Assessment of the Adjuvant Role of Dietary Supplementation of Antibiotic-tolerant Probiotics in Standard Therapy for the Eradication of Helicobacter Pylori Infection.

NCT ID: NCT06499649

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-03
• Study Completion Date: 2025-05-05

Brief Summary

Randomized, double-blind, placebo-controlled clinical study to assess the adjuvant role of dietary supplementation of antibiotic-tolerant probiotics, derived from Lactobacillus acidophilus and Bifidobacterium animalis, in standard therapy for the eradication of Helicobacter pylori infection.

Detailed Description

Randomized, double-blind, placebo-controlled clinical study to assess the adjuvant role of dietary supplementation of antibiotic-tolerant probiotics, in standard therapy for the eradication of H. pylori infection.

The aim of this study is to evaluate the antibiotic adverse events decrease in subjects under the standard therapy for H. Pylori eradication using probiotics, compared to patients receiving the same antibiotic therapy with placebo.

This study is aimed to (naive) patients who have never received the eradication therapy.

The infection of H. Pylori will be analyzed using Urea Breath Test, esophagogastroduodenoscopy (EGDS), Histological and/or culture examination on biopsy samples.

The incidence and severity of the adverse events related to the eradication therapy will be assessed through the evaluation questionnaire EACTE (Eventi Avversi Correlati con la Terapia Eradicante) - Adverse Events correlated to Eradication Therapy.

The differences of Gastrointestinal Symptom Rating Scale (GSRS) score will be recorded to compare the two groups (patients under antibiotic therapy and probiotics/placebo treatment).

The study will involve 270 patients affected by H. pylori, with 1:1 ratio of probiotic/placebo treatment.

Each enrolled and randomized patient should take daily:

Probiotics or Placebo, depending on the treatment group assigned by randomization, (1 capsule twice a day before breakfast and dinner) for 10 days, before beginning eradication therapy. After the first 10 days of dietary supplementation with probiotics or placebo, the patient will be accompanied by dietary supplementation with eradication therapy (duration 10 days). At the end of the eradication therapy, the patient will continue feeding only probiotics or placebo for a further 4 weeks, with a dosage similar to that used before the beginning of the eradication therapy.

On the occasion of the T1 visit (after 20 days from T0 and to complete the eradication therapy), the following will be carried out:

• completion by the medical investigator of the EACTE questionnaire, on the basis of the patient's reports on any adverse events occurring during the study and related to eradication therapy, for the period between T0 and T1;
• check that the patient has taken the eradication therapy as indicated;
• registration of concurrent processing;
• recording of adverse events.

During the T2 visit (4 weeks after the end of the eradication therapy), the following will be carried out:

• urea breath test for the evaluation of HP eradication
• administration by the investigator of a questionnaire for the assessment of symptoms of functional dyspepsia, to be completed at T2 (GSRS questionnaire).
• recording of adverse events
• study conclusion Since this is a double-blind study, neither the doctor nor the patient will be aware of the nature of dietary supplementation (probiotic or placebo) assigned to the patient at T0.

Conditions

Helicobacter Pylori Infection

Study Design

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

Study Groups

Control group

Patients under H. pylori eradication therapy and placebo as treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The placebo does not contain functional components, and the appearance is indistinguishable from the comparison product.

Treated group

Patients under H. pylori eradication therapy and probiotics as treatment

Group Type: EXPERIMENTAL

IBSA Probiotics

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement base on probiotic strains.

Interventions

IBSA Probiotics

Dietary supplement base on probiotic strains.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The placebo does not contain functional components, and the appearance is indistinguishable from the comparison product.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Diagnosis of H. pylori infection by breath test and histological and/or cultural examination on biopsy (performed within 10 days prior to T0)
• Prescription of eradication therapy for HP
• Naïve patients (who have never had eradication therapy for H. pylori)
• Patients with symptoms of upper gastrointestinal tract
• Obtaining informed consent

Exclusion Criteria

• Patients with history of previous eradication attempts
• Patients with known gastric disease (e.g. atrophic gastritis, gastric cancer)
• Patients with severe organ dysfunction (cirrhosis of the liver, severe renal or respiratory failure, dialysis)
• Women who are pregnant or breastfeeding
• Patients unable to provide informed consent

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

Sponsors

IBSA Farmaceutici Italia Srl

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Policlinico S. Orsola - Malpighi - Università di Bologna

Bologna, Italy, Italy

Countries

Italy

Other Identifiers

IBSAHP_2024

Identifier Type: -

Identifier Source: org_study_id