Inflammatory Bowel DiseasesPhase 2NCT02796339
A Study on the Effectiveness of a Nutritional Supplement With Natural Mastiha in Inflammatory Bowel Diseases.
A Phase 2 study testing Mastiha in people with Inflammatory Bowel Diseases, run by Harokopio University at 1 site in Greece.
Trial summary
The purpose of this study is to assess the effectiveness of a supplement with natural Mastiha on Inflammatory Bowel Diseases (IBD). U.S. Food and Drug Administration has classified Mastiha as GRAS. Previous research demonstrates Mastiha's safety, as well as anti-inflammatory, antimicrobial and antioxidant properties. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Mastiha
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- May 2016to 10 Mar 2021
- Phase
- Phase 2
- 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 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-67 years
- Active disease, CD defined by Harvey \& Bradshaw Activity Index ≥4; UC defined by Partial Mayo Clinic Score (2<= Mayo Scoring Index)
- Childbearing age with a negative pregnancy test at eligibility and baseline assessment
- Stable treatment with steroids for at least 2 weeks before the start of the trial, mesalamine and mesalamine analogues for 4 weeks and immunosuppressants for 8 weeks
- Stable medication during the whole period of the 3-month intervention
- Age 18-67 years
Show all 11Show fewer
- Inactive disease (>3 months), CD defined by Harvey \& Bradshaw (<6 Index) and UC defined by Partial Mayo Clinic (0-1 Mayo Scoring Index)
- Biochemical remission
- Childbearing age with a negative pregnancy test at eligibility and baseline assessment
- Stable treatment with azathioprine or mesalamine and mesalamine analogues
- Stable medication during the whole period of the 6-month intervention
Who cannot join
- Positive stool culture for enteric pathogens or Clostridium difficile toxin
- Antibiotic treatment during and 2 months prior to screening
- Bowel surgery ≤3 months prior to screening; a planned elective surgery or hospitalisation during the study; clinically significant short bowel syndrome; presence of an intra-abdominal abscess or a fistula with clinical or radiological evidence of an associated abscess; ileostomy; colostomy
- Enteral or parenteral nutrition; Alcohol or drug abuse,Vitamin or inorganic supplements, vegan or macrobiotic diet before and during the trial
- Any malignancy in the year prior to screening; CVD; peptic ulcer
- Pregnancy, lactation
Show all 14Show fewer
- Eligibility criteria for patients in remission
- Positive stool culture for enteric pathogens or Clostridium difficile toxin
- Antibiotic treatment during and 2 months prior to screening
- Bowel surgery ≤3 months prior to screening; a planned elective surgery or hospitalisation during the study; clinically significant short bowel syndrome; presence of an intra-abdominal abscess or a fistula with clinical or radiological evidence of an associated abscess; ileostomy; colostomy
- Enteral or parenteral nutrition; Alcohol or drug abuse
- Vitamin or inorganic supplements, vegan or macrobiotic diet before and during the trial
- Any malignancy in the year prior to screening; CVD; peptic ulcer
- Pregnancy, lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase-II Clinical Trial on the Effectiveness of a Nutritional Supplement With Natural Mastiha in Inflammatory Bowel Diseases Patients.
The purpose of this study is to assess the effectiveness of a supplement with natural Mastiha on Inflammatory Bowel Diseases (IBD). U.S. Food and Drug Administration has classified Mastiha as GRAS. Previous research demonstrates Mastiha's safety, as well as anti-inflammatory, antimicrobial and antioxidant properties. In addition, the European Medicine Agency has recently recognized Mastiha as a natural medicine and classified it to the category of traditional herbal medicines in diarrhea problems, mild dyspeptic disorders, skin inflammation and healing (EMA/HMPC/46758/2015). Since IBD is a chronic disease characterized by inflammation and oxidative stress and based on previous small-scale studies, the present study aims at demonstrating the effectiveness of this supplement adjunct to the conservative treatment of IBD.
To this end, confirmed IBD patients, with distinguished Ulcerative Colitis (UC) and Crohn's Disease (CD) will be enrolled based on certain inclusion and exclusion criteria. The staff of the study will provide detailed information regarding the aims, the methods, anticipated benefits and potential hazards of the study and all patients will receive the Patient Information Leaflet (PIL). Ample time (48 hours) will be provided in order to decide whether they want to participate in the protocol. Each patient agreeing to participate will sign an Informed Consent document and the staff will explain to patients that they are under no obligation to enter the trial and that they can withdraw at any time during the trial, without having to give a reason. A copy of the signed Informed Consent will be given to the participant.
