Effect of Probiotics on Eradication of Persistent H.Pylori Infection

NCT ID: NCT05674864

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-09-10

Brief 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. 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.

Conditions

Persistent Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 (Control Group)

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.

Group Type: PLACEBO_COMPARATOR

Bifidobacterium Infants plus Enterococcus Feacium plus Lactobacillus Acidophilus

Intervention Type: DRUG

Bifidobacterium Infants, Enterococcus Feacium, and Lactobacillus Acidophilus combination will be given as one capsule three times daily for 14 days

Group 2 (Linex ® group)

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.

Group Type: ACTIVE_COMPARATOR

Bifidobacterium Infants plus Enterococcus Feacium plus Lactobacillus Acidophilus

Intervention Type: DRUG

Bifidobacterium Infants, Enterococcus Feacium, and Lactobacillus Acidophilus combination will be given as one capsule three times daily for 14 days

Interventions

Bifidobacterium Infants plus Enterococcus Feacium plus Lactobacillus Acidophilus

Bifidobacterium Infants, Enterococcus Feacium, and Lactobacillus Acidophilus combination will be given as one capsule three times daily for 14 days

Intervention Type: DRUG

Other Intervention Names

linex

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Noura Elsayed Ahmed Elsaka

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noura Elsaka

Role: PRINCIPAL_INVESTIGATOR

Tanta University

Mohamed Abd El-Moaty, Professor

Role: STUDY_CHAIR

Zagazig University

Sahar Hegazy, Professor

Role: STUDY_DIRECTOR

Tanta University

Locations

Faculty of medicine- Zagazig University

Zagazig, Sharqia Province, Egypt

Countries

Egypt

Central Contacts

Noura Elsaka

Role: CONTACT

PG_87808@pharm.tanta.edu.eg

01069364222 ext. +20

Other Identifiers

Probiotics effect on H.Pylori

Identifier Type: -

Identifier Source: org_study_id