Persistent Helicobacter Pylori InfectionNCT05674864
Effect of Probiotics on Eradication of Persistent H.Pylori Infection
A study testing Bifidobacterium Infants plus Enterococcus Feacium plus Lactobacillus Acidophilus in people with Persistent Helicobacter Pylori Infection, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to investigate the possible safety and efficacy of probiotics (Bifidobacterium Infants, Enterococcus Feacium, and Lactobacillus Acidophilus) on the eradication rate of Helicobacter pylori and the incidence of adverse effects (AEs) of the concurrent rescue regimen in a patient with persistent H. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Helicobacter Pylori Infection
- What is being tested?
- Bifidobacterium Infants plus Enterococcus Feacium plus Lactobacillus Acidophilus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 10 Sep 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic patients with persistent H. pylori infection of both sexes aged ≥ 18 years old years whose infection was previously confirmed by endoscopy and pathology and experienced ≥ 2 previous treatment failures.
Who cannot join
- Patients with penicillin allergy.
- Patients who have severe renal or hepatic disease.
- Patients who have severe cardiovascular, endocrinological or pulmonary disease.
- Patients with neoplastic diseases in the 5 years previous to recruitment.
- Patients with neurological or psychiatric pathology.
- Pregnant and/or lactating females
Show all 10Show fewer
- Patients with a history of allergic reactions to any medications used in the study.
- Patients with a history of taking proton pump inhibitors, H2 antagonists, bismuth, or antibiotics (amoxicillin, metronidazole, clarithromycin) in the previous 2 weeks.
- Patients on N-acetylcysteine
- Patients on drug or alcohol abuse in the past year.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of medicine- Zagazig University
Zagazig, Sharqia Province, 44519
About this study
Official title: Effect of Probiotics on Eradication Rate in Patient With Persistent Helicobacter Pylori Infection
This study aims to investigate the possible safety and efficacy of probiotics (Bifidobacterium Infants, Enterococcus Feacium, and Lactobacillus Acidophilus) on the eradication rate of Helicobacter pylori and the incidence of adverse effects (AEs) of the concurrent rescue regimen in a patient with persistent H. Pylori infection.
Read the detailed description
Over fifty percent of people worldwide are infected with the gram-negative bacteria Helicobacter pylori. This bacterial infection results in chronic gastritis and is a known risk factor for the development of gastric cancer, the second most lethal disease globally and the fourth most prevalent cancer overall.
The incidence and prevalence rates of H. Pylori in Egypt are relatively high, according to a previous study that covered the Delta region of the country, low socioeconomic status, poor sanitation, and fecal contamination of food or water are all associated with a high H. pylori prevalence.
During the COVID-19 pandemic, antibiotic resistance has been significantly rising in several countries as a result of the multiple preventative and treatment procedures being used to manage bacterial pneumonia that co-exist with the COVID-19 virus. The incidence of bacterial antibiotic resistance varies locally and seems to be changing over time in various regions, and as a result, the rate of H. pylori eradication worldwide is declining.
In about 20% of patients, an initial attempt to eradicate H. pylori fails, leaving them with a persistent infection so, it is crucial to choose medications carefully because H. pylori resistance to previously successful antibiotic treatments is on the rise. Poor nutrition, uncooperative patients, a high bacterial load in the stomach, internalization of germs, gastric acidity, gene polymorphisms, antimicrobial washout, and, most critically, antibiotic resistance are some of the variables that contribute to the failure of H. pylori eradication, severe consequence, and persistent infection.
The initial treatment plan, the usage of different antibiotics, and the existence of drug allergies should all be taken into consideration when choosing antibiotic therapy for patients with persistent H. pylori infection. It is normally advised to avoid using antibiotics included in the initial regimen. Amoxicillin can be taken again, though, as resistance seldom arises.
According to the 2022 Maastricht VI/Florence consensus report for Management of H. pylori infection, a PPI-Amoxicillin high-dose might be an option as rescue therapy, as it overcomes the issue of clarithromycin, metronidazole, or levofloxacin resistance. Fortunately, amoxicillin resistance prevalence as a beta-lactamase antibiotic has remained low and some studies reported 2% resistance in countries.
A Meta-analysis included 4 RCTs administering PPI-Amoxicillin dual therapy had an unacceptable eradication rate of 73%, which is comparable to other recommended therapies. While another recent RCT aimed to evaluate the effectiveness, compliance, and safety of High-Dose Dual Therapy (HDDT) in the management of H. pylori infection as first-line treatment and as rescue therapy, revealed that the effectiveness of HDDT was below 70% in all scenarios (both first-line and rescue treatment) and specifically was 48.4 % per protocol in patients who have been treated with HDDT as rescue treatment for 14 days.
