Helicobacter Pylori InfectionLactoBismuNCT03925818
Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication
A study testing Bismuth Subcitrate Potassium and Gastrus in people with Helicobacter Pylori Infection, run by Università degli Studi di Sassari at 1 site in Italy.
Trial summary
This study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Bismuth Subcitrate Potassium and Gastrus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteItaly
- Study dates
- 29 Aug 2017to 23 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive for H. pylori infection
Who cannot join
- Presence of malignancy
- Pregnancy or lactation
- Clinically significant diseases
- History of drug or alcohol abuse
- Allergy to pantoprazole or to any component of regimens used in the study
- Use of anti-secretory drugs, antibiotics or probiotics 4 weeks preceding the enrollment.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Clinica Medica, Dipartimento di Medicina Clinica e Sperimentale
Sassari, SS, 07100
About this study
Official title: Twice-a-day PPI, Tetracycline, Metronidazolequadruple Therapy With Pylera® or Lactobacillus Reuteri for Treatment naïve or for Retreatment of H. Pylori: Two Randomized Pilot Studies
This study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection.
Read the detailed description
Bismuth, metronidazole and tetracycline yielded high cure rates for H. pylori infection. Earlier studies suggested that the bismuth quadruple therapy may be effective when given twice-a-day rather than q.i.d. and that b.i.d. therapy was associated with fewer side effects. The addition of the probiotic Lactobacillus reuteri (Gastrus®) to Lactobacillus reuteri (Gastrus®) that has been shown to increase the cure rates by 10-14%. In another study bismuth supplementation with L. reuteri DSM 17938, in a modified low dose quadruple therapy provided good eradication rates (93.3%; 95% CI : 85-99%) in clinical practice.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Bismuth Subcitrate Potassium, Gastrus
- Keywords
- Lactobacillus reuteri; Bismuth; Helicobacter pylori;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bismuth Subcitrate PotassiumDrug
Also called Pylera, Metronidazole, Tetracycline, pantoprazole, Bismuth
Pylera capsules
GastrusDietary supplement
Also called L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475
Gastrus 1 tablet
| Study group | Role | What they receive |
|---|---|---|
| B.I.D. TMPPI + Lactobacillus-10 | Experimental | pantoprazole 20 mg, tetracycline 500 mg, and metronidazole 500 mg twice a day supplemented with 1 capsule (2 x 108 CFU of L. reuteri DSM 17938 plus 2 x 108 CFU of L. reuteri ATCC PTA 6475) a day in the afternoon, given with the midday and evening meals for 10 days Receives: Drug: Bismuth Subcitrate Potassium |
| B.I.D. Bismuth | Active comparator | pantoprazole 20 mg and the same doses of antibiotics administered as tetracycline 250 mg, and metronidazole 250 mg plus 1 cp (140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride administered) x 2 all drugs twice-a-day given with the midday and evening meals for 10 days Receives: Dietary Supplement: Gastrus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
a negative 13C-urea breath test and/or a negative stool antigen test
Measured: 30-40 days after the end of treatment
Secondary outcomes (1)
Compliance and side effects evaluation
Patient interview at the end of treatment
Measured: 30-40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start29 Aug 2017
- Primary completion29 Nov 2018
- Study completion23 Dec 2018
Why it stopped: Lactobacillus reuteri (Gastrus®) was not anymore available in the region
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
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Sassari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Pina Dore, Università degli Studi di Sassari
- Investigators
- MARIA P Dore, MD, PhD, Principal investigator, Università degli Studi di Sassari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925818
- Sponsor's protocol ID
- 2358/CE
- Acronym
- LactoBismu
- Status last verified
- Apr 2019
- First submitted
- 19 Apr 2019
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twice-a-day PPI, Tetracycline, Metronidazolequadruple Therapy With Pylera® or Lactobacillus Reuteri for Treatment naïve or for Retreatment of H. Pylori: Two Randomized Pilot Studies
- ClinicalTrials.gov ID
- NCT03925818
- Acronym / sponsor ID
- LactoBismu / 2358/CE
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Lactobacillus reuteri; Bismuth; Helicobacter pylori;
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lactobacillus reuteri (Gastrus®) was not anymore available in the region
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Università degli Studi di SassariUniversity, hospital or other
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 23 Dec 2018 (actual)
- First posted
- 24 Apr 2019 (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 study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection.
Detailed description
Bismuth, metronidazole and tetracycline yielded high cure rates for H. pylori infection. Earlier studies suggested that the bismuth quadruple therapy may be effective when given twice-a-day rather than q.i.d. and that b.i.d. therapy was associated with fewer side effects. The addition of the probiotic Lactobacillus reuteri (Gastrus®) to Lactobacillus reuteri (Gastrus®) that has been shown to increase the cure rates by 10-14%. In another study bismuth supplementation with L. reuteri DSM 17938, in a modified low dose quadruple therapy provided good eradication rates (93.3%; 95% CI : 85-99%) in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B.I.D. TMPPI + Lactobacillus-10 | Experimental | Drug: Bismuth Subcitrate Potassiumpantoprazole 20 mg, tetracycline 500 mg, and metronidazole 500 mg twice a day supplemented with 1 capsule (2 x 108 CFU of L. reuteri DSM 17938 plus 2 x 108 CFU of L. reuteri ATCC PTA 6475) a day in the afternoon, given with the midday and evening meals for 10 days |
| B.I.D. Bismuth | Active comparator | Dietary Supplement: Gastruspantoprazole 20 mg and the same doses of antibiotics administered as tetracycline 250 mg, and metronidazole 250 mg plus 1 cp (140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride administered) x 2 all drugs twice-a-day given with the midday and evening meals for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Positive for H. pylori infection
Key exclusion criteria (6 listed)
- Presence of malignancy
- Pregnancy or lactation
- Clinically significant diseases
- History of drug or alcohol abuse
- Allergy to pantoprazole or to any component of regimens used in the study
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 |
|---|---|---|
| Bismuth Subcitrate PotassiumAlso: Pylera, Metronidazole, Tetracycline, pantoprazole, BismuthPylera capsules | Drug | B.I.D. TMPPI + Lactobacillus-10 |
| GastrusAlso: L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475Gastrus 1 tablet | Dietary supplement | B.I.D. Bismuth |
Primary outcome
Helicobacter pylori eradication rate
Time frame: 30-40 days after the end of treatment
a negative 13C-urea breath test and/or a negative stool antigen test
1 secondary outcome
Compliance and side effects evaluation
Time frame: 30-40 days
Results and safety
The study was stopped early (reason given: Lactobacillus reuteri (Gastrus®) was not anymore available in the region). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
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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. This study is not recruiting at the moment.
MARIA P Dore, MD, PhD principal investigator
Università degli Studi di Sassari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bismuth Subcitrate Potassium and Gastrus in people with Helicobacter Pylori Infection, run by Università degli Studi di Sassari at 1 site in Italy.
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 1 inclusion and 6 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: stopped early, as of the sponsor's last update on 26 Apr 2019. 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 Italy. 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. 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?
The study was stopped early (reason given: Lactobacillus reuteri (Gastrus®) was not anymore available in the region). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication rate (time frame: 30-40 days after the end of treatment). 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 26 Apr 2019.