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

NCT06499649 | Completed DMC

• 1 other identifier: IBSAHP_2024
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

Probiotics; Dietary Supplementation; Eradication Therapy; Double-blinded

Outcome Measures

Primary Outcomes (1)

• EACTE (Adverse Events Correlated to Eradication Therapy) incidence

  Assessment of the incidence of "Adverse events related to eradication therapy" regardless of the degree of severity, in the group taking the dietary supplement with probiotic, compared to the group taking placebo. The adverse events related to eradication therapy are those described by the EACTE Assessment Questionnaire used

  T0 (basal) - T1 (20 ± 3 days after T0)

Secondary Outcomes (4)

• EACTE severity

  T0 (basal) - T2 (48 ± 3 days after T0)

• Eradication rate of H. pylori

  T2 (48 ± 3 days after T0)

• Severe EACTE

  T0 (basal) - T1 (20 ± 3 days after T0)

• GSRS (Gastrointestinal Symptom Rating Scale) score

  T2 (48 ± 3 days after T0)

Other Outcomes (1)

• Safety Evaluation

  T1 (20 ± 3 days after T0) and T2 (48 ± 3 days after T0)

Study Arms (2)

Control group

PLACEBO COMPARATOR

Patients under H. pylori eradication therapy and placebo as treatment

Dietary Supplement: Placebo

Treated group

EXPERIMENTAL

Patients under H. pylori eradication therapy and probiotics as treatment

Dietary Supplement: IBSA Probiotics

Interventions

IBSA Probiotics DIETARY_SUPPLEMENT

Dietary supplement base on probiotic strains.

Treated group

Placebo DIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IBSA Farmaceutici Italia Srl: lead

Study Sites (1)

Policlinico S. Orsola - Malpighi - Università di Bologna

Bologna, Italy, 40138, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 12, 2024
• Study Start: July 3, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 5, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

IT (1)