Helicobacter pylori infection
Conditions
Interventions
Trade Name: Antibiophilus
Product Name: Antibiophilus
Pharmaceutical Form: Powder for oral solution in sachet
INN or Proposed INN: Lactobacillus casei rhamnosus (LCR 35)
Other descriptive name: LACTOB
Sponsors
Kepler Universitätsklinikum, Medcampus III, Klinik für Interne 2
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Signed the informed consent form 2. Men or women between 18 and 70 years 3. Histologically-proven Helicobacter pylori-associated gastritis prior to screening 4. Helicobacter pylori colonization confirmed by stool antigen test 5. BMI between 18.5 and 35, inclusively 6. Negative anamnesis for current pregnancy or breast-feeding at Screening and Baseline 7. Women at child-bearing potential are advised to use an effective method of birth control Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 440 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. History of previous Helicobacter pylori eradication, unless deemed to be irrelevant by the principal investigator (i.e. in cases of a long gap between first eradication and current positive H. pylori result, making reinfection the most propable explanation). 2. Known intolerances or allergies to any of the study drugs 3. Severe endoscopic manifestation, such as hemorrhagic gastritis and gastric or duodenal ulcers 4. Barrett’s oesophagus, high-grade dysplasia, or any kind of malignancy in endoscopy 5. Use of non-steroidal anti-inflammatory drugs (NSAIDS, exept acetylsalicylic acid if daily dose is = 100mg per day), antibiotics, pre- or probiotics within 4 weeks prior to enrollment 6. History of major abdominal surgery in the past (appendectomy excluded) 7. History of regular excessive alcohol intake (>40g/d for women, >80g/d for men) or drug abuse (steroid-abuse included) within the past 12 months 8. History of lactose intolerance 9. Any substantial organ impairment including severe or unstable cardiopulmonary, renal, liver, endocrine, or neuro-psychiatric disease 10. History of cancer in the last five years 11. History of chronic infectious or immune-deficient diseases 12. Existing or planned pregnancy or breast-feeding 13. Difficulty to understand the treatment or to report disease symptoms and adverse effects 14. Participation in another clinical trial and having received another IMP within the last 30 days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary: To test the hypothesis that H pylori eradication rates of a levofloxacin-based sequencial therapy are higher when combining the standard-of-care treatment with Lactobacillus casei rhamnosus, strain 35 (LCR 35, group A) than with placebo (group B) at Week 12. ;Secondary Objective: -To assess the efficacy of a levofloxacin-based sequential therapy in combination treatment with LCR compared to placebo -To study the efficacy of LCR , monotherapy plus ESO compared to placebo - To assess the efficacy of monotherapy with LCR plus ESO compared to placebo -To evaluate whether a preceding course of LCR monotherapy plus ESO will affect consecutive eradication therapy with a levofloxacin-based sequential therapy -To assess whether baseline histologic parameters are related with treatment outcomes -To assess the occurrence of adverse events related to therapy in all treatment groups based on a modified De-Boer evaluation - To evaluate the occurrence of AEs related to therapy based on a modified De-Boer evaluation -To evaluate the patients’ compliance and the number of pills returned in the treatment box -Comparing taxonomic composition, alpha diversity and beta diversity ;Primary end point(s): Proportion of patients from group A and B achieving a negative Helicobacter stool antigen test at Week 12.;Timepoint(s) of evaluation of this end point: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Positivity or negativity for Helicobacter stool antigen at week 52 comparing group A with group B -Positivity or negativity for Helicobacter stool antigen at week 12 comparing group C with group D -Positivity or negativity for Helicobacter stool antigen at week 52 comparing group C with group D -Correlation of Helicobacter eradication efficacy, i.e. positive or negative Helicobacter stool antigen test at week 12 with histologic parameters at baseline comparing all groups A to D -Treatment-related side effects according to a modified DeBoer scale comparing groups A and B or groups C and D at Visit 4 and comparing longitudinal changes from baseline to Visit 4 within the same groups - Treatment-related side effects according to a modified DeBoer scale comparing groups A and B or groups C and D at Visit 5 and comparing longitudinal changes from baseline to Visit 5 and Visit 3 within the same groups -Treatment compliance derived from the short compliance questionnaire and the number of returned medication at Visit 4 comparing groups A and B or C and D. -Comparing taxonomic composition, alpha diversity and beta diversity before and shortly after Helicobacter-specific treatment in all groups A to D -Comparing taxonomic composition, alpha diversity and beta diversity before and 3 months after Helicobacter-specific treatment in all groups A to D -Comparing taxonomic composition, alpha diversity, and beta diversity before and 12 months;Timepoint(s) of evaluation of this end point: week 2, 12, 14, 48, 52 | — |
Countries
Austria
Contacts
Public ContactAndreas Raffeiner
Mag. Andreas Raffeiner GMBH
Outcome results
None listed