Helicobacter Pylori InfectionNCT07729293
Pylori Duo for Adjunctive Treatment and Prevention of Recurrence of Helicobacter Pylori Infection
A study testing Omeprazole, Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole and Pylori Duo in people with Helicobacter Pylori Infection and Dyspepsia, run by Gala Servicios Clinicos S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection, Dyspepsia, Gastrointestinal Adverse Effects
- What is being tested?
- Omeprazole, Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole and Pylori Duo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 31 Aug 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pylori Duo as an Adjunctive Treatment and for the Prevention of Recurrence of Helicobacter Pylori Infection
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.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, single-center interventional clinical trial designed to evaluate the efficacy and safety of Pylori Duo as an adjunctive treatment in adult patients with confirmed Helicobacter pylori infection. Approximately 140 patients aged 18 to 70 years with a positive 13C-urea breath test and gastric biopsy performed before study initiation will be enrolled.
Participants will be randomly assigned to one of two parallel treatment groups. Group A will receive standard quadruple therapy consisting of omeprazole plus Pylera® in combination with placebo for 10 days, followed by placebo for 3 months. Group B will receive the same standard quadruple therapy in combination with Pylori Duo for 10 days, followed by Pylori Duo for 3 months. Both investigators and participants will remain blinded to treatment allocation throughout the study.
The primary objective of the study is to evaluate the effect of Pylori Duo on the management of gastrointestinal adverse effects associated with standard eradication therapy. Secondary objectives include evaluation of H. pylori eradication rate, recurrence of infection at 3 and 12 months after treatment, gastrointestinal symptoms assessed using the Gastrointestinal Symptom Rating Scale (GSRS), gastrointestinal quality of life assessed using the Nepean Dyspepsia Index-Short Form (NDI-SF), and safety and tolerability. Safety assessments will include the recording of adverse events, evaluation of their potential relationship to the study product, and treatment adherence monitoring.
Participants will attend scheduled follow-up visits during treatment and post-treatment follow-up. A 13C-urea breath test will be performed 6 to 8 weeks after completion of Phase I treatment to assess eradication. Follow-up will continue for 3 months after treatment completion, and a telephone assessment will be conducted at 12 months to evaluate recurrence. Statistical analyses will be performed using both intention-to-treat and per-protocol populations.
- Being tested
- Omeprazole, Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole, Pylori Duo, Placebo
- 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
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazoleDrug
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.
Pylori DuoDietary 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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Omeprazole; Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole; Dietary Supplement: Pylori Duo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months after treatment initiation
Secondary outcomes (7)
Helicobacter pylori eradication rate
Eradication of H. pylori will be assessed by negative 13C-urea breath test performed 6 to 8 weeks after completion of Phase I treatment. Gastric biopsy may also be considered according to protocol-defined diagnostic assessment.
Measured: 6 to 8 weeks after completion of the 10-day treatment phase
Recurrence of Helicobacter pylori infection
Recurrence of H. pylori infection will be evaluated during follow-up at 3 and 12 months after treatment based on post-treatment clinical assessment and protocol-defined follow-up procedures.
Measured: 3 months and 12 months after completion of treatment
Change from baseline in Gastrointestinal Symptom Rating Scale overall score
Gastrointestinal symptoms will be assessed using the 15-item Gastrointestinal Symptom Rating Scale. Each item is scored from 1, indicating no troublesome symptoms, to 7, indicating very troublesome symptoms. The overall score is calculated as the mean of the 15 item scores and ranges from 1 to 7. Higher scores indicate greater gastrointestinal symptom severity and therefore a worse outcome. Change from baseline will be evaluated during the follow-up period.
Measured: Baseline and 3 months after treatment initiation
Change from baseline in Short Form Nepean Dyspepsia Index total score
Gastrointestinal health-related quality of life will be assessed using the 10-item Short Form Nepean Dyspepsia Index. The total score ranges from 0 to 100. Higher scores indicate better gastrointestinal health-related quality of life and therefore a better outcome. Change from baseline will be evaluated during the follow-up period.
Measured: Baseline and 3 months after treatment initiation
Participants with adverse events
Number and percentage of participants who experience at least one adverse event during the assessment period.
Measured: Up to 3 months after the first dose
Participants with study product-related adverse events
Number and percentage of participants who experience at least one adverse event considered by the investigator to be related to the study product.
Measured: Up to 3 months after the first dose
Treatment adherence
Treatment adherence will be reported as the percentage of prescribed study product doses taken. The percentage will be calculated as the number of doses taken divided by the number of doses prescribed, multiplied by 100. Higher percentages indicate greater treatment adherence.
