Mastiha or Mastiha Water in Functional Dyspepsia

The Effect of Mastiha Products on Functional Dyspepsia. A Randomised Crossover Study.

The main aim of this study is to establish whether Mastiha products ameliorate functional dyspepsia symptoms.

Study Overview

• Status: Recruiting
• Conditions: Functional Dyspepsia
• Intervention / Treatment: Dietary supplement: Mastiha water; Dietary supplement: Mastiha capsules

Detailed Description

Functional dyspepsia has an approximate prevalence of 20% and is one of the main causes of upper abdominal discomfort. Its pathogenesis remain unclear and therapeutic options remain limited with patients seeking alternative therapies in herbal remedies. Mastiha has been proven to significantly improve symptoms in patients with functional dyspepsia compared to placebo. In the present study, the investigators aim to determine whether Mastiha capsules or Mastiha water have a better effect on the improvement of functional dyspepsia symptoms. Therefore, the investigators designed a randomized, three-way cross-over clinical trial. Fifty patients with functional dyspepsia, will be randomized over three treatment sequences of 30 days each, separated by 14-day washout periods. The three treatments will be: Mastiha capsules, Mastiha water or Mastiha free treatment. The primary outcome, which will be assessed by intention to treat, will be the Leuven Postprandial Distress Scale, a validated instrument for the assessment of symptoms in functional dyspepsia, supported by the European Medicines Agency.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andriana Kaliora, Ass. Prof.; Phone Number: 00302109549226; Email: akaliora@hua.gr

Study Locations

• Greece
  • Athens, Greece, 17671
    • Recruiting
    • Andriana Kaliora
    • Contact: Andriana C Kaliora, Ass. Prof; Phone Number: +30 2109549226; Email: akaliora@hua.gr
    • Principal Investigator: Andriana C Kaliora, Ass. Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

functional dyspepsia diagnosis according to

• Rome criteria
• negative urea breath test for Helicobacter pylori
• upper gastrointestinal tract endoscopy with biopsy

Exclusion Criteria:

• organic diseases, such as peptic ulcer, gastrointestinal neoplasms, gastroesophageal reflux, irritable bowel syndrome
• pregnancy or lactation
• history of abdominal surgery or actinotherapy
• mental illness
• Severe impairment of heart, liver, or kidney function or respiratory function
• Alcohol overuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mastiha water; Patients will receive 10ml of Mastiha water before every meal for one month	Dietary supplement: Mastiha water; 10ml of mastiha water before every meal for one month
Experimental: Mastiha capsules; Patients will receive 2 Mastiha capsules (2x350mg) before every meal for one month	Dietary supplement: Mastiha capsules; 2x350mg mastiha capsules before every meal for one month
No Intervention: Control-Mastiha free; Patients will follow a Mastiha free one month period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Leuven Postprandial Distress Scale (LPDS)	The change in Leuven Postprandial Distress Scale will be evaluated at follow-up. LPDS minimum score is 0 and maximum 32. Higher scores mean a worse outcome.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	Change in quality of life at follow-up as assessed via the EQ-5D-5L questionnaire. EQ-5D-5L has a scale from 0 to 100, with higher scores meaning better outcomes.	1 month
Sense of adequate relief	The percentage of patients with adequate relief of symptoms will be evaluated at follow-up.	1 month
Use of medicines	The percentage of patients that decreased drug dose of medicines for functional dyspepsia will be evaluated at follow-up.	1 month
Change in anxiety	Change in anxiety at follow-up as assessed via the GAD-7 ANXIETY questionnaire. GAD-7 ANXIETY has a scale from 0 to 21, with higher scores meaning worse outcomes.	1 month

Collaborators and Investigators

• Sponsor: Harokopio University
• Investigators: Study Director: Andriana C. Kaliora, Ass. Prof., Harokopio University

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): October 30, 2025

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: MASTIHA-WATER-FD

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