Read more
100 IBD patients will be allocated to either Mastiha or placebo group. The Mastiha group will receive natural Mastiha supplement at a dose of 2.8 g daily while placebo group will receive respectively placebo. The intervention will last 3 months for patients in relapse and 6 months for patients in remission. They will receive all the supplements they will consume during the intervention at the start of the trial. Both groups will continue their medical treatment, which must be unaltered throughout the trial. Additionally, all patients will receive standard nutritional advice by dieticians and will be encouraged to report any adverse effects they may experience during the intervention. The trial will be blinded in all implicated persons; neither the staff of the trial nor the patients will be aware of which kind intervention they receive.
Patients are assessed after randomisation according to the following tools:
- Medical history
- Dietary history
- Harvey \& Bradshaw Activity Index Assessment
- Mayo Activity Index assessment
- Anthropometric data measurement: body weight (kg), height (cm), Body Mass Index (kg/m2)
- Inflammatory Bowel Disease Questionnaire
- DNA isolation from whole blood.
- Biochemical measurements: Complete blood count, albumin, lipid profile, glucose, electrolytes, liver enzymes, amylase, fibrinogen.
- Evaluation of inflammation in serum samples. Circulating serum levels of IL-6, IL-8, IL-17A, IL-17F, IL-18, IL-21, IL-22, TL1A, TGF-β, ICAM-1, MADCAM-1 and E-selectin are measured), in all active CD and UC patients. Inflammatory markers are also estimated in stool samples: calprotectin, lactoferrin and lysozyme,
- Oxidative stress assessment in serum/plasma samples. Oxidised LDL, serum oxidisability and F2-isoprostanes are quantified.
- Detection of metabolites and complete metabolomic profile in plasma samples.
- Stool samples collection for the assessment of gut microbiota in active patients.
- Genetic and epigenetic profile
Subsequent assessments: There is a biweekly telephone contact with the patients to monitor compliance and side effects. At the end of the intervention each subject undergoes the baseline assessment.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Mastiha, Placebo
- Keywords
- Inflammatory Bowel Diseases, natural Mastiha, supplement
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MastihaDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Mastiha | Active comparator | This arm of patients will receive natural Mastiha supplements at the dosage of 2.8g daily. Patients with active disease will be administered with supplements for 3 months, whereas patients in remission will be administered with supplements for 6 months. Receives: Dietary Supplement: Mastiha |
| Placebo | Placebo comparator | This arm of patients will receive placebo . Patients with active disease will be administered with placebo for 3 months, whereas patients in remission will be administered with placebo for 6 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Bowel Disease Questionnaire (IBDQ)
Measured: Change in IBDQ will be assessed at 3 months from baseline in active IBD patients and at 6 months in inactive IBD patients. Data will be presented through study completion, an average of 1 year.
Secondary outcomes (4)
Objective symptoms questionnaire (rectal bleeding and stool frequency, visible blood in faeces and urgency).
Measured: Change in objective symptoms will be assessed at 3 months from baseline in active IBD patients and at 6 months in inactive IBD patients. Data will be presented through study completion, an average of 1 year.
C-reactive protein (CRP)
Measured: Change in CRP will be assessed at 3 months from baseline in active IBD patients and at 6 months in inactive IBD patients. Data will be presented through study completion, an average of 1 year.
Lab inflammatory biomarkers through sandwich Elisa assays.
Measured: Change in lab inflammatory biomarkers will be assessed at 3 months from baseline in active IBD patients and at 6 months in inactive IBD patients. Data will be presented through study completion, an average of 1 year.
Subjective symptoms questionnaire (physician rating of disease activity)
Measured: Change in subjective symptoms will be assessed at 3 months from baseline in active IBD patients and at 6 months in inactive IBD patients. Data will be presented through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2018
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andriana C Kaliora, Harokopio University
- Investigators
- ANDRIANA KALIORA, AS.PROFESSOR, Principal investigator, ASS.PROFESSOR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796339
- Sponsor's protocol ID
- Mastiha IBD-GR (304)
- Status last verified
- Mar 2021
- First submitted
- 2 Jun 2016
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Aksoy A, Duran N, Koksal F. In vitro and in vivo antimicrobial effects of mastic chewing gum against Streptococcus mutans and mutans streptococci. Arch Oral Biol. 2006 Jun;51(6):476-81. doi: 10.1016/j.archoralbio.2005.11.003. Epub 2005 Dec 15.
