Poonyam P, 2019
Thailand
Evaluate the efficacy of L. reuteri DSM 17938 + ATCC PTA 6475 (Gastrus) and quadruple therapy (bismuth, metronidazole, tetracycline, dex lansoprazole) on H. pylori eradica tion in adults (mean age 54y).
R, DB, PC 7 and 14 days
L. reuteri: 7 d: 25 (4×108 CFU) Placebo, 7 d: 25 L. reuteri 14 d: 25 (4×108 CFU) Placebo, 14 d: 25
After 14 days of treatment, the eradication rate was 96% with L. reuteri Gastrus and 88% with placebo (non-signifi cant difference). L. reuteri Gastrus significantly reduced the side-effects nausea/vomiting, abdominal discomfort and bitter taste after 14 days of treatment.
Moreno Márquez C, 2021 Spain
Evaluate the efficacy of L. reu teri DSM 17938 + ATCC PTA 6475 in reducing gastrointestinal symp toms during bismuth-containing quadruple therapy (bismuth, met ronidazole, tetracycline and ome prazole) in H. pylori-positive adults. Gastrointestinal symptoms were assed by Gastrointestinal Symptom Rating Scale (GSRS) score.
R, DB, PC Lr: 30 days Quadruple therapy: 10 days
L. reuteri: 40 (4×108 CFU) Placebo: 40
Abdominal pain was reduced in 42% of the patients in the Lr group, compared to 19% in the placebo group (p<0.001). Abdominal distension was reduced in 25% of the patients in the Lr group, compared to 17 in the placebo group (p<0.001). However, there were no differences in overall or any subscale GSRS scores between the groups at the end of treatment.
Francavilla R, 2014 Italy
To assess the effects of L. reuteri (Lr) DSM 17938 + ATCC PTA 6475 in H. pylori-infected and treatment naive, symptomatic adults, on eradications rates, and clinical and pathological parameters. Study products were administered before, during and after the 7-day treatment with omeprazole, amoxicillin and clarithromycin.
R, DB, PC 96 days w Lr and in 3 phases: d 0-28=pre eradication, d 29-35=eradica tion therapy, d 36-96=follow-up
L. reuteri: 43 (2×108 CFU) Placebo: 43
Compared with placebo, L. reuteri significantly:
• Reduced the incidence of the side effect symptoms abdo minal and epigastric pain, abdominal distension/bloating and diarrhoea
• Reduced serum levels of the inflammatory marker gast rin-17
Emara MH, 2013 Egypt
To test if the addition of L. reuteri (Lr) DSM 17938 + ATCC PTA 6475 (Gastrus) to standard triple therapy (omeprazole, amoxicillin and clarith romycin) improves the eradication rates, and clinical and pathological parameters in H. pylori-infected and treatment naive, symptomatic adults, aged 18-60y.
R, DB, PC Lr: 4 weeks Triple therapy: 2 weeks Follow-up at 8 weeks after start of inter ventions
L. reuteri: 35 (2×108 CFU) Placebo: 35
Compared to placebo, L. reuteri Gastrus significantly reduced:
• GSRS (Gastrointestinal Symptom Rating Scale)
• gastritis inflammatory cell score
• diarrhoea and taste disorders The rate of eradication of H. pylori was 74.3% (26/35) and 65.7% (23/35) in the L. reuteri Gastrus and placebo group, respectively (non-significant difference).
Francavilla R, 2008 Italy
Evaluate if pre-treatment with L. reuteri may reduce GI symptoms and bacterial load and increase eradication rate in H. pylori (Hp) infected dyspeptic adults.
R, DB, PC 28 days with L. reuteri fol lowed by 10d Hp eradication therapy
L. reuteri: 20 (1×108 CFU) Placebo: 20
L. reuteri for 4 weeks significantly:
• Reduced the load of H. pylori
• Improved GI health scores There was no additional effect on eradication rate
Lionetti E, 2006 Italy
Evaluate effects on side-effects of 10-day eradication therapy of H. pylori in children 3–18 years old.
R, DB, PC 20 days from start of eradica tion treatment
L. reuteri: 20 (1×108 CFU) Placebo: 20
Eradication of H. pylori was equally successful in both groups: 17/20 in the probiotic group vs. 16/20 in the placebo group. There were no dropouts because of treatment side effects.
Kotzev, 2015 Bulgaria
Evaluate if pre-treatment with the combination of omeprazole (PPI) and L. reuteri (Lr) (strains DSM 17938 + ATCC PTA 6475 (Gastrus) may reduce the bacterial load on its own, and increase eradication rate in H. pylori (Hp)-infected dyspeptic adults.
R, DB, PC 28 days of PPI + Lr. Thereafter l0-d. triple eradication th erapy for those still positive for Hp. Follow-up at day 90 after initiation of intervention.
L. reuteri: 25 (2×108 CFU + ome prazole) Placebo + omepra zole: 28 (2×108 CFU + ome prazole)
Compared to baseline, there was a decline in the propor tion of patients positive for Hp infection both one week after the end of the 28-day supplementation period and at the follow-up at day 90, but with no significant difference between groups. At day 90, compared to baseline, the overall presence and severity of GI symptoms had improved to the same extent in the two groups, measured by GSRS (Gastrointestinal Symptoms Rating Score).
Imase K, 2007 Japan
Evaluate the effect of L. reuteri (Lr) ATCC 55730 on infection load in non-symptomatic H. pylori-infected adults.
R, DB, PC 4 arms crossover 4 + 4 weeks
Lr g Placebo: 15 (4×108 CFU) Placebo g Lr: 15 (4×108 CFU) Lr g Lr: 5 (4×108 CFU) Placebo g placebo: 5
• L. reuteri significantly reduced H. