Ulcerative Colitis Chronic MildEVORCUNCT03408847
Monocultivar Coratina Extra Virgin Olive Oil in UC Patients
A study testing Beclomethasone dipropionate in addition to MC-EVOO and Beclomethasone dipropionate in addition to refined oil in people with Ulcerative Colitis Chronic Mild, run by Casa Sollievo della Sofferenza IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis Chronic Mild
- What is being tested?
- Beclomethasone dipropionate in addition to MC-EVOO and Beclomethasone dipropionate in addition to refined oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 20 Nov 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013
Angelo Andriulli, MD, 0039 0882 410263, a.andriulli@operapadrepio.it
Orazio Palmieri, BSc, 0039 0882416281, o.palmieri@operapadrepio.it
About this study
Official title: Supplementation of Extra Virgin Olive Oil Monocultivar Coratina in Patients With Active Ulcerative Colitis
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.
Read the detailed description
Ulcerative colitis (UC) is a chronic inflammatory bowel disease of unknown etiology, which usually occurs in young adults (II-IV decade of life).
Epidemiological data have shown a north-south gradient of both incidence and prevalence of UC in European countries, with a higher prevalence in northern European countries than in the Mediterranean area. However, recent data show a reduction in these differences in the last two decades. The reasons of this reduction are unknown, but it is possible that these differences are related to a change in dietary habits in southern European countries where a diet rich in fresh fruits and vegetables (the so-called "Mediterranean diet") is gradually being replaced by a typical diet of the industrialized countries of northern Europe, characterized by high consumption of frozen or pre-packaged foods of the food industry.
These changes in the diet regime have also replaced the type of oil contained in foods, ranging from olive oil (typical of the Mediterranean diet) to fats of animal origin or vegetable oils not coming from the olives.
Olive oil is universally recognized as the symbol of the Mediterranean diet and its beneficial properties have been extensively studied.
In particular, there are scientific evidence showing an effect of virgin olive oil on the lipid metabolism, on chronic inflammation, on blood pressure, and the regulation and detoxification of free radicals.
In particular, beneficial effects would in part be related to polyphenols, potent natural antioxidants contained in olive oil.
Monocultivar Coratina extra virgin olive oil (MC-EVOO) is an Apulian olive oil that, while possessing an extraordinary health effect superior to other cultivars, is not very used because of its distinctive characteristics of bitter and spicy. The bitter and the spicy of the extra virgin olive oil obtained from Coratina monocultivar are not defects in the oil but are the expression of a very high concentration of polyphenols (up to 800-1000 mg / kg of oil) compared to other varieties which, as well as providing extraordinary health benefits to the consumer, extend the expiration date of the oil itself, preserving it from oxidative action.
The MC-EVOO is a typical of the Apulia Region and it is characterized by:
- high content of polyphenols
- natural 100% product, with no residues of chemical solvents and other toxic and harmful contaminants.
No studies have been published so far that have demonstrated a potential toxic effects of polyphenols. Instead, EVOO-C supplementation could potentially have positive effects on lipid metabolism and body weight.
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, inflammatory, metabolic, neurodegenerative, and some neoplasms.
Also the results of in vitro study showed these properties but these results have to be carefully evaluated because in vivo the polyphenols, after being absorbed into the intestine and conjugated in the liver, arrive in the blood in methylated, sulphated and glycogenated form.
These molecules are completely different from the structural point of view of native molecules. Moreover, their presence is in the concentration of nano or micro molecules. These molecules have different biological properties from native ones and are distributed differently in different tissues and cells.
In addition, in the in-vitro studies native polyphenol molecules have been used at high concentrations, or above physiological (over 100 micromoles).
This is the first reason why a clinical trial case study was planned. Polyphenols also modulate cell membranes, enzymes, transcription factors and receptors. This is the second reason why nutrigenomics will be studied during the course of the clinical trial to evaluate the effects of polyphenols on the molecular and cellular mechanisms of the inflammatory processes that are present in the ulcerative colitis.
In vivo experiments demonstrated that the administration of a diet associated with daily intake of EVOO reduces histological lesions and symptomatology in rats with a 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.
These data show that EVOO supplementation in a diet can improve the course of the disease.
