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NCT05259007 Clinical Trial

Effect of Propolis on Patients Infected With H. Pylori

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05259007
Other study ID # E-77979112-424.04.01-82
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date February 22, 2022
Est. completion date April 5, 2022

Study information
Verified date February 2022
Source Medipol University
Contact Fatma Z Arvas, Student
Phone +90 542 779 63 07
Email arvas.zehra666@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 96
Est. completion date April 5, 2022
Est. primary completion date March 23, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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:
• IV saline 0.9%
Physiological serum solution is given as a placebo
• Lactic acid
given to determine if the improvement of the symptoms are due to propolis or the solvent

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Fatma Zehra Arvas Apipark Beekeeping

Outcome
Type Measure Description Time frame Safety issue
Primary Gastrointestinal Symptom Rating Scale The follow up of the patients are done by Gastrointestinal Symptom Rating Scale 14 days
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