Helicobacter Pylori InfectionNCT01115296
Control of Helicobacter Pylori Infection by Probiotics
A study testing L. reuteri DSM 17938 and ATCC PTA 6475 in people with Helicobacter Pylori Infection, run by University of Bari at 1 site in Italy.
Trial summary
Helicobacter pylori colonises an estimated 50% of the world´s population (Taylor \& Blaser, 1991; Go, 2002). Despite clear clinical guidelines on the treatment of this infection (Malfertheiner et al. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- L. reuteri DSM 17938 and ATCC PTA 6475
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Aug 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 - 65 years
- Infection with H. pylori defined as ∆ > 20 ppm in the UBT test
- Non-ulcer dyspepsia
- No earlier eradication therapy for H. pylori infection
- Written informed consent
- Stated availability throughout the entire study period
- Mental ability to understand and willingness to fulfil all the details of the protocol.
Who cannot join
- Duodenal or gastric ulcer
- MALT lymphoma
- Gastric resection (at any time)
- First level relatives of gastric cancer patients
- Absence of GI symptoms
- Use of NSAIDs, aspirin or other anti-inflammatory drugs within 1 week (for occasional use) or 3 weeks (for chronic use) of inclusion
Show all 9Show fewer
- Use of oral antibiotics and/or PPIs and/or H2-antagonists during the 2 weeks prior to ingestion of the study product
- Pregnancy
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Unit of Gastroenterology
Bari, Italy, 70100
Beatrice Principi, MD, +390805592869
About this study
Official title: Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
Helicobacter pylori colonises an estimated 50% of the world´s population (Taylor \& Blaser, 1991; Go, 2002). Despite clear clinical guidelines on the treatment of this infection (Malfertheiner et al. 2007) there is a drive to find alternative ways to control this infection in a wider perspective without the complications of induction of antibiotic resistance in the pathogen.
- reuteri has been widely studied in clinical trials and has been shown to have probiotic, health-promoting effects in both adults and children (Connolly 2004; Casas \& Dobrogosz, 2000). L. reuteri has been shown in numerous studies to be safe for human consumption and it has been shown to colonise the human gastrointestinal tract (Wolf et al., 1995, Valeur et al., 2004).
Read more
Studies using supplementation with L. reuteri in both symptomatic and non-symptomatic H. pylori-infected subjects show a clear reduction of infection load after 4 weeks of use and this was concomitant with a reduction in symptoms associated with the infection (Imase et al. 2007; Francavilla et al. 2007, unpublished data). Further, dietary supplementation with L. reuteri during and after the period of H. pylori eradication therapy has also been shown to reduce the side effects of this therapy without affecting the degree of eradication (Lionetti et al., 2007). It is also feasible, through the inhibitory action of L. reuteri on H. pylori, that pre-exposure to L. reuteri may weaken H. pylori and make it more susceptible to antibiotic attack during eradication.
However, an earlier pilot study was not been able to demonstrate a reduction in gastric inflammation caused by H. pylori. This pilot study was performed with L. reuteri ATCC 55730 that has since been found to lack anti-inflammatory activity in in vitro screens. Recent selection of natural, human L. reuteri strains has identified a specific strain with strong anti-inflammatory properties in vitro (Lin et al, 2007 and submitted 2007). A combination of this strain, together with the earlier proven L. reuteri strain, is expected to lead to both a reduction of H. pylori load as well as a reduction in the gastric inflammation related to the pathogen.
Read the detailed description
INVESTIGATIONAL PLAN AND PROCEDURES Randomised, double-blind, placebo-controlled clinical trial. One hundred (100) subjects, aged 18-65 years recruited from patients with symptoms referred for consultation about H. pylori infection naive to treatment. HP infected patients will then be randomly allocated to two groups, one to receive L. reuteri and the other to receive an identical placebo preparation.
Baseline tests:
- 13C-UBT
- Gastrointestinal symptom rating score (GSRS)
- Serological assessment of H. pylori
- Measurement of marker serum peptides related to gastric inflammation.