Experimental studies in humans are limited. The first study published over 25 years ago concluded that administering a supplement of fish oil to the diet produced a modest reduction in corticosteroid in the active phases of the disease, but not a benefit in maintenance therapy over olive oil. This work presents important limitations:
- the content of polyphenols in the oils used is unknown
- the remission time between the two oils was not statistically significant
- there are no data on inflammation of the colon before and after treatment Recently, an in vitro study performed on intestinal mucosa obtained from 14 active UC patients showed that samples treated with oleuropein had a reduced expression of two inflammatory factors, COX-2 and IL-17, suggesting that olive oil containing oleuropein can improve inflammatory status.
The aim of the study is to evaluate whether MC- EVOO supplementation in moderate to severe UC patients needing a steroid cycle may increase the clinical response rate to medical therapy.
- Conditions
- Ulcerative Colitis Chronic Mild
- Being tested
- Beclomethasone dipropionate in addition to MC-EVOO, Beclomethasone dipropionate in addition to refined oil
- Keywords
- Ulcerative colitis, UC, Extra virgin olive oil, Polyphenols
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclomethasone dipropionate in addition to MC-EVOOCombination 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.
Beclomethasone dipropionate in addition to refined oilCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Beclomethasone dipropionate in addition to refined oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the short-term clinical response
Evaluation of the short-term clinical response rate in the 2 treatment groups
Measured: 12 weeks
Secondary outcomes (4)
Evaluation of the clinical remission
Evaluation of the clinical remission rate in the short term in the 2 treatment groups
Measured: 12 weeks
Evaluation of the endoscopic remission
Evaluation of the endoscopic remission rate after 3 months in the 2 treatment groups
Measured: 12 weeks
Evaluation of markers of inflammation
Evaluation of the rate of patients with normalization of markers of inflammation in the short and medium term in the 2 treatment groups
Measured: 12 weeks
Evaluation of adverse events
Evaluation of the rate of adverse events in the 2 treatment groups
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start20 Nov 2017
- Primary completion1 Dec 2018 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis Chronic MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa Sollievo della Sofferenza IRCCS
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Schena
- Responsible party
- Principal investigator, Angelo Andriulli, Casa Sollievo della Sofferenza IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408847
- Sponsor's protocol ID
- EVO-RCU-2017
- Acronym
- EVORCU
- Status last verified
- Feb 2018
- First submitted
- 24 Nov 2017
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med. 2011 Nov 3;365(18):1713-25. doi: 10.1056/NEJMra1102942. No abstract available.
PubMed 22047562Ng 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.
PubMed 23335431Koloski 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.
PubMed 18186549Sanchez-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.
PubMed 21874330Takashima 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.
PubMed 24445043Reddy 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.
PubMed 27016717Hawthorne 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.
PubMed 1353742Larussa 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.
PubMed 28420140
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Extra Virgin Olive Oil Monocultivar Coratina in Patients With Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT03408847
- Acronym / sponsor ID
- EVORCU / EVO-RCU-2017
- Conditions
- Ulcerative Colitis Chronic Mild
- Keywords
- Ulcerative colitis, UC, Extra virgin olive oil, Polyphenols
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Casa Sollievo della Sofferenza IRCCSUniversity, hospital or other
- Collaborators
- Fondazione Schena
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 24 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ulcerative colitis (UC) is a chronic inflammatory bowel disease of unknown etiology, which usually occurs in young adults (II-IV decade of life).
Epidemiological data have shown a north-south gradient of both incidence and prevalence of UC in European countries, with a higher prevalence in northern European countries than in the Mediterranean area. However, recent data show a reduction in these differences in the last two decades. The reasons of this reduction are unknown, but it is possible that these differences are related to a change in dietary habits in southern European countries where a diet rich in fresh fruits and vegetables (the so-called "Mediterranean diet") is gradually being replaced by a typical diet of the industrialized countries of northern Europe, characterized by high consumption of frozen or pre-packaged foods of the food industry.
These changes in the diet regime have also replaced the type of oil contained in foods, ranging from olive oil (typical of the Mediterranean diet) to fats of animal origin or vegetable oils not coming from the olives.
Olive oil is universally recognized as the symbol of the Mediterranean diet and its beneficial properties have been extensively studied.
In particular, there are scientific evidence showing an effect of virgin olive oil on the lipid metabolism, on chronic inflammation, on blood pressure, and the regulation and detoxification of free radicals.
In particular, beneficial effects would in part be related to polyphenols, potent natural antioxidants contained in olive oil.
