Ignite Creation Date:
2024-05-05 @ 10:29 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01115296
Status:
UNKNOWN
Last Update Posted:
2012-08-17
First Post:
2010-04-28
Brief Title:
Control of Helicobacter Pylori Infection by Probiotics
Sponsor:
University of Bari
Organization:
University of Bari
Study Overview
Official Title:
Control of Helicobacter Pylori Infection by Dietary Supplementation With Lactobacillus Reuteri
Status:
UNKNOWN
Status Verified Date:
2012-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Helicobacter pylori colonises an estimated 50 of the worlds 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
L 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this was concomitant with a reduction in symptoms associated with the infection Imase et al 2007 Francavilla et al 2007 unpublished data Further dietary supplementation with L reuteri during and after the period of H pylori eradication therapy has also been shown to reduce the side effects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
L 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
1 13C-UBT
2 Gastrointestinal symptom rating score GSRS
3 Serological assessment of H pylori
4 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
1 13C-UBT
2 Gastrointestinal symptom rating score GSRS
3 Measurement of marker serum peptides related to gastric inflammation
4 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 bd plus amoxycillin 1 gr bd for 5 days followed by lansoprazole 30 mg bd plus clarithromycin 250 bd and tinidazole 500 bd 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
1 Gastrointestinal symptom rating score GSRS
2 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
1 13C-UBT
2 Gastrointestinal symptom rating score GSRS
3 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
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 CFUday 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
Baseline tests
1 13C-UBT
2 Gastrointestinal symptom rating score GSRS
3 Serological assessment of H pylori
4 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
1 13C-UBT
2 Gastrointestinal symptom rating score GSRS
3 Measurement of marker serum peptides related to gastric inflammation
4 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 bd plus amoxycillin 1 gr bd for 5 days followed by lansoprazole 30 mg bd plus clarithromycin 250 bd and tinidazole 500 bd 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
1 Gastrointestinal symptom rating score GSRS
2 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
1 13C-UBT
2 Gastrointestinal symptom rating score GSRS
3 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
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 CFUday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None