PubMed 16343417Al-Habbal MJ, Al-Habbal Z, Huwez FU. A double-blind controlled clinical trial of mastic and placebo in the treatment of duodenal ulcer. Clin Exp Pharmacol Physiol. 1984 Sep-Oct;11(5):541-4. doi: 10.1111/j.1440-1681.1984.tb00864.x.
PubMed 6395994Al-Said MS, Ageel AM, Parmar NS, Tariq M. Evaluation of mastic, a crude drug obtained from Pistacia lentiscus for gastric and duodenal anti-ulcer activity. J Ethnopharmacol. 1986 Mar;15(3):271-8. doi: 10.1016/0378-8741(86)90165-0.
PubMed 3724207Appleyard CB, Hernandez G, Rios-Bedoya CF. Basic epidemiology of inflammatory bowel disease in Puerto Rico. Inflamm Bowel Dis. 2004 Mar;10(2):106-11. doi: 10.1097/00054725-200403000-00007.
PubMed 15168809Assimopoulou AN, Papageorgiou VP. GC-MS analysis of penta- and tetra-cyclic triterpenes from resins of Pistacia species. Part I. Pistacia lentiscus var. Chia. Biomed Chromatogr. 2005 May;19(4):285-311. doi: 10.1002/bmc.454.
PubMed 15651084Assimopoulou AN, Papageorgiou VP. GC-MS analysis of penta- and tetra-cyclic triterpenes from resins of Pistacia species. Part II. Pistacia terebinthus var. Chia. Biomed Chromatogr. 2005 Oct;19(8):586-605. doi: 10.1002/bmc.484.
PubMed 15770609Bjerrum JT, Wang Y, Hao F, Coskun M, Ludwig C, Gunther U, Nielsen OH. Metabonomics of human fecal extracts characterize ulcerative colitis, Crohn's disease and healthy individuals. Metabolomics. 2015;11:122-133. doi: 10.1007/s11306-014-0677-3. Epub 2014 Jun 1.
PubMed 25598765Bountziouka V, Bathrellou E, Giotopoulou A, Katsagoni C, Bonou M, Vallianou N, Barbetseas J, Avgerinos PC, Panagiotakos DB. Development, repeatability and validity regarding energy and macronutrient intake of a semi-quantitative food frequency questionnaire: methodological considerations. Nutr Metab Cardiovasc Dis. 2012 Aug;22(8):659-67. doi: 10.1016/j.numecd.2010.10.015. Epub 2011 Jan 26.
PubMed 21269818Burisch J, Munkholm P. Inflammatory bowel disease epidemiology. Curr Opin Gastroenterol. 2013 Jul;29(4):357-62. doi: 10.1097/MOG.0b013e32836229fb.
PubMed 23695429Chang S, Malter L, Hudesman D. Disease monitoring in inflammatory bowel disease. World J Gastroenterol. 2015 Oct 28;21(40):11246-59. doi: 10.3748/wjg.v21.i40.11246.
PubMed 26523100Chapman CG, Pekow J. The emerging role of miRNAs in inflammatory bowel disease: a review. Ther Adv Gastroenterol. 2015 Jan;8(1):4-22. doi: 10.1177/1756283X14547360.
PubMed 25553076Cleynen I, Boucher G, Jostins L, Schumm LP, Zeissig S, Ahmad T, Andersen V, Andrews JM, Annese V, Brand S, Brant SR, Cho JH, Daly MJ, Dubinsky M, Duerr RH, Ferguson LR, Franke A, Gearry RB, Goyette P, Hakonarson H, Halfvarson J, Hov JR, Huang H, Kennedy NA, Kupcinskas L, Lawrance IC, Lee JC, Satsangi J, Schreiber S, Theatre E, van der Meulen-de Jong AE, Weersma RK, Wilson DC; International Inflammatory Bowel Disease Genetics Consortium; Parkes M, Vermeire S, Rioux JD, Mansfield J, Silverberg MS, Radford-Smith G, McGovern DP, Barrett JC, Lees CW. Inherited determinants of Crohn's disease and ulcerative colitis phenotypes: a genetic association study. Lancet. 2016 Jan 9;387(10014):156-67. doi: 10.1016/S0140-6736(15)00465-1. Epub 2015 Oct 18.