Measured: Up to 3 months after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start31 Aug 2026 (estimated)
- Primary completion7 Oct 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- 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
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gala Servicios Clinicos S.L.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergio Chamorro Benítez, Medicine, Principal investigator, Hospital Parque Vegas Altas, Don Benito (Badajoz)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729293
- Sponsor's protocol ID
- 20260836
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during the trial will not be made publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pylori Duo as an Adjunctive Treatment and for the Prevention of Recurrence of Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT07729293
- Acronym / sponsor ID
- 20260836
- Keywords
- Helicobacter pylori, H. pylori infection, Pylori Duo, Adjunctive treatment, Dietary supplement, Eradication therapy, Gastrointestinal adverse effects, Placebo-controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Gala Servicios Clinicos S.L.University, hospital or other
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 7 Oct 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 27 Jul 2026 (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 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.
Detailed description
This is a randomized, double-blind, placebo-controlled, single-center interventional clinical trial designed to evaluate the efficacy and safety of Pylori Duo as an adjunctive treatment in adult patients with confirmed Helicobacter pylori infection. Approximately 140 patients aged 18 to 70 years with a positive 13C-urea breath test and gastric biopsy performed before study initiation will be enrolled.
Participants will be randomly assigned to one of two parallel treatment groups. Group A will receive standard quadruple therapy consisting of omeprazole plus Pylera® in combination with placebo for 10 days, followed by placebo for 3 months. Group B will receive the same standard quadruple therapy in combination with Pylori Duo for 10 days, followed by Pylori Duo for 3 months. Both investigators and participants will remain blinded to treatment allocation throughout the study.
The primary objective of the study is to evaluate the effect of Pylori Duo on the management of gastrointestinal adverse effects associated with standard eradication therapy. Secondary objectives include evaluation of H. pylori eradication rate, recurrence of infection at 3 and 12 months after treatment, gastrointestinal symptoms assessed using the Gastrointestinal Symptom Rating Scale (GSRS), gastrointestinal quality of life assessed using the Nepean Dyspepsia Index-Short Form (NDI-SF), and safety and tolerability. Safety assessments will include the recording of adverse events, evaluation of their potential relationship to the study product, and treatment adherence monitoring.
Participants will attend scheduled follow-up visits during treatment and post-treatment follow-up. A 13C-urea breath test will be performed 6 to 8 weeks after completion of Phase I treatment to assess eradication. Follow-up will continue for 3 months after treatment completion, and a telephone assessment will be conducted at 12 months to evaluate recurrence. Statistical analyses will be performed using both intention-to-treat and per-protocol populations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Quadruple Therapy + Placebo | Placebo comparator | Drug: Omeprazole, Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole, Other: PlaceboParticipants 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. |
| Standard Quadruple Therapy + Pylori Duo | Experimental | Drug: Omeprazole, Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole, Dietary Supplement: Pylori DuoParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| OmeprazoleOmeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase. | Drug | Standard Quadruple Therapy + Placebo, Standard Quadruple Therapy + Pylori Duo |
| Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazolePylera® 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. | Drug | Standard Quadruple Therapy + Placebo, Standard Quadruple Therapy + Pylori Duo |
| Pylori DuoPylori 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. | Dietary supplement | Standard Quadruple Therapy + Pylori Duo |
| PlaceboPlacebo 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. | Other | Standard Quadruple Therapy + Placebo |
Primary outcome
Gastrointestinal adverse effects associated with standard eradication therapy
Time frame: Up to 3 months after treatment initiation
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.
7 secondary outcomes
Helicobacter pylori eradication rate
Time frame: 6 to 8 weeks after completion of the 10-day treatment phase
Recurrence of Helicobacter pylori infection
Time frame: 3 months and 12 months after completion of treatment
Change from baseline in Gastrointestinal Symptom Rating Scale overall score
Time frame: Baseline and 3 months after treatment initiation
Change from baseline in Short Form Nepean Dyspepsia Index total score
Time frame: Baseline and 3 months after treatment initiation
Participants with adverse events
Time frame: Up to 3 months after the first dose
Participants with study product-related adverse events
Time frame: Up to 3 months after the first dose
Treatment adherence
Time frame: Up to 3 months after the first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data collected during the trial will not be made publicly available.
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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.
Sergio Chamorro Benítez, Medicine principal investigator
Hospital Parque Vegas Altas, Don Benito (Badajoz)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omeprazole, Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole and Pylori Duo in people with Helicobacter Pylori Infection and Dyspepsia, run by Gala Servicios Clinicos S.L. at 1 site in Spain.
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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 27 Jul 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juan Antonio Carrillo, Medicine (647725527 ext. +34, carrillo@unex.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal adverse effects associated with standard eradication therapy (time frame: Up to 3 months after treatment initiation). 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 27 Jul 2026.