However, further Studies are still needed to identify the effectiveness of this regimen, especially with the high antimicrobial resistance during COVID-19.
Probiotics are frequently thought to help with H. pylori eradication and lessen adverse effects caused by standard treatment. Inhibiting H. pylori colonization and adhesion which is important in determining the outcome of H. pylori-related diseases, decreasing inflammation brought on by H. pylori, modulating the immunological responses of H. pylori, lowering the frequency of side effects, and consequently increasing compliance were a handful possible mechanisms.
Probiotics may affect host immune responses by interacting with epithelial cells and regulating the release of anti-inflammatory cytokines brought on by H. pylori, which may lessen stomach activity and inflammation. The cytokine response first manifests as the production of IL-8, which causes neutrophils and monocytes to migrate to the mucus. As a result, IL-4, IL-5, IL-6, and INF- cytokines are produced by these activated monocytes and dendritic cells.
By creating organic acids, hydrogen peroxide, carbon dioxide, and other antimicrobial chemicals, probiotics like lactic acid bacteria (LAB) and Bifidobacterium may generally suppress other infections. As an add-on, Some Lactobacillus species generate bacteriocin-related antibacterial substances that may have antibacterial properties. In comparison to other strains, certain bacteriocins have more potent antibacterial action against H. pylori. Bacteriocin-like compound with an antagonistic effect against H. pylori was generated by Enterococcus faecium TM39 which inhibited the development of H. pylori.
Previous studies have examined the efficacy and safety of some types of probiotics in helicobacter pylori eradication therapy. But there is no study yet that has examined the efficacy and safety of Lactobacillus, Enterococcus- and Bifidobacterium-containing Probiotic combination on the eradication rate in persistent H. Pylori infection.
- Conditions
- Persistent Helicobacter Pylori Infection
- Being tested
- Bifidobacterium Infants plus Enterococcus Feacium plus Lactobacillus Acidophilus
- Keywords
- probiotics, Persistent Helicobacter Pylori Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium Infants plus Enterococcus Feacium plus Lactobacillus AcidophilusDrug
Also called linex
Bifidobacterium Infants, Enterococcus Feacium, and Lactobacillus Acidophilus combination will be given as one capsule three times daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control Group) | Placebo comparator | consists of 46 patients who will receive Amoxicillin 1 gm three times daily plus Lansoprazole 30 mg three times daily plus Placebo 1 capsule three times daily for 14 days. Receives: Drug: Bifidobacterium Infants plus Enterococcus Feacium plus Lactobacillus Acidophilus |
| Group 2 (Linex ® group) | Active comparator | consists of 46 patients who will receive Amoxicillin 1 gm three times daily plus Lansoprazole 30 mg three times daily plus Linex ® capsule (which contains Bifidobacterium Infants, Enterococcus Feacium, and Lactobacillus Acidophilus) 1 capsule three times daily for 14 days. Receives: Drug: Bifidobacterium Infants plus Enterococcus Feacium plus Lactobacillus Acidophilus |
What is being measured
The primary outcome is the main question the study is designed to answer.
eradication of H. Pylori infection
the eradication of H. Pylori infection which will be measured by stool antigen test, 4-6 weeks after completion of therapy. Eradication failure is defined as a positive result 4-6 weeks after completing therapy
Measured: 4-6 weeks after completion of therapy
Secondary outcomes (4)
The improvement in Glasgow dyspepsia questionnaire
The Glasgow dyspepsia questionnaire is an eight-item self-reported dyspepsia specific questionnaire. It yields a global score that ranges from 0 to 20 and higher scores indicate more severe dyspepsia.
It will be used for assessing the response to treatment in patients with dyspepsia at baseline and after 8 weeks.
Measured: at baseline and after 8 weeks
Decrease incidence of adverse drug reactions
Side effects will be described as symptoms occurring after ingestion of medication and will be assessed at 7, 14, 21, and 28 days by telephone calls and through direct meetings.
Measured: at day 7, 14, 21, and 28 after dug administration
change in Serum Pepsinogen (PG) I/II ratio
the percentage changes in Serum Pepsinogen (PG) I/II ratio) we will be evaluated for determining the success of eradication therapy for H. pylori. A significant increase in the pepsinogen I/II ratio is an indicator of successful Helicobacter pylori eradication.
Measured: at baseline and after 8 weeks
change in Serum Interleukin 8 (IL-8)
Change in Serum Interleukin 8 (IL-8) will be measured at baseline and after 8 weeks. A significant increase in serum IL-8 level is an indicator of successful Helicobacter pylori eradication because when Tissue IL-8 levels decrease toward baseline levels following eradication of H pylori infection by antibiotic therapy, the serum IL-8 levels increase.
