Helicobacter Pylori InfectionPhase 4NCT05259007
Effect of Propolis on Patients Infected With H. Pylori
A Phase 4 study testing propolis solved in lactic acid solvent, Amoxicillin-Clarithromycin-Lansoprazole and IV saline 0.9% in people with Helicobacter Pylori Infection, run by Fatma Zehra Arvas.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- propolis solved in lactic acid solvent, Amoxicillin-Clarithromycin-Lansoprazole and IV saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 22 Feb 2022to 5 Apr 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Propolis and Nutritional Education in Patients With H. Pylori on Gastrointestinal Symptoms
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.
Read the 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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- propolis solved in lactic acid solvent, Amoxicillin-Clarithromycin-Lansoprazole, IV saline 0.9%, Lactic acid
- Keywords
- H.Pylori,Propolis,Nutritional Education,PUD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propolis solved in lactic acid solventDietary supplement
propolis given as a dietary supplement which was solved in a lactic acid solvent.
Amoxicillin-Clarithromycin-LansoprazoleDrug
H pylori eradication treatment
IV saline 0.9%Other
Physiological serum solution is given as a placebo
Lactic acidOther
given to determine if the improvement of the symptoms are due to propolis or the solvent
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 propolis with lactic acid extract on top of the treatment given by doctor Receives: 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 Receives: Drug: Amoxicillin-Clarithromycin-Lansoprazole; Other: Lactic acid |
| Group 3 | Placebo comparator | Group 3 the treatment given by the doctor and placebo treatment Receives: Drug: Amoxicillin-Clarithromycin-Lansoprazole; Other: IV saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Rating Scale
The follow up of the patients are done by Gastrointestinal Symptom Rating Scale
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start22 Feb 2022 (estimated)
- Primary completion23 Mar 2022 (estimated)
- Study completion5 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatma Zehra Arvas
- Sponsor type
- University, hospital or other
- Collaborators
- Apipark Beekeeping
- Responsible party
- Sponsor-investigator, Fatma Zehra Arvas, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259007
- Sponsor's protocol ID
- E-77979112-424.04.01-82
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It was decided that only the investigators could access the participants data and it will remain confidential to all other outsiders.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Propolis and Nutritional Education in Patients With H. Pylori on Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT05259007
- Acronym / sponsor ID
- E-77979112-424.04.01-82
- Conditions
- Helicobacter Pylori Infection
- Keywords
- H.Pylori,Propolis,Nutritional Education,PUD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Fatma Zehra ArvasUniversity, hospital or other
- Collaborators
- Apipark Beekeeping
- Study start
- 22 Feb 2022 (estimated)
- Primary completion
- 23 Mar 2022 (estimated)
- Study completion
- 5 Apr 2022 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Dietary Supplement: propolis solved in lactic acid solvent, Drug: Amoxicillin-Clarithromycin-LansoprazoleGroup 1 propolis with lactic acid extract on top of the treatment given by doctor |
| Group 2 | Other | Drug: Amoxicillin-Clarithromycin-Lansoprazole, Other: Lactic acidGrorup 2 Lactic acid extract on top of the treatment by the doctor |
| Group 3 | Placebo comparator | Drug: Amoxicillin-Clarithromycin-Lansoprazole, Other: IV saline 0.9%Group 3 the treatment given by the doctor and placebo treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propolis solved in lactic acid solventpropolis given as a dietary supplement which was solved in a lactic acid solvent. | Dietary supplement | Group 1 |
| Amoxicillin-Clarithromycin-LansoprazoleH pylori eradication treatment | Drug | Group 1, Group 2, Group 3 |
| IV saline 0.9%Physiological serum solution is given as a placebo | Other | Group 3 |
| Lactic acidgiven to determine if the improvement of the symptoms are due to propolis or the solvent | Other | Group 2 |
Primary outcome
Gastrointestinal Symptom Rating Scale
Time frame: 14 days
The follow up of the patients are done by Gastrointestinal Symptom Rating Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Propolis polyphenolic compounds affect the viability and structure of Helicobacter pylori in vitroLink provided by the sponsor.
- CHARACTERIZATION OF Helicobacter pylori, RESEARCH OF INHIBITION EFFECTS OF HONEY AND PROPOLIS SAMPLES ON BACTERIA AND UREASELink provided by the sponsor.
- Reliability and Validity of the Turkish Version of the Gastrointestinal Symptom Rating ScaleLink provided by the sponsor.
- The Effect of Propolis as a Functional Product on HealthLink provided by the sponsor.
- Individual participant dataSharing planned: No. It was decided that only the investigators could access the participants data and it will remain confidential to all other outsiders.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propolis solved in lactic acid solvent, Amoxicillin-Clarithromycin-Lansoprazole and IV saline 0.9% in people with Helicobacter Pylori Infection, run by Fatma Zehra Arvas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Z Arvas, Student (+90 542 779 63 07, arvas.zehra666@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Symptom Rating Scale (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.