The subjects will be asked to take the study product each day for 28 days. On Day 29, the subjects will return to the clinic for repeated analysis of:
- 13C-UBT
- Gastrointestinal symptom rating score (GSRS)
- Measurement of marker serum peptides related to gastric inflammation.
- Endoscopy with the collection of 5 gastric biopsy samples (4 from the antrum and 1 from the corpus).
After this analysis (Day 29), eradication treatment will be initiated. Patients will receive lansoprazole (30 mg b.d.) plus amoxycillin (1 gr b.d.) for 5 days followed by lansoprazole (30 mg b.d.) plus clarithromycin (250 b.d.) and tinidazole (500 b.d.) for the next 5 days, as recommended in the Maastricht III criteria (Malfertheiner et al. (2007).
The study products will be administered throughout the eradication treatment period of 10 days. At the end of eradication therapy all subjects will return to the clinic for repeated analysis of:
- Gastrointestinal symptom rating score (GSRS)
- Measurement of marker serum peptides related to gastric inflammation. At this visit patients will be given a GSRS questionnaire to complete at home 30 days after this visit. The completed GSRS shall be given to the investigators at the final visit by the patient.
The subjects will continue to take the study product for a further 60 days after the completion of eradication. After this further 60 days (to allow discrimination between recrudescence and re-infection), the level of eradication of H. pylori and the symptom score will again be analysed
- 13C-UBT
- Gastrointestinal symptom rating score (GSRS)
- Measurement of marker serum peptides related to gastric inflammation.
Concomitant treatment During the period of the study (other than during the eradication therapy), the subjects will refrain from ingestion of any kind of probiotic or bacterial preparation, antibiotics, H2-antagonists, PPIs and NSAIDs.
Study Product and Dosage L. reuteri Progastria consists of a mixture of two human strains of L. reuteri, L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475. L. reuteri DSM 17938 is essentially the same strain as L. reuteri ATCC 55730, except that it lacks plasmids that carried antibiotic resistance traits for tetracycline and lincomycin. This strain has been extensively studied in humans of all ages. L. reuteri ATCC PTA 6475 is a new strain that was isolated from the breast milk of a nursing mother (as was L. reuteri DSM 17938).
- reuteri will be delivered at a dose of 1x108 CFU of each strain of L. reuteri giving a final dose of L. reuteri of 2x108 CFU. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day. This dose of L. reuteri has been shown to be effective in a series of conditions earlier, including inhibition of H. pylori in humans, and is considered the optimal dose.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- L. reuteri DSM 17938 and ATCC PTA 6475, Placebo
- Keywords
- Helicobacter Pylori, gastritis, Probiotics, Lactobacillus Reuteri
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. reuteri DSM 17938 and ATCC PTA 6475Dietary supplement
Also called Probiotic mixture
- reuteri dose of 1x108 CFU.
PlaceboOther
Also called Placebo identical to active
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 'L. reuteri DSM 17938 and ATCC PTA 6475 | Active comparator | L. reuteri will be delivered at a dose of 1x108 CFU of each strain of L. reuteri giving a final dose of L. reuteri of 2x108 CFU. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day. Receives: Dietary Supplement: L. reuteri DSM 17938 and ATCC PTA 6475 |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
to decrease H. pylori gastric load
Primary Outcome Measures:
Decrease H. pylori gastric load by histology after 28 days compared to placebo and by 13C-UBT compared to placebo.
Measured: 28 days
Secondary outcomes (1)
To decrease dyspeptic symptoms
To decrease dyspeptic symptoms before, during and after eradication therapy as assessed by a gastro-intestinal symptom rating scale
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruggiero Francavilla, University of Bari
- Investigators
- Principi Beatrice, MD, Principal investigator, University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01115296
- Sponsor's protocol ID
- HP-Progastria
- Status last verified
- Aug 2012
- First submitted
- 28 Apr 2010
- Last updated
- 17 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Francavilla R, Lionetti E, Castellaneta SP, Magista AM, Maurogiovanni G, Bucci N, De Canio A, Indrio F, Cavallo L, Ierardi E, Miniello VL. Inhibition of Helicobacter pylori infection in humans by Lactobacillus reuteri ATCC 55730 and effect on eradication therapy: a pilot study. Helicobacter. 2008 Apr;13(2):127-34. doi: 10.1111/j.1523-5378.2008.00593.x.
