Effect of Propolis on Patients Infected With H. Pylori

The Effect of Propolis and Nutritional Education in Patients With H. Pylori on Gastrointestinal Symptoms

This research aims to contribute to the literature by researching the effect of propolis as an add-on treatment and nutritional education on patients with H pylori and the alleviation of gastrointestinal symptoms.In order to achieve this, we offered propolis and educational nutrion programme to our 96 patients and check on their symptoms on a regular basis to note any improvement by measuring the alleviation using GSRS.

Study Overview

• Status: Not yet recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Dietary supplement: propolis solved in lactic acid solvent; Drug: Amoxicillin-Clarithromycin-Lansoprazole; Other: Lactic acid; Other: IV saline 0.9%

Detailed Description

The informed voluntary consent was taken from the patients who agreed to attend the research and the patients, Group 1 propolis with lactic acid extract on top of the treatment given by doctor Group 2 Lactic acid extract on top of the treatment by the doctor Group 3 the treatment given by the doctor and placebo treatment ,will be distributed by the method of randomized double blind trial.The patients will be provided with 500 mg (≌60 drops/day) of propolis or propolis with lactic acid extract in the morning,afternoon and evening for 14 days.The face-to-face Survey data collection method will be utilized and the researcher inform the patients about the diet and nutrition education against pylori and propolis.The presentation for the Patient Education and Propolis is given in the appendix.

The survey form consists of 4 parts; descriptive general information,eating habits,Gastrointestinal Symptoms Rating Scale (GSRS) and the frequency of The consumption of particular food. In order to rate the gastrointestinal symptoms of the patients the GSRS scale which was validated and deemed reliable in Turkish will be used The foods that increase the frequency of gastrointestinal symptoms such as spicy foods,chocolate,Chips,carbonated drinks,citrus fruits are also questioned in terms of frequency of consumption.

In order to investigate the patients adherence to the study, reminders will be taking place by giving them a call two times a week. At the end of the intervention period,GSRS scale will be reused to assess the patients.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Fatma Z Arvas, Student; Phone Number: +90 542 779 63 07; Email: arvas.zehra666@gmail.com
• Study Contact Backup: Name: Ali T Atayoglu, Asst. Prof.; Phone Number: +90 532 464 95 76; Email: atatayoglu@medipol.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The detection of H pylori infection by a specialized physician.

Exclusion Criteria:Bees and bees products allergies and the patients who use drugs that has bleomycin as an active compound will be excluded as it was found in the rats that these types of antitumor drugs can interact with propolis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Group 1 propolis with lactic acid extract on top of the treatment given by doctor	Dietary supplement: propolis solved in lactic acid solvent; propolis given as a dietary supplement which was solved in a lactic acid solvent.; Drug: Amoxicillin-Clarithromycin-Lansoprazole; H pylori eradication treatment
Other: Group 2; Grorup 2 Lactic acid extract on top of the treatment by the doctor	Drug: Amoxicillin-Clarithromycin-Lansoprazole; H pylori eradication treatment; Other: Lactic acid; given to determine if the improvement of the symptoms are due to propolis or the solvent
Placebo Comparator: Group 3; Group 3 the treatment given by the doctor and placebo treatment	Drug: Amoxicillin-Clarithromycin-Lansoprazole; H pylori eradication treatment; Other: IV saline 0.9%; Physiological serum solution is given as a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Symptom Rating Scale	The follow up of the patients are done by Gastrointestinal Symptom Rating Scale	14 days

Collaborators and Investigators

• Sponsor: Fatma Zehra Arvas
• Collaborators: Apipark Beekeeping

Publications and helpful links

Helpful Links

• Effect of propolis in gastric disorders: inhibition studies on the growth of Helicobacter pylori and production of its urease
• Propolis polyphenolic compounds affect the viability and structure of Helicobacter pylori in vitro
• CHARACTERIZATION OF Helicobacter pylori, RESEARCH OF INHIBITION EFFECTS OF HONEY AND PROPOLIS SAMPLES ON BACTERIA AND UREASE
• Reliability and Validity of the Turkish Version of the Gastrointestinal Symptom Rating Scale
• Brazilian Green Propolis on Helicobacter pylori Infection. A Pilot Clinical Study
• The Effect of Propolis as a Functional Product on Health

Study record dates

Study Major Dates

• Study Start (Anticipated): February 22, 2022
• Primary Completion (Anticipated): March 23, 2022
• Study Completion (Anticipated): April 5, 2022

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 17, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: H.Pylori,Propolis,Nutritional Education,PUD
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole; Amoxicillin; Clarithromycin; Propolis
• Other Study ID Numbers: E-77979112-424.04.01-82

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: It was decided that only the investigators could access the participants data and it will remain confidential to all other outsiders.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No