Monocultivar Coratina Extra Virgin Olive Oil in UC Patients

NCT03408847 | Unknown

• 1 other identifier: EVO-RCU-2017
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Epidemiological studies suggest that daily intake of fruits and vegetables high in polyphenols or the addition of olive oil containing many polyphenols is associated with a reduced risk of chronic diseases including cardiovascular, metabolic, neurodegenerative, and inflammatory bowel conditions. In vivo experiments demonstrated that the administration of a diet associated with daily intake of extra virgin olive oil (EVOO) reduces histological lesions and symptomatology in rats with a dextran sulfate sodium (DDS) induced colitis. A diet supplemented with hydroxytyrosol (a component of olive oil) showed a reduction of the inflammatory process at the inflamed colon of the rats.

Conditions

Ulcerative Colitis Chronic Mild

Keywords

Ulcerative colitis; UC; Extra virgin olive oil; Polyphenols

Outcome Measures

Primary Outcomes (1)

• Evaluation of the short-term clinical response

  Evaluation of the short-term clinical response rate in the 2 treatment groups

  12 weeks

Secondary Outcomes (4)

• Evaluation of the clinical remission

  12 weeks

• Evaluation of the endoscopic remission

  12 weeks

• Evaluation of markers of inflammation

  12 weeks

• Evaluation of adverse events

  12 weeks

Study Arms (2)

MC-EVOO in addition to steroid therapy

ACTIVE COMPARATOR

Oral beclomethasone dipropionate at dose of 10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks plus MC- EVOO for 12 weeks at a dose of 2 tablespoons per day (1 before lunch and 1 before dinner). Each spoon will contain 10 grams of oil containing 5 mg of biophenols.

Combination Product: Beclomethasone dipropionate in addition to MC-EVOO

Refined olive oil and steroid therapy

PLACEBO COMPARATOR

Oral beclomethasone dipropionate (10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks) plus placebo consisting of refined olive oil with low biophenols.

Combination Product: Beclomethasone dipropionate in addition to refined oil

Interventions

Beclomethasone dipropionate in addition to MC-EVOO COMBINATION_PRODUCT

Oral beclomethasone dipropionate at dose of 10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks plus MC- EVOO for 12 weeks at a dose of 2 tablespoons per day (1 before lunch and 1 before dinner). Each spoon will contain 10 grams of oil containing 5 mg of biophenols.

MC-EVOO in addition to steroid therapy

Beclomethasone dipropionate in addition to refined oil COMBINATION_PRODUCT

Oral beclomethasone dipropionate (10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks) plus placebo consisting of refined olive oil with low biophenols.

Refined olive oil and steroid therapy

Eligibility Criteria

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

You may qualify if:

• Patients with active UC (diagnosed for at least 3 months) aged 18 to 70 years
• Patients with mild to moderate disease (calculated by Mayo score).
• Patients can provide their informed consent to participate in the study

You may not qualify if:

• Patients with Crohn's disease
• Patients with complicated disease, who are candidates for urgent surgery
• Patients with colostomy
• Patients with contraindications to steroid therapy (diabetes mellitus, severe osteoporosis, vertebral fractures, previous intolerance to steroid therapy)
• Patients with unstable or inappropriately controlled cardiovascular, pulmonary, hepatic, renal or hematologic diseases
• Patients who are not compliant
• Patients abusing alcohol or drugs

Sponsors & Collaborators

• Casa Sollievo della Sofferenza IRCCS: lead
• Fondazione Schena: collaborator

Study Sites (1)

IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy

RECRUITING

Related Publications (8)

• Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med. 2011 Nov 3;365(18):1713-25. doi: 10.1056/NEJMra1102942. No abstract available.

  PMID: 22047562 BACKGROUND

• Ng SC, Bernstein CN, Vatn MH, Lakatos PL, Loftus EV Jr, Tysk C, O'Morain C, Moum B, Colombel JF; Epidemiology and Natural History Task Force of the International Organization of Inflammatory Bowel Disease (IOIBD). Geographical variability and environmental risk factors in inflammatory bowel disease. Gut. 2013 Apr;62(4):630-49. doi: 10.1136/gutjnl-2012-303661. Epub 2013 Jan 18.

  PMID: 23335431 BACKGROUND

• Koloski NA, Bret L, Radford-Smith G. Hygiene hypothesis in inflammatory bowel disease: a critical review of the literature. World J Gastroenterol. 2008 Jan 14;14(2):165-73. doi: 10.3748/wjg.14.165.

  PMID: 18186549 BACKGROUND

• Sanchez-Fidalgo S, Sanchez de Ibarguen L, Cardeno A, Alarcon de la Lastra C. Influence of extra virgin olive oil diet enriched with hydroxytyrosol in a chronic DSS colitis model. Eur J Nutr. 2012 Jun;51(4):497-506. doi: 10.1007/s00394-011-0235-y. Epub 2011 Aug 27.

  PMID: 21874330 BACKGROUND

• Takashima T, Sakata Y, Iwakiri R, Shiraishi R, Oda Y, Inoue N, Nakayama A, Toda S, Fujimoto K. Feeding with olive oil attenuates inflammation in dextran sulfate sodium-induced colitis in rat. J Nutr Biochem. 2014 Feb;25(2):186-92. doi: 10.1016/j.jnutbio.2013.10.005. Epub 2013 Nov 8.

  PMID: 24445043 BACKGROUND

• Reddy KVK, Naidu KA. Oleic acid, hydroxytyrosol and n-3 fatty acids collectively modulate colitis through reduction of oxidative stress and IL-8 synthesis; in vitro and in vivo studies. Int Immunopharmacol. 2016 Jun;35:29-42. doi: 10.1016/j.intimp.2016.03.019. Epub 2016 Mar 24.

  PMID: 27016717 BACKGROUND

• Hawthorne AB, Daneshmend TK, Hawkey CJ, Belluzzi A, Everitt SJ, Holmes GK, Malkinson C, Shaheen MZ, Willars JE. Treatment of ulcerative colitis with fish oil supplementation: a prospective 12 month randomised controlled trial. Gut. 1992 Jul;33(7):922-8. doi: 10.1136/gut.33.7.922.

  PMID: 1353742 BACKGROUND

• Larussa T, Oliverio M, Suraci E, Greco M, Placida R, Gervasi S, Marasco R, Imeneo M, Paolino D, Tucci L, Gulletta E, Fresta M, Procopio A, Luzza F. Oleuropein Decreases Cyclooxygenase-2 and Interleukin-17 Expression and Attenuates Inflammatory Damage in Colonic Samples from Ulcerative Colitis Patients. Nutrients. 2017 Apr 15;9(4):391. doi: 10.3390/nu9040391.

  PMID: 28420140 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Central Study Contacts

Fabrizio Bossa, MD

CONTACT

+39 0882416281; f.bossa@operapadrepio.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Patients will receive a bottle with experiental oil or placebo, consisting of commercial refined olive oil. No diffencences between the two bottles.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: Pilot study

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: January 24, 2018
• Study Start: November 20, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 31, 2019
• Last Updated: February 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)