A Study on the Effectiveness of a Nutritional Supplement With Natural Mastiha in Inflammatory Bowel Diseases.

March 11, 2021 updated by: Andriana C Kaliora, Harokopio University

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 17671
        • Harokopio University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Eligibility criteria for patients in relapse

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

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

Inclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Dietary supplement: Mastiha
Placebo Comparator: 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.
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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 Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harokopio University

Investigators

  • Principal Investigator: ANDRIANA KALIORA, AS.PROFESSOR, ASS.PROFESSOR

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

March 10, 2021

Study Registration Dates

First Submitted

June 2, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mastiha IBD-GR (304)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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