Measured: at baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Jan 2023 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion10 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 92 patients with persistent H. pylori infection will be recruited randomly to one of the following groups: * Group 1 (Control Group): consists of 46 patients who will receive Amoxicillin 1 gm T.I.D + Lansoprazole 30 mg T.I.D. + Placebo 1 capsule T.I.D for 14 days. * Group 2 (Linex ® group): consists of 46 patients who will receive Amoxicillin 1 gm T.I.D + Lansoprazole 30 mg T.I.D + Linex ® capsule (which contains Bifidobacterium Infants, Enterococcus Feacium and Lactobacillus Acidophilus) 1 capsule T.I.D for 14 days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noura Elsayed Ahmed Elsaka, Tanta University
- Investigators
- Noura Elsaka, Principal investigator, Tanta UniversityMohamed Abd El-Moaty, Professor, Study chair, Zagazig UniversitySahar Hegazy, Professor, Study director, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674864
- Sponsor's protocol ID
- Probiotics effect on H.Pylori
- Status last verified
- Dec 2022
- First submitted
- 22 Nov 2022
- Last updated
- 9 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Eradication Rate in Patient With Persistent Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT05674864
- Acronym / sponsor ID
- Probiotics effect on H.Pylori
- Conditions
- Persistent Helicobacter Pylori Infection
- Keywords
- probiotics, Persistent Helicobacter Pylori Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 10 Sep 2023 (estimated)
- First posted
- 9 Jan 2023 (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 study aims to investigate the possible safety and efficacy of probiotics (Bifidobacterium Infants, Enterococcus Feacium, and Lactobacillus Acidophilus) on the eradication rate of Helicobacter pylori and the incidence of adverse effects (AEs) of the concurrent rescue regimen in a patient with persistent H. Pylori infection.
Detailed description
Over fifty percent of people worldwide are infected with the gram-negative bacteria Helicobacter pylori. This bacterial infection results in chronic gastritis and is a known risk factor for the development of gastric cancer, the second most lethal disease globally and the fourth most prevalent cancer overall.
The incidence and prevalence rates of H. Pylori in Egypt are relatively high, according to a previous study that covered the Delta region of the country, low socioeconomic status, poor sanitation, and fecal contamination of food or water are all associated with a high H. pylori prevalence.
During the COVID-19 pandemic, antibiotic resistance has been significantly rising in several countries as a result of the multiple preventative and treatment procedures being used to manage bacterial pneumonia that co-exist with the COVID-19 virus. The incidence of bacterial antibiotic resistance varies locally and seems to be changing over time in various regions, and as a result, the rate of H. pylori eradication worldwide is declining.
In about 20% of patients, an initial attempt to eradicate H. pylori fails, leaving them with a persistent infection so, it is crucial to choose medications carefully because H. pylori resistance to previously successful antibiotic treatments is on the rise. Poor nutrition, uncooperative patients, a high bacterial load in the stomach, internalization of germs, gastric acidity, gene polymorphisms, antimicrobial washout, and, most critically, antibiotic resistance are some of the variables that contribute to the failure of H. pylori eradication, severe consequence, and persistent infection.
The initial treatment plan, the usage of different antibiotics, and the existence of drug allergies should all be taken into consideration when choosing antibiotic therapy for patients with persistent H. pylori infection. It is normally advised to avoid using antibiotics included in the initial regimen. Amoxicillin can be taken again, though, as resistance seldom arises.
According to the 2022 Maastricht VI/Florence consensus report for Management of H. pylori infection, a PPI-Amoxicillin high-dose might be an option as rescue therapy, as it overcomes the issue of clarithromycin, metronidazole, or levofloxacin resistance. Fortunately, amoxicillin resistance prevalence as a beta-lactamase antibiotic has remained low and some studies reported 2% resistance in countries.
A Meta-analysis included 4 RCTs administering PPI-Amoxicillin dual therapy had an unacceptable eradication rate of 73%, which is comparable to other recommended therapies. While another recent RCT aimed to evaluate the effectiveness, compliance, and safety of High-Dose Dual Therapy (HDDT) in the management of H. pylori infection as first-line treatment and as rescue therapy, revealed that the effectiveness of HDDT was below 70% in all scenarios (both first-line and rescue treatment) and specifically was 48.4 % per protocol in patients who have been treated with HDDT as rescue treatment for 14 days.
However, further Studies are still needed to identify the effectiveness of this regimen, especially with the high antimicrobial resistance during COVID-19.
