Effect of Propolis on Patients Infected With H. Pylori

NCT05259007 | Unknown Phase 4

• 1 other identifier: E-77979112-424.04.01-82
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Helicobacter Pylori Infection

Keywords

H.Pylori,Propolis,Nutritional Education,PUD

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal Symptom Rating Scale

  The follow up of the patients are done by Gastrointestinal Symptom Rating Scale

  14 days

Study Arms (3)

Group 1

EXPERIMENTAL

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

Dietary Supplement: propolis solved in lactic acid solvent; Drug: Amoxicillin-Clarithromycin-Lansoprazole

Group 2

OTHER

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

Drug: Amoxicillin-Clarithromycin-Lansoprazole; Other: Lactic acid

Group 3

PLACEBO COMPARATOR

Group 3 the treatment given by the doctor and placebo treatment

Drug: Amoxicillin-Clarithromycin-Lansoprazole; Other: IV saline 0.9%

Interventions

propolis solved in lactic acid solvent DIETARY_SUPPLEMENT

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

Group 1

Amoxicillin-Clarithromycin-Lansoprazole DRUG

H pylori eradication treatment

Group 1; Group 2; Group 3

IV saline 0.9% OTHER

Physiological serum solution is given as a placebo

Group 3

Lactic acid OTHER

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

Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Fatma Zehra Arvas: lead
• Apipark Beekeeping: collaborator

Related Links

• 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
• The Effect of Propolis as a Functional Product on Health

MeSH Terms

Interventions

Sodium Chloride; Lactic Acid

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals

Central Study Contacts

Fatma Z Arvas, Student

CONTACT

+90 542 779 63 07; arvas.zehra666@gmail.com

Ali T Atayoglu, Asst. Prof.

CONTACT

+90 532 464 95 76; atatayoglu@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind randomized controlled trial study will be utilized.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: dietitian

Model Details: 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

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: February 22, 2022
• Primary Completion: March 23, 2022
• Study Completion: April 5, 2022
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share