PubMed 26490195Cohen LB, Nanau RM, Delzor F, Neuman MG. Biologic therapies in inflammatory bowel disease. Transl Res. 2014 Jun;163(6):533-56. doi: 10.1016/j.trsl.2014.01.002. Epub 2014 Jan 7.
PubMed 24467968de Cassia da Silveira e Sa R, Andrade LN, de Sousa DP. A review on anti-inflammatory activity of monoterpenes. Molecules. 2013 Jan 18;18(1):1227-54. doi: 10.3390/molecules18011227.
PubMed 23334570Duda-Chodak A, Tarko T, Satora P, Sroka P. Interaction of dietary compounds, especially polyphenols, with the intestinal microbiota: a review. Eur J Nutr. 2015 Apr;54(3):325-41. doi: 10.1007/s00394-015-0852-y. Epub 2015 Feb 12.
PubMed 25672526
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-II Clinical Trial on the Effectiveness of a Nutritional Supplement With Natural Mastiha in Inflammatory Bowel Diseases Patients.
- ClinicalTrials.gov ID
- NCT02796339
- Acronym / sponsor ID
- Mastiha IBD-GR (304)
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Inflammatory Bowel Diseases, natural Mastiha, supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 10 Jun 2016 (estimated)
- 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.
The purpose of this study is to assess the effectiveness of a supplement with natural Mastiha on Inflammatory Bowel Diseases (IBD). U.S. Food and Drug Administration has classified Mastiha as GRAS. Previous research demonstrates Mastiha's safety, as well as anti-inflammatory, antimicrobial and antioxidant properties. In addition, the European Medicine Agency has recently recognized Mastiha as a natural medicine and classified it to the category of traditional herbal medicines in diarrhea problems, mild dyspeptic disorders, skin inflammation and healing (EMA/HMPC/46758/2015). Since IBD is a chronic disease characterized by inflammation and oxidative stress and based on previous small-scale studies, the present study aims at demonstrating the effectiveness of this supplement adjunct to the conservative treatment of IBD.
To this end, confirmed IBD patients, with distinguished Ulcerative Colitis (UC) and Crohn's Disease (CD) will be enrolled based on certain inclusion and exclusion criteria. The staff of the study will provide detailed information regarding the aims, the methods, anticipated benefits and potential hazards of the study and all patients will receive the Patient Information Leaflet (PIL). Ample time (48 hours) will be provided in order to decide whether they want to participate in the protocol. Each patient agreeing to participate will sign an Informed Consent document and the staff will explain to patients that they are under no obligation to enter the trial and that they can withdraw at any time during the trial, without having to give a reason. A copy of the signed Informed Consent will be given to the participant.
100 IBD patients will be allocated to either Mastiha or placebo group. The Mastiha group will receive natural Mastiha supplement at a dose of 2.8 g daily while placebo group will receive respectively placebo. The intervention will last 3 months for patients in relapse and 6 months for patients in remission. They will receive all the supplements they will consume during the intervention at the start of the trial. Both groups will continue their medical treatment, which must be unaltered throughout the trial. Additionally, all patients will receive standard nutritional advice by dieticians and will be encouraged to report any adverse effects they may experience during the intervention. The trial will be blinded in all implicated persons; neither the staff of the trial nor the patients will be aware of which kind intervention they receive.
Patients are assessed after randomisation according to the following tools:
- Medical history
- Dietary history
- Harvey \& Bradshaw Activity Index Assessment
- Mayo Activity Index assessment
- Anthropometric data measurement: body weight (kg), height (cm), Body Mass Index (kg/m2)
- Inflammatory Bowel Disease Questionnaire
- DNA isolation from whole blood.
- Biochemical measurements: Complete blood count, albumin, lipid profile, glucose, electrolytes, liver enzymes, amylase, fibrinogen.
- Evaluation of inflammation in serum samples. Circulating serum levels of IL-6, IL-8, IL-17A, IL-17F, IL-18, IL-21, IL-22, TL1A, TGF-β, ICAM-1, MADCAM-1 and E-selectin are measured), in all active CD and UC patients. Inflammatory markers are also estimated in stool samples: calprotectin, lactoferrin and lysozyme,
- Oxidative stress assessment in serum/plasma samples. Oxidised LDL, serum oxidisability and F2-isoprostanes are quantified.
