTAL

Will receive HF2 add-on

Dietary Supplement: HF2

Placebo

PLACEBO COMPARATOR

Will receive placebo

Dietary Supplement: HF2

Interventions

HF2 DIETARY_SUPPLEMENT

placebo

Active treatment; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (2)

Evaggelismos medical center

Athens, Greece

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Related Publications (1)

• Ben-Horin S, Salomon N, Karampekos G, Viazis N, Lahat A, Ungar B, Eliakim R, Kuperstein R, Kriger-Sharabi O, Reiss-Mintz H, Yanai H, Dotan I, Zittan E, Maharshak N, Hirsch A, Weitman M, Mantzaris GJ, Kopylov U. Curcumin-QingDai Combination for Patients With Active Ulcerative Colitis: A Randomized, Double-Blinded, Placebo-Controlled Trial. Clin Gastroenterol Hepatol. 2024 Feb;22(2):347-356.e6. doi: 10.1016/j.cgh.2023.05.023. Epub 2023 Jun 9.

  PMID: 37302449 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: participant/care provider/investigator blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: After an initial open-label run-in (if successful) the patients will be randomized to receive HF2 or placebo (2:1 allocation)

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: October 25, 2018
• Study Start: May 29, 2019
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: April 14, 2023

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); GR (1)