Pylori Duo for Adjunctive Treatment and Prevention of Recurrence of Helicobacter Pylori Infection

NCT07729293 | Not Yet Recruiting

• 1 other identifier: 20260836
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, placebo-controlled, single-center clinical trial will evaluate the efficacy and safety of Pylori Duo as an adjunctive treatment in adult patients with confirmed Helicobacter pylori infection. Approximately 140 participants will be randomized to receive standard quadruple therapy (omeprazole plus Pylera®) combined with either placebo or Pylori Duo for 10 days, followed by placebo or Pylori Duo for 3 months. The primary objective is to assess the effect of Pylori Duo on gastrointestinal adverse effects associated with standard eradication therapy. Secondary objectives include assessment of H. pylori eradication, recurrence at 3 and 12 months, gastrointestinal symptoms, quality of life, and safety.

Conditions

Helicobacter Pylori Infection; Dyspepsia; Gastrointestinal Adverse Effects

Keywords

Helicobacter pylori; H. pylori infection; Pylori Duo; Adjunctive treatment; Dietary supplement; Eradication therapy; Gastrointestinal adverse effects; Placebo-controlled trial; 13C-urea breath test; Recurrence prevention

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal adverse effects associated with standard eradication therapy

  Assessment of the effect of Pylori Duo on the management of gastrointestinal adverse effects associated with standard Helicobacter pylori eradication therapy. Gastrointestinal tolerability will be evaluated during the treatment period and follow-up.

  Up to 3 months after treatment initiation

Secondary Outcomes (7)

• Helicobacter pylori eradication rate

  6 to 8 weeks after completion of the 10-day treatment phase

• Recurrence of Helicobacter pylori infection

  3 months and 12 months after completion of treatment

• Change from baseline in Gastrointestinal Symptom Rating Scale overall score

  Baseline and 3 months after treatment initiation

• Change from baseline in Short Form Nepean Dyspepsia Index total score

  Baseline and 3 months after treatment initiation

• Participants with adverse events

  Up to 3 months after the first dose

Study Arms (2)

Standard Quadruple Therapy + Placebo

PLACEBO COMPARATOR

Participants assigned to this arm will receive standard quadruple therapy consisting of omeprazole plus Pylera® in combination with placebo for 10 days during Phase I, followed by placebo for 3 months during Phase II.

Drug: Omeprazole; Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole; Other: Placebo

Standard Quadruple Therapy + Pylori Duo

EXPERIMENTAL

Participants assigned to this arm will receive standard quadruple therapy consisting of omeprazole plus Pylera® in combination with Pylori Duo for 10 days during Phase I, followed by Pylori Duo for 3 months during Phase II.

Drug: Omeprazole; Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole; Dietary Supplement: Pylori Duo

Interventions

Omeprazole DRUG

Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.

Standard Quadruple Therapy + Placebo; Standard Quadruple Therapy + Pylori Duo

Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole DRUG

Pylera® will be administered in combination with omeprazole as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.

Standard Quadruple Therapy + Placebo; Standard Quadruple Therapy + Pylori Duo

Pylori Duo DIETARY_SUPPLEMENT

Pylori Duo is a dietary supplement containing Lactobacillus rhamnosus and dried licorice extract. Participants assigned to the experimental arm will receive Pylori Duo in combination with standard quadruple therapy for 10 days, followed by Pylori Duo for 3 months during the post-treatment phase.

Standard Quadruple Therapy + Pylori Duo

Placebo OTHER

Placebo capsules identical in appearance to Pylori Duo, but without pharmacologically active ingredients, will be administered in combination with standard quadruple therapy for 10 days, followed by placebo for 3 months during the post-treatment phase.

Standard Quadruple Therapy + Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 70 years.
• Confirmed Helicobacter pylori infection prior to treatment, as determined by a positive 13C-urea breath test (13C-UBT) and gastric biopsy.
• No previous H. pylori eradication therapy.
• Ability and willingness to provide written informed consent.

You may not qualify if:

• Significant underlying conditions that, in the opinion of the treating physician, would preclude participation in the study, including hepatic insufficiency (aspartate aminotransferase or alanine aminotransferase \>3 times the upper limit of normal), renal insufficiency (creatinine ≥2.0 mg/dL or glomerular filtration rate \<50 mL/min), immunosuppression, malignant tumors, coronary heart disease or coronary artery stenosis ≥75%, thyroid disease, pulmonary disease, or any other serious medical condition.
• Pregnancy, breastfeeding, or unwillingness to use contraception during the study.
• Active gastrointestinal bleeding.
• History of upper gastrointestinal tract surgery.
• History of allergic reactions to medications included in the treatment regimen.
• Use of bismuth-containing agents, antibiotics, proton pump inhibitors, or other relevant medications within 4 weeks prior to treatment.
• Behaviors that may increase the risk of illness, including excessive alcohol consumption or substance abuse.
• Negative repeat urea breath test prior to treatment initiation.
• Unwillingness or inability to provide informed consent.

Sponsors & Collaborators

• Gala Servicios Clinicos S.L.: lead

Study Sites (1)

GALA Laboratories

Don Benito, Badajoz, 06400, Spain

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

Omeprazole; Metronidazole; Tetracycline

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Sergio Chamorro Benítez, Medicine

  Hospital Parque Vegas Altas, Don Benito (Badajoz)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Antonio Carrillo, Medicine

CONTACT

647725527; carrillo@unex.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study in which both participants and investigators will remain unaware of treatment allocation throughout the study. Placebo capsules will be identical in appearance to Pylori Duo in order to maintain blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel treatment groups. Group A will receive standard quadruple therapy (omeprazole plus Pylera®) in combination with placebo for 10 days, followed by placebo for 3 months. Group B will receive standard quadruple therapy in combination with Pylori Duo for 10 days, followed by Pylori Duo for 3 months. Both groups will be followed prospectively to assess gastrointestinal adverse effects, eradication of Helicobacter pylori, recurrence of infection, quality of life, and safety.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 27, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): October 7, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)