PubMed 18321302
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
- ClinicalTrials.gov ID
- NCT01115296
- Acronym / sponsor ID
- HP-Progastria
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter Pylori, gastritis, Probiotics, Lactobacillus Reuteri
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of BariUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 4 May 2010 (estimated)
- 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.
Helicobacter pylori colonises an estimated 50% of the world´s population (Taylor \& Blaser, 1991; Go, 2002). Despite clear clinical guidelines on the treatment of this infection (Malfertheiner et al. 2007) there is a drive to find alternative ways to control this infection in a wider perspective without the complications of induction of antibiotic resistance in the pathogen.
- reuteri has been widely studied in clinical trials and has been shown to have probiotic, health-promoting effects in both adults and children (Connolly 2004; Casas \& Dobrogosz, 2000). L. reuteri has been shown in numerous studies to be safe for human consumption and it has been shown to colonise the human gastrointestinal tract (Wolf et al., 1995, Valeur et al., 2004).
Studies using supplementation with L. reuteri in both symptomatic and non-symptomatic H. pylori-infected subjects show a clear reduction of infection load after 4 weeks of use and this was concomitant with a reduction in symptoms associated with the infection (Imase et al. 2007; Francavilla et al. 2007, unpublished data). Further, dietary supplementation with L. reuteri during and after the period of H. pylori eradication therapy has also been shown to reduce the side effects of this therapy without affecting the degree of eradication (Lionetti et al., 2007). It is also feasible, through the inhibitory action of L. reuteri on H. pylori, that pre-exposure to L. reuteri may weaken H. pylori and make it more susceptible to antibiotic attack during eradication.
However, an earlier pilot study was not been able to demonstrate a reduction in gastric inflammation caused by H. pylori. This pilot study was performed with L. reuteri ATCC 55730 that has since been found to lack anti-inflammatory activity in in vitro screens. Recent selection of natural, human L. reuteri strains has identified a specific strain with strong anti-inflammatory properties in vitro (Lin et al, 2007 and submitted 2007). A combination of this strain, together with the earlier proven L. reuteri strain, is expected to lead to both a reduction of H. pylori load as well as a reduction in the gastric inflammation related to the pathogen.
Detailed description
INVESTIGATIONAL PLAN AND PROCEDURES Randomised, double-blind, placebo-controlled clinical trial. One hundred (100) subjects, aged 18-65 years recruited from patients with symptoms referred for consultation about H. pylori infection naive to treatment. HP infected patients will then be randomly allocated to two groups, one to receive L. reuteri and the other to receive an identical placebo preparation.
Baseline tests:
- 13C-UBT
- Gastrointestinal symptom rating score (GSRS)
- Serological assessment of H. pylori
- Measurement of marker serum peptides related to gastric inflammation.
The subjects will be asked to take the study product each day for 28 days. On Day 29, the subjects will return to the clinic for repeated analysis of:
- 13C-UBT
- Gastrointestinal symptom rating score (GSRS)
- Measurement of marker serum peptides related to gastric inflammation.
- Endoscopy with the collection of 5 gastric biopsy samples (4 from the antrum and 1 from the corpus).
After this analysis (Day 29), eradication treatment will be initiated. Patients will receive lansoprazole (30 mg b.d.) plus amoxycillin (1 gr b.d.) for 5 days followed by lansoprazole (30 mg b.d.) plus clarithromycin (250 b.d.) and tinidazole (500 b.d.) for the next 5 days, as recommended in the Maastricht III criteria (Malfertheiner et al. (2007).
