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Effect of Propolis on Patients Infected With H. Pylori

NCT ID: NCT05259007

Last Updated: 2022-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-22

Study Completion Date

2022-04-05

Brief Summary

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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

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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.

Conditions

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Helicobacter Pylori Infection

Keywords

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H.Pylori,Propolis,Nutritional Education,PUD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double blind randomized controlled trial study will be utilized.

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

propolis solved in lactic acid solvent

Intervention Type DIETARY_SUPPLEMENT

propolis given as a dietary supplement which was solved in a lactic acid solvent.

Amoxicillin-Clarithromycin-Lansoprazole

Intervention Type DRUG

H pylori eradication treatment

Group 2

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

Group Type OTHER

Amoxicillin-Clarithromycin-Lansoprazole

Intervention Type DRUG

H pylori eradication treatment

Lactic acid

Intervention Type OTHER

given to determine if the improvement of the symptoms are due to propolis or the solvent

Group 3

Group 3 the treatment given by the doctor and placebo treatment

Group Type PLACEBO_COMPARATOR

Amoxicillin-Clarithromycin-Lansoprazole

Intervention Type DRUG

H pylori eradication treatment

IV saline 0.9%

Intervention Type OTHER

Physiological serum solution is given as a placebo

Interventions

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propolis solved in lactic acid solvent

propolis given as a dietary supplement which was solved in a lactic acid solvent.

Intervention Type DIETARY_SUPPLEMENT

Amoxicillin-Clarithromycin-Lansoprazole

H pylori eradication treatment

Intervention Type DRUG

IV saline 0.9%

Physiological serum solution is given as a placebo

Intervention Type OTHER

Lactic acid

given to determine if the improvement of the symptoms are due to propolis or the solvent

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The detection of H pylori infection by a specialized physician.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Apipark Beekeeping

UNKNOWN

Sponsor Role collaborator

Fatma Zehra Arvas

OTHER

Sponsor Role lead

Responsible Party

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Fatma Zehra Arvas

dietitian

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Fatma Z Arvas, Student

Role: CONTACT

Phone: +90 542 779 63 07

Email: [email protected]

Ali T Atayoglu, Asst. Prof.

Role: CONTACT

Phone: +90 532 464 95 76

Email: [email protected]

Related Links

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https://www.scielo.br/j/rbfar/a/3LHfSb5j7gcxJNPTFTq6ZLK/abstract/?lang=en

Propolis polyphenolic compounds affect the viability and structure of Helicobacter pylori in vitro

http://acikerisim.erdogan.edu.tr/xmlui/handle/11436/133

CHARACTERIZATION OF Helicobacter pylori, RESEARCH OF INHIBITION EFFECTS OF HONEY AND PROPOLIS SAMPLES ON BACTERIA AND UREASE

https://journals.lww.com/gastroenterologynursing/Fulltext/2017/01000/Reliability_and_Validity_of_the_Turkish_Version_of.6.aspx?casa_token=2oaHZJdvgH8AAAAA:rsEjdqS5cHOruhlESJivfm2cklYtHUgZBVvklYF_amoNHqZ-xP8OeZexcvYZVszCCfFMxF5-bEcN51yvm3o_6Q1btg

Reliability and Validity of the Turkish Version of the Gastrointestinal Symptom Rating Scale

https://dergipark.org.tr/en/download/article-file/1205293

The Effect of Propolis as a Functional Product on Health

Other Identifiers

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E-77979112-424.04.01-82

Identifier Type: -

Identifier Source: org_study_id