- Detection of metabolites and complete metabolomic profile in plasma samples.
- Stool samples collection for the assessment of gut microbiota in active patients.
- Genetic and epigenetic profile
Subsequent assessments: There is a biweekly telephone contact with the patients to monitor compliance and side effects. At the end of the intervention each subject undergoes the baseline assessment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mastiha | Active comparator | Dietary Supplement: MastihaThis arm of patients will receive natural Mastiha supplements at the dosage of 2.8g daily. Patients with active disease will be administered with supplements for 3 months, whereas patients in remission will be administered with supplements for 6 months. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThis arm of patients will receive placebo . Patients with active disease will be administered with placebo for 3 months, whereas patients in remission will be administered with placebo for 6 months. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18-67 years
- Active disease, CD defined by Harvey \& Bradshaw Activity Index ≥4; UC defined by Partial Mayo Clinic Score (2<= Mayo Scoring Index)
- Childbearing age with a negative pregnancy test at eligibility and baseline assessment
- Stable treatment with steroids for at least 2 weeks before the start of the trial, mesalamine and mesalamine analogues for 4 weeks and immunosuppressants for 8 weeks
- Stable medication during the whole period of the 3-month intervention
Key exclusion criteria (14 listed)
- Positive stool culture for enteric pathogens or Clostridium difficile toxin
- Antibiotic treatment during and 2 months prior to screening
- Bowel surgery ≤3 months prior to screening; a planned elective surgery or hospitalisation during the study; clinically significant short bowel syndrome; presence of an intra-abdominal abscess or a fistula with clinical or radiological evidence of an associated abscess; ileostomy; colostomy
- Enteral or parenteral nutrition; Alcohol or drug abuse,Vitamin or inorganic supplements, vegan or macrobiotic diet before and during the trial
- Any malignancy in the year prior to screening; CVD; peptic ulcer
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 |
|---|---|---|
| Mastiha | Dietary supplement | Mastiha |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: Change in IBDQ will be assessed at 3 months from baseline in active IBD patients and at 6 months in inactive IBD patients. Data will be presented through study completion, an average of 1 year.
4 secondary outcomes
Objective symptoms questionnaire (rectal bleeding and stool frequency, visible blood in faeces and urgency).
Time frame: Change in objective symptoms will be assessed at 3 months from baseline in active IBD patients and at 6 months in inactive IBD patients. Data will be presented through study completion, an average of 1 year.
C-reactive protein (CRP)
Time frame: Change in CRP will be assessed at 3 months from baseline in active IBD patients and at 6 months in inactive IBD patients. Data will be presented through study completion, an average of 1 year.
Lab inflammatory biomarkers through sandwich Elisa assays.
Time frame: Change in lab inflammatory biomarkers will be assessed at 3 months from baseline in active IBD patients and at 6 months in inactive IBD patients. Data will be presented through study completion, an average of 1 year.
Subjective symptoms questionnaire (physician rating of disease activity)
Time frame: Change in subjective symptoms will be assessed at 3 months from baseline in active IBD patients and at 6 months in inactive IBD patients. Data will be presented through study completion, an average of 1 year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Background: PubMed 16343417Aksoy A, Duran N, Koksal F. In vitro and in vivo antimicrobial effects of mastic chewing gum against Streptococcus mutans and mutans streptococci. Arch Oral Biol. 2006 Jun;51(6):476-81. doi: 10.1016/j.archoralbio.2005.11.003. Epub 2005 Dec 15.
- Background: PubMed 6395994Al-Habbal MJ, Al-Habbal Z, Huwez FU. A double-blind controlled clinical trial of mastic and placebo in the treatment of duodenal ulcer. Clin Exp Pharmacol Physiol. 1984 Sep-Oct;11(5):541-4. doi: 10.1111/j.1440-1681.1984.tb00864.x.
- Background: PubMed 3724207Al-Said MS, Ageel AM, Parmar NS, Tariq M. Evaluation of mastic, a crude drug obtained from Pistacia lentiscus for gastric and duodenal anti-ulcer activity. J Ethnopharmacol. 1986 Mar;15(3):271-8. doi: 10.1016/0378-8741(86)90165-0.
