Effect of Propolis on Patients Infected With H. Pylori

Fatma Zehra Arvas

Status and phase: Unknown; Phase 4

Conditions: Helicobacter Pylori Infection

Treatments: Other: Lactic acid; Other: IV saline 0.9%; Drug: Amoxicillin-Clarithromycin-Lansoprazole; Dietary Supplement: propolis solved in lactic acid solvent

Study type: Interventional

Funder types: Other

Identifiers

NCT05259007

E-77979112-424.04.01-82

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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96 participants in 3 patient groups, including a placebo group

Group 1

Experimental group

Description:

Group 1 propolis with lactic acid extract on top of the treatment given by doctor

Treatment:

Drug: Amoxicillin-Clarithromycin-Lansoprazole

Dietary Supplement: propolis solved in lactic acid solvent

Group 2

Other group

Description:

Grorup 2 Lactic acid extract on top of the treatment by the doctor

Treatment:

Drug: Amoxicillin-Clarithromycin-Lansoprazole

Other: Lactic acid

Group 3

Placebo Comparator group

Description:

Group 3 the treatment given by the doctor and placebo treatment

Treatment:

Other: IV saline 0.9%

Drug: Amoxicillin-Clarithromycin-Lansoprazole