A Study on the Effectiveness of a Nutritional Supplement With Natural Mastiha in Inflammatory Bowel Diseases.
NCT ID: NCT02796339
Last Updated: 2021-03-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-05-31
Study Completion Date
2021-03-10
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Inflammatory Bowel Diseases
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Mastiha
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.
Group Type
ACTIVE_COMPARATOR
Mastiha
Intervention Type
DIETARY_SUPPLEMENT
Placebo
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.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DIETARY_SUPPLEMENT
Interventions
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Mastiha
Intervention Type
DIETARY_SUPPLEMENT
Placebo
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
* 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
Exclusion Criteria
* 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
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
* 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
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
Minimum Eligible Age
18 Years
Maximum Eligible Age
67 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Harokopio University
OTHER
Sponsor Role
lead
Responsible Party
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Andriana C Kaliora
"Assistant Professor in Foods & Human Nutrition"
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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ANDRIANA KALIORA, AS.PROFESSOR
Role: PRINCIPAL_INVESTIGATOR
ASS.PROFESSOR
Locations
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Harokopio University
Athens, , Greece
Site Status
Countries
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Greece
References
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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.
Reference Type
BACKGROUND
Al-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.
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BACKGROUND
Al-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.
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Georgiadis I, Karatzas T, Korou LM, Agrogiannis G, Vlachos IS, Pantopoulou A, Tzanetakou IP, Katsilambros N, Perrea DN. Evaluation of Chios mastic gum on lipid and glucose metabolism in diabetic mice. J Med Food. 2014 Mar;17(3):393-9. doi: 10.1089/jmf.2013.0069. Epub 2014 Jan 9.
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Gioxari A, Kaliora AC, Papalois A, Agrogiannis G, Triantafillidis JK, Andrikopoulos NK. Pistacia lentiscus resin regulates intestinal damage and inflammation in trinitrobenzene sulfonic acid-induced colitis. J Med Food. 2011 Nov;14(11):1403-11. doi: 10.1089/jmf.2010.0240. Epub 2011 May 25.
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Huwez FU, Al-Habbal MJ. Mastic in treatment of benign gastric ulcers. Gastroenterol Jpn. 1986 Jun;21(3):273-4. doi: 10.1007/BF02774571. No abstract available.
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Kaliora AC, Stathopoulou MG, Triantafillidis JK, Dedoussis GV, Andrikopoulos NK. Alterations in the function of circulating mononuclear cells derived from patients with Crohn's disease treated with mastic. World J Gastroenterol. 2007 Dec 7;13(45):6031-6. doi: 10.3748/wjg.v13.45.6031.
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Papalois A, Gioxari A, Kaliora AC, Lymperopoulou A, Agrogiannis G, Papada E, Andrikopoulos NK. Chios mastic fractions in experimental colitis: implication of the nuclear factor kappaB pathway in cultured HT29 cells. J Med Food. 2012 Nov;15(11):974-83. doi: 10.1089/jmf.2012.0018. Epub 2012 Aug 14.
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Triantafyllou A, Bikineyeva A, Dikalova A, Nazarewicz R, Lerakis S, Dikalov S. Anti-inflammatory activity of Chios mastic gum is associated with inhibition of TNF-alpha induced oxidative stress. Nutr J. 2011 Jun 6;10:64. doi: 10.1186/1475-2891-10-64.
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BACKGROUND
Other Identifiers
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Mastiha IBD-GR (304)
Identifier Type: -
Identifier Source: org_study_id
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