Monocultivar Coratina extra virgin olive oil (MC-EVOO) is an Apulian olive oil that, while possessing an extraordinary health effect superior to other cultivars, is not very used because of its distinctive characteristics of bitter and spicy. The bitter and the spicy of the extra virgin olive oil obtained from Coratina monocultivar are not defects in the oil but are the expression of a very high concentration of polyphenols (up to 800-1000 mg / kg of oil) compared to other varieties which, as well as providing extraordinary health benefits to the consumer, extend the expiration date of the oil itself, preserving it from oxidative action.
The MC-EVOO is a typical of the Apulia Region and it is characterized by:
- high content of polyphenols
- natural 100% product, with no residues of chemical solvents and other toxic and harmful contaminants.
No studies have been published so far that have demonstrated a potential toxic effects of polyphenols. Instead, EVOO-C supplementation could potentially have positive effects on lipid metabolism and body weight.
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, inflammatory, metabolic, neurodegenerative, and some neoplasms.
Also the results of in vitro study showed these properties but these results have to be carefully evaluated because in vivo the polyphenols, after being absorbed into the intestine and conjugated in the liver, arrive in the blood in methylated, sulphated and glycogenated form.
These molecules are completely different from the structural point of view of native molecules. Moreover, their presence is in the concentration of nano or micro molecules. These molecules have different biological properties from native ones and are distributed differently in different tissues and cells.
In addition, in the in-vitro studies native polyphenol molecules have been used at high concentrations, or above physiological (over 100 micromoles).
This is the first reason why a clinical trial case study was planned. Polyphenols also modulate cell membranes, enzymes, transcription factors and receptors. This is the second reason why nutrigenomics will be studied during the course of the clinical trial to evaluate the effects of polyphenols on the molecular and cellular mechanisms of the inflammatory processes that are present in the ulcerative colitis.
In vivo experiments demonstrated that the administration of a diet associated with daily intake of EVOO reduces histological lesions and symptomatology in rats with a 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.
These data show that EVOO supplementation in a diet can improve the course of the disease.
Experimental studies in humans are limited. The first study published over 25 years ago concluded that administering a supplement of fish oil to the diet produced a modest reduction in corticosteroid in the active phases of the disease, but not a benefit in maintenance therapy over olive oil. This work presents important limitations:
- the content of polyphenols in the oils used is unknown
- the remission time between the two oils was not statistically significant
- there are no data on inflammation of the colon before and after treatment Recently, an in vitro study performed on intestinal mucosa obtained from 14 active UC patients showed that samples treated with oleuropein had a reduced expression of two inflammatory factors, COX-2 and IL-17, suggesting that olive oil containing oleuropein can improve inflammatory status.
The aim of the study is to evaluate whether MC- EVOO supplementation in moderate to severe UC patients needing a steroid cycle may increase the clinical response rate to medical therapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| MC-EVOO in addition to steroid therapy | Active comparator | Combination Product: Beclomethasone dipropionate in addition to MC-EVOOOral 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. |
| Refined olive oil and steroid therapy | Placebo comparator | Combination Product: Beclomethasone dipropionate in addition to refined oilOral 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beclomethasone dipropionate in addition to MC-EVOOOral 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 | MC-EVOO in addition to steroid therapy |
| Beclomethasone dipropionate in addition to refined oilOral 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 | Refined olive oil and steroid therapy |
Primary outcome
Evaluation of the short-term clinical response
Time frame: 12 weeks
Evaluation of the short-term clinical response rate in the 2 treatment groups
4 secondary outcomes
Evaluation of the clinical remission
Time frame: 12 weeks
Evaluation of the endoscopic remission
Time frame: 12 weeks
Evaluation of markers of inflammation
Time frame: 12 weeks
Evaluation of adverse events
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Background: PubMed 22047562Danese S, Fiocchi C. Ulcerative colitis. N Engl J Med. 2011 Nov 3;365(18):1713-25. doi: 10.1056/NEJMra1102942. No abstract available.
- Background: PubMed 23335431Ng 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.
- Background: PubMed 18186549Koloski 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.
- Background: PubMed 21874330Sanchez-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.
- Background: PubMed 24445043Takashima 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.
- Background: PubMed 27016717Reddy 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.
- Background: PubMed 1353742Hawthorne 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.
- Background: PubMed 28420140Larussa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beclomethasone dipropionate in addition to MC-EVOO and Beclomethasone dipropionate in addition to refined oil in people with Ulcerative Colitis Chronic Mild, run by Casa Sollievo della Sofferenza IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabrizio Bossa, MD (+39 0882416281, f.bossa@operapadrepio.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the short-term clinical response (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03408847, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.