Anthocyanin Rich Extract (ACRE) in Patients With Ulcerative Colitis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female ≥ 18 years of age 2. Established diagnosis of UC, with minimum time from diagnosis of ≥3 months 3. 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) 4. Current oral or rectal 5-ASA/SP use or a history of oral or rectal 5-ASA/SP use 5. 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) 6. One of the following points must be fulfilled: 1. Active disease despite induction therapy with 5-ASA agents where adequate therapy is considered with an oral 5-ASA (mesalamine 2- 4.8 g/day, sulfasalazine 4-6 g/day) administered for at least 2 weeks. Topical treatment with 5-ASA may have been attempted but this is not a prerequisite for inclusion in the study OR 2. Intolerance to oral 5-ASAs or azathioprine OR 3. 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. 7. Allowed to receive a therapeutic dose of following UC drugs during the study: 1. Oral steroids therapy (≤30 mg prednisone or equivalent/daily) providing that the dose has been stable for 2 weeks prior Baseline 2. Oral or rectal MMX Budesonide therapy (9mg/daily) initiated and a stable dose at least 2 months before Baseline 3. 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. 4. 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 5. 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 6. 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 8. Ability to understand the treatment, willingness to comply with all study requirements and ability to provide informed consent

Exclusion Criteria:

Subjects fulfilling any of the following criteria are not eligible for inclusion in this study: 1. 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 2. Acute fulminant UC and/or signs of systemic toxicity 3. UC limited to the rectum (disease which extends <15 cm above the anal verge) 4. History of malignancy, except for: 1. Treated (cured) basal cell or squamous cell in situ carcinoma 2. Treated (cured) cervical intraepithelial neoplasia or 3. carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years prior to the screening visit 5. 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 6. 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) 7. Serious active infection 8. Gastrointestinal infections including positive Clostridium difficile stool assay 9. Currently receiving parenteral nutrition or blood transfusions 10. Females who are lactating or have a positive serum pregnancy test during the screening period 11. 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 12. Subjects who have been treated with a. A dose of ≥ 1 mg per kg body weight prednisone or ≥30mg/d in the last 4 weeks prior to randomization. 13. Ongoing treatment with cyclosporine or tacrolimus. Eligible subjects must have stopped cyclosporine and/or tacrolimus at least 4 weeks and antibiotics at least 1 week prior to randomization. 14. known history of alcohol abuse, chronic liver or biliary disease 15. Repeated and confirmed laboratory findings showing: 1. total bilirubin greater than 2 x upper limit of the normal range (ULN) unless in context of Gilbert's syndrome 2. alkaline phosphatase (AP) greater than 2 x ULN 3. ALT (SGPT) greater than 2 x ULN 4. serum creatinine greater than 2 X ULN 5. total white blood cell count (WBC) outside the range of 3,000
  • - 15,000 /μL.
Subjects with mild leukocytosis (WBC not higher than 15,000 /μL) may be eligible, especially if the elevated WBC, according to the Investigator, is attributable to corticosteroid therapy and other causes such as hematological or infectious diseases can be excluded. 6. platelet count <100,000/μL 7. Hemoglobin less 8 g/dL and/or other signs of severe anemia. 16. History or presence of a significant renal disease. 17. Significant illness within the two weeks prior to dosing or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study. 18. Current history of active systemic bacterial, viral or fungal infections 19. Presence or history of underlying metabolic, endocrine, hematologic, pulmonary, cardiac, blood, renal, hepatic, infectious, psychiatric or any medically unstable condition, as assessed by the primary treating physician which, in the opinion of the investigator, would place the subject at unacceptable risk for participation in the study. 20. Known allergies to bilberries or any other AC containing fruits 21. Planned diet change, any severe or new dietary restrictions

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04000139
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Zurich
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gerhard Rogler, Prof. Dr. med. Dr. phil.
Principal Investigator Affiliation Universitätsspital Zürich
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOtherOther
Overall Status Recruiting
Countries Switzerland
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Additional Details

For anthocyanins (ACs), a wide range of protective biological effects have been described, such as anti-oxidative, anti-carcinogenic, anti-microbial and anti-inflammatory activities. Various research groups could identify a beneficial effect of ACs in IBD and intestinal inflammation. A total of 112 subjects will be randomized. Subjects will be screened for eligibility between 0 and 28 days prior to baseline visit. At the baseline visit, subjects with moderate to severe ulcerative colitis (Mayo score ≥6) and fulfilling all inclusion/exclusion criteria will be randomized into two treatment arms (ACRE or placebo). Total duration of drug product administration will be 8 weeks (56 days) followed by a follow-up phase of 30 days.

Arms & Interventions

Arms

Active Comparator: Standardized anthocyanin rich extract

3 doses of 2x 500mg in capsules daily

Placebo Comparator: Placebo

3 doses of 2x 500mg in capsules daily

Interventions

Drug: - Standardized anthocyanin-rich extract

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

Drug: - Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Universitätsspital Basel, Basel, Switzerland

Status

Recruiting

Address

Universitätsspital Basel

Basel, , 4031

Site Contact

Petr Hruz, PD Dr. med.

petr.hruz@clarunis.ch

+41 61 777 74 19

Inselspital Bern, Bern, Switzerland

Status

Recruiting

Address

Inselspital Bern

Bern, , 3010

Site Contact

Pascal Juillerat, PD Dr. med.

pascal.juillerat@insel.ch

+41 31 632 59 00

Bern, Switzerland

Status

Recruiting

Address

Gastroenterologische Praxis Balsiger, Seibold & Partner

Bern, , 3012

Site Contact

Frank Seibold, Prof. Dr. med.

frank.seibold@magendarmsuisse.ch

+41 31 302 32 34

Hôpitaux Universitaires Genève, Geneva, Switzerland

Status

Not yet recruiting

Address

Hôpitaux Universitaires Genève

Geneva, , 1211

Site Contact

Sophie Restellini, Dr. med.

sophie.restellini@hcuge.ch

+41 22 372 93 55

Gastroentérologie Beaulieu SA, Lausanne, Switzerland

Status

Recruiting

Address

Gastroentérologie Beaulieu SA

Lausanne, , 1004

Site Contact

Michel Maillard, PD Dr. med.

mmaillard@gesb.ch

+41 21 644 30 50

Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland

Status

Recruiting

Address

Centre Hospitalier Universitaire Vaudois

Lausanne, , 1011

Site Contact

Alain Schöpfer, Prof. Dr. med.

alain.schoepfer@chuv.ch

+41 21 314 7158

Kantonsspital St. Gallen, Saint Gallen, Switzerland

Status

Recruiting

Address

Kantonsspital St. Gallen

Saint Gallen, , 9007

Site Contact

Stephan Brand, Prof. Dr. med.

stephan.brand@kssg.ch

+41 71 494 30 40

Universitätsspital Zürich, Zürich, Switzerland

Status

Recruiting

Address

Universitätsspital Zürich

Zürich, , 8091

Site Contact

Luc Biedermann, PD Dr. med.

luc.biedermann@usz.ch

+41 44 255 85 48

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to our Terms, Conditions & Privacy.