- Background: PubMed 15168809Appleyard CB, Hernandez G, Rios-Bedoya CF. Basic epidemiology of inflammatory bowel disease in Puerto Rico. Inflamm Bowel Dis. 2004 Mar;10(2):106-11. doi: 10.1097/00054725-200403000-00007.
- Background: PubMed 15651084Assimopoulou AN, Papageorgiou VP. GC-MS analysis of penta- and tetra-cyclic triterpenes from resins of Pistacia species. Part I. Pistacia lentiscus var. Chia. Biomed Chromatogr. 2005 May;19(4):285-311. doi: 10.1002/bmc.454.
- Background: PubMed 15770609Assimopoulou AN, Papageorgiou VP. GC-MS analysis of penta- and tetra-cyclic triterpenes from resins of Pistacia species. Part II. Pistacia terebinthus var. Chia. Biomed Chromatogr. 2005 Oct;19(8):586-605. doi: 10.1002/bmc.484.
- Background: PubMed 25598765Bjerrum JT, Wang Y, Hao F, Coskun M, Ludwig C, Gunther U, Nielsen OH. Metabonomics of human fecal extracts characterize ulcerative colitis, Crohn's disease and healthy individuals. Metabolomics. 2015;11:122-133. doi: 10.1007/s11306-014-0677-3. Epub 2014 Jun 1.
- Background: PubMed 21269818Bountziouka V, Bathrellou E, Giotopoulou A, Katsagoni C, Bonou M, Vallianou N, Barbetseas J, Avgerinos PC, Panagiotakos DB. Development, repeatability and validity regarding energy and macronutrient intake of a semi-quantitative food frequency questionnaire: methodological considerations. Nutr Metab Cardiovasc Dis. 2012 Aug;22(8):659-67. doi: 10.1016/j.numecd.2010.10.015. Epub 2011 Jan 26.
- Background: PubMed 23695429Burisch J, Munkholm P. Inflammatory bowel disease epidemiology. Curr Opin Gastroenterol. 2013 Jul;29(4):357-62. doi: 10.1097/MOG.0b013e32836229fb.
- Background: PubMed 26523100Chang S, Malter L, Hudesman D. Disease monitoring in inflammatory bowel disease. World J Gastroenterol. 2015 Oct 28;21(40):11246-59. doi: 10.3748/wjg.v21.i40.11246.
- Background: PubMed 25553076Chapman CG, Pekow J. The emerging role of miRNAs in inflammatory bowel disease: a review. Ther Adv Gastroenterol. 2015 Jan;8(1):4-22. doi: 10.1177/1756283X14547360.
- Background: PubMed 26490195Cleynen I, Boucher G, Jostins L, Schumm LP, Zeissig S, Ahmad T, Andersen V, Andrews JM, Annese V, Brand S, Brant SR, Cho JH, Daly MJ, Dubinsky M, Duerr RH, Ferguson LR, Franke A, Gearry RB, Goyette P, Hakonarson H, Halfvarson J, Hov JR, Huang H, Kennedy NA, Kupcinskas L, Lawrance IC, Lee JC, Satsangi J, Schreiber S, Theatre E, van der Meulen-de Jong AE, Weersma RK, Wilson DC; International Inflammatory Bowel Disease Genetics Consortium; Parkes M, Vermeire S, Rioux JD, Mansfield J, Silverberg MS, Radford-Smith G, McGovern DP, Barrett JC, Lees CW. Inherited determinants of Crohn's disease and ulcerative colitis phenotypes: a genetic association study. Lancet. 2016 Jan 9;387(10014):156-67. doi: 10.1016/S0140-6736(15)00465-1. Epub 2015 Oct 18.
- 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.
ANDRIANA KALIORA, AS.PROFESSOR principal investigator
ASS.PROFESSOR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mastiha in people with Inflammatory Bowel Diseases, run by Harokopio University at 1 site in Greece.
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 11 inclusion and 14 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: finished, as of the sponsor's last update on 12 Mar 2021. 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 Greece. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Bowel Disease Questionnaire (IBDQ) (time frame: Change in IBDQ will be assessed at 3 months from baseline in active IBD patients and at 6 months in inactive IBD patients. Data will be presented through study completion, an average of 1 year.). 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 NCT02796339, which also lists 32 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 12 Mar 2021.