The study products will be administered throughout the eradication treatment period of 10 days. At the end of eradication therapy all subjects will return to the clinic for repeated analysis of:
- Gastrointestinal symptom rating score (GSRS)
- Measurement of marker serum peptides related to gastric inflammation. At this visit patients will be given a GSRS questionnaire to complete at home 30 days after this visit. The completed GSRS shall be given to the investigators at the final visit by the patient.
The subjects will continue to take the study product for a further 60 days after the completion of eradication. After this further 60 days (to allow discrimination between recrudescence and re-infection), the level of eradication of H. pylori and the symptom score will again be analysed
- 13C-UBT
- Gastrointestinal symptom rating score (GSRS)
- Measurement of marker serum peptides related to gastric inflammation.
Concomitant treatment During the period of the study (other than during the eradication therapy), the subjects will refrain from ingestion of any kind of probiotic or bacterial preparation, antibiotics, H2-antagonists, PPIs and NSAIDs.
Study Product and Dosage L. reuteri Progastria consists of a mixture of two human strains of L. reuteri, L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475. L. reuteri DSM 17938 is essentially the same strain as L. reuteri ATCC 55730, except that it lacks plasmids that carried antibiotic resistance traits for tetracycline and lincomycin. This strain has been extensively studied in humans of all ages. L. reuteri ATCC PTA 6475 is a new strain that was isolated from the breast milk of a nursing mother (as was L. reuteri DSM 17938).
- reuteri will be delivered at a dose of 1x108 CFU of each strain of L. reuteri giving a final dose of L. reuteri of 2x108 CFU. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day. This dose of L. reuteri has been shown to be effective in a series of conditions earlier, including inhibition of H. pylori in humans, and is considered the optimal dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 'L. reuteri DSM 17938 and ATCC PTA 6475 | Active comparator | Dietary Supplement: L. reuteri DSM 17938 and ATCC PTA 6475L. reuteri will be delivered at a dose of 1x108 CFU of each strain of L. reuteri giving a final dose of L. reuteri of 2x108 CFU. One dose is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects aged 18 - 65 years
- Infection with H. pylori defined as ∆ > 20 ppm in the UBT test
- Non-ulcer dyspepsia
- No earlier eradication therapy for H. pylori infection
- Written informed consent
Key exclusion criteria (9 listed)
- Duodenal or gastric ulcer
- MALT lymphoma
- Gastric resection (at any time)
- First level relatives of gastric cancer patients
- Absence of GI symptoms
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 |
|---|---|---|
| L. reuteri DSM 17938 and ATCC PTA 6475Also: Probiotic mixtureL. reuteri dose of 1x108 CFU. | Dietary supplement | 'L. reuteri DSM 17938 and ATCC PTA 6475 |
| PlaceboAlso: Placebo identical to activePlacebo | Other | Placebo |
Primary outcome
to decrease H. pylori gastric load
Time frame: 28 days
Primary Outcome Measures: Decrease H. pylori gastric load by histology after 28 days compared to placebo and by 13C-UBT compared to placebo.
1 secondary outcome
To decrease dyspeptic symptoms
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2012.
- Background: PubMed 18321302Francavilla R, Lionetti E, Castellaneta SP, Magista AM, Maurogiovanni G, Bucci N, De Canio A, Indrio F, Cavallo L, Ierardi E, Miniello VL. Inhibition of Helicobacter pylori infection in humans by Lactobacillus reuteri ATCC 55730 and effect on eradication therapy: a pilot study. Helicobacter. 2008 Apr;13(2):127-34. doi: 10.1111/j.1523-5378.2008.00593.x.
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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.
Principi Beatrice, MD principal investigator
University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. reuteri DSM 17938 and ATCC PTA 6475 in people with Helicobacter Pylori Infection, run by University of Bari 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 7 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: status not confirmed, as of the sponsor's last update on 17 Aug 2012. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruggiero Francavilla, MD, PhD (+390805592063 ext. 2847, rfrancavilla@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to decrease H. pylori gastric load (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01115296, which also lists 1 linked publication.
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 17 Aug 2012.