Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
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.
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Zurich|
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|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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
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.