Anthocyanin Rich Extract (ACRE) in Patients With Ulcerative Colitis

NCT04000139 | Completed Phase 2

• 1 other identifier: ACRE
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

Brief Summary

This study evaluates the efficacy and safety of a bilberry derived anthocyanin-rich extract in patients with ulcerative colitis. Two thirds of participants will receive the anthocyanin-rich extract, while one third will receive placebo, for 8 weeks of treatment.

Conditions

Ulcerative Colitis

Keywords

bilberry; anthocyanin; anthocyanin-rich extract; ulcerative colitis

Outcome Measures

Primary Outcomes (1)

• Clinical response at week 8

  Proportion of patients with clinical response at week 8 where clinical response is defined as the reduction of total mayo score ≥ 3 points

  8 weeks

Secondary Outcomes (13)

• Clinical remission at week 8

  8 weeks

• Rectal bleeding

  8 weeks

• Stool frequency

  8 weeks

• Endoscopic remission

  8 weeks

• Histological remission

  8 weeks

Study Arms (2)

Standardized anthocyanin rich extract

ACTIVE COMPARATOR

3 doses of 2x 500mg in capsules daily

Drug: Standardized anthocyanin-rich extract

Placebo

PLACEBO COMPARATOR

3 doses of 2x 500mg in capsules daily

Drug: Placebo

Interventions

Standardized anthocyanin-rich extract DRUG

3g of anthocyanin-rich extract taken daily as: 3 doses of 2x 500mg. Treatment duration 56 days (8 weeks).

Standardized anthocyanin rich extract

Placebo DRUG

3g of placebo taken daily as: 3 doses of 2x 500mg. Treatment duration 56 days (8 weeks).

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female ≥ 18 years of age
• Established diagnosis of UC, with minimum time from diagnosis of ≥3 months
• Moderately at least left sided UC (disease should extend 15 cm or more above the anal verge). Disease severity determined by a Modified Mayo score of 6 to 12 with an endoscopic sub score ≥2 assessed by central reading of endoscopy performed at screening visit and no other individual sub score \<1 (see 9.8.2 for more detailed information)
• Current oral or rectal 5-ASA/SP use or a history of oral or rectal 5-ASA/SP use
• Current steroids use or history of steroids dependency, refractory, or intolerance, including no steroids treatment due to earlier side-effects (only one of the steroids criteria have to be fulfilled, see definition in European Crohn´s and Colitis organization (ECCO) guidelines)
• One of the following points must be fulfilled:
• Intolerance to oral 5-ASAs or azathioprine OR
• Active disease despite a thiopurine (adequately dosed according to treatment guidelines, such as 2-3 mg/kg for azathioprine) or methotrexate administered for at least 12 weeks.
• Allowed to receive a therapeutic dose of following UC drugs during the study:
• Oral steroids therapy (≤30 mg prednisone or equivalent/daily) providing that the dose has been stable for 2 weeks prior Baseline
• Oral or rectal MMX Budesonide therapy (9mg/daily) initiated and a stable dose at least 2 months before Baseline
• Oral or rectal 5-ASA/SP compounds, providing that the dose has been stable for 2 months prior to Baseline and initiated at least 8 weeks before screening.
• AZA/6-MP providing that the dose has been stable for 8 weeks prior to Baseline and been initiated at least 2 months before screening
• TNF inhibitors (Infliximab, Adalimumab or Golimumab) are allowed, providing that the dose is stable for at least 2 months prior to baseline and during the study treatment period
• Vedolizumab and Tofacitinib is allowed providing that the dose is stable for at least 2 months prior to baseline and during the study treatment period

You may not qualify if:

• Suspicion of differential diagnosis such as; Crohn's enterocolitis, ischaemic colitis, radiation colitis, indeterminate colitis, infectious colitis, diverticular disease, associated colitis, microscopic colitis, massive pseudopolyposis or non-passable stenosis
• Acute fulminant UC and/or signs of systemic toxicity
• UC limited to the rectum (disease which extends \<15 cm above the anal verge)
• History of malignancy, except for:
• Treated (cured) basal cell or squamous cell in situ carcinoma
• Treated (cured) cervical intraepithelial neoplasia or
• carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years prior to the screening visit
• History or presence of any clinically significant disorder that, in opinion of the investigator, could impact on patient's possibility to adhere to the protocol and protocol procedures or would confound the study result or compromise patient safety
• Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs) within two weeks prior to screening (one short treatment regime for antibiotics and occasional use of NSAIDS are allowed)
• Serious active infection
• Gastrointestinal infections including positive Clostridium difficile stool assay
• Currently receiving parenteral nutrition or blood transfusions
• Females who are lactating or have a positive serum pregnancy test during the screening period
• Concurrent participation in another clinical study with investigational therapy or previous use of investigational therapy within 5 half-lives and within at least 30 days after last treatment of the experimental product prior to enrolment
• Subjects who have been treated with

Sponsors & Collaborators

• University of Zurich: lead
• Swiss National Science Foundation: collaborator
• The Broad Foundation: collaborator

Study Sites (6)

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Gastroenterologische Praxis Balsiger, Seibold & Partner

Bern, 3012, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

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

Study Officials

• Gerhard Rogler, Prof. Dr. med. Dr. phil.

  Universitätsspital Zürich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized into two treatment arms, active ingredient or placebo with the ratio 2:1.

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 27, 2019
• Study Start: April 1, 2019
• Primary Completion: March 11, 2021
• Study Completion: March 11, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (6)