Probiotics are frequently thought to help with H. pylori eradication and lessen adverse effects caused by standard treatment. Inhibiting H. pylori colonization and adhesion which is important in determining the outcome of H. pylori-related diseases, decreasing inflammation brought on by H. pylori, modulating the immunological responses of H. pylori, lowering the frequency of side effects, and consequently increasing compliance were a handful possible mechanisms.
Probiotics may affect host immune responses by interacting with epithelial cells and regulating the release of anti-inflammatory cytokines brought on by H. pylori, which may lessen stomach activity and inflammation. The cytokine response first manifests as the production of IL-8, which causes neutrophils and monocytes to migrate to the mucus. As a result, IL-4, IL-5, IL-6, and INF- cytokines are produced by these activated monocytes and dendritic cells.
By creating organic acids, hydrogen peroxide, carbon dioxide, and other antimicrobial chemicals, probiotics like lactic acid bacteria (LAB) and Bifidobacterium may generally suppress other infections. As an add-on, Some Lactobacillus species generate bacteriocin-related antibacterial substances that may have antibacterial properties. In comparison to other strains, certain bacteriocins have more potent antibacterial action against H. pylori. Bacteriocin-like compound with an antagonistic effect against H. pylori was generated by Enterococcus faecium TM39 which inhibited the development of H. pylori.
Previous studies have examined the efficacy and safety of some types of probiotics in helicobacter pylori eradication therapy. But there is no study yet that has examined the efficacy and safety of Lactobacillus, Enterococcus- and Bifidobacterium-containing Probiotic combination on the eradication rate in persistent H. Pylori infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 92 patients with persistent H. pylori infection will be recruited randomly to one of the following groups: * Group 1 (Control Group): consists of 46 patients who will receive Amoxicillin 1 gm T.I.D + Lansoprazole 30 mg T.I.D. + Placebo 1 capsule T.I.D for 14 days. * Group 2 (Linex ® group): consists of 46 patients who will receive Amoxicillin 1 gm T.I.D + Lansoprazole 30 mg T.I.D + Linex ® capsule (which contains Bifidobacterium Infants, Enterococcus Feacium and Lactobacillus Acidophilus) 1 capsule T.I.D for 14 days.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control Group) | Placebo comparator | Drug: Bifidobacterium Infants plus Enterococcus Feacium plus Lactobacillus Acidophilusconsists of 46 patients who will receive Amoxicillin 1 gm three times daily plus Lansoprazole 30 mg three times daily plus Placebo 1 capsule three times daily for 14 days. |
| Group 2 (Linex ® group) | Active comparator | Drug: Bifidobacterium Infants plus Enterococcus Feacium plus Lactobacillus Acidophilusconsists of 46 patients who will receive Amoxicillin 1 gm three times daily plus Lansoprazole 30 mg three times daily plus Linex ® capsule (which contains Bifidobacterium Infants, Enterococcus Feacium, and Lactobacillus Acidophilus) 1 capsule three times daily for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic patients with persistent H. pylori infection of both sexes aged ≥ 18 years old years whose infection was previously confirmed by endoscopy and pathology and experienced ≥ 2 previous treatment failures.
Key exclusion criteria (10 listed)
- Patients with penicillin allergy.
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 |
|---|---|---|
| Bifidobacterium Infants plus Enterococcus Feacium plus Lactobacillus AcidophilusAlso: linexBifidobacterium Infants, Enterococcus Feacium, and Lactobacillus Acidophilus combination will be given as one capsule three times daily for 14 days | Drug | Group 1 (Control Group), Group 2 (Linex ® group) |
Primary outcome
eradication of H. Pylori infection
Time frame: 4-6 weeks after completion of therapy
the eradication of H. Pylori infection which will be measured by stool antigen test, 4-6 weeks after completion of therapy. Eradication failure is defined as a positive result 4-6 weeks after completing therapy
4 secondary outcomes
The improvement in Glasgow dyspepsia questionnaire
Time frame: at baseline and after 8 weeks
Decrease incidence of adverse drug reactions
Time frame: at day 7, 14, 21, and 28 after dug administration
change in Serum Pepsinogen (PG) I/II ratio
Time frame: at baseline and after 8 weeks
change in Serum Interleukin 8 (IL-8)
Time frame: at baseline and after 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: No
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.
Noura Elsaka principal investigator
Tanta University
Mohamed Abd El-Moaty, Professor study chair
Zagazig University
Sahar Hegazy, Professor study director
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium Infants plus Enterococcus Feacium plus Lactobacillus Acidophilus in people with Persistent Helicobacter Pylori Infection, run by Tanta University at 1 site in Egypt.
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 1 inclusion and 10 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 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Noura Elsaka (01069364222 ext. +20, PG_87808@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eradication of H. Pylori infection (time frame: 4-6 weeks after completion of therapy). 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 9 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.