A Study on the Effectiveness of a Nutritional Supplement With Natural Mastiha in Inflammatory Bowel Diseases.
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 2

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. 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.
    


Intervention name(s): Mastiha; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Inflammatory Bowel Diseases; natural Mastiha; supplement