Effect of Propolis on Patients Infected With H. Pylori

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Helicobacter Pylori Infection

Intervention / Treatment
-----------------
* Dietary Supplement: propolis solved in lactic acid solvent
* Drug: Amoxicillin-Clarithromycin-Lansoprazole
* Other: IV saline 0.9%
* Other: Lactic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 96 patients divided into three groups: 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
Masking: Double


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
H.Pylori,Propolis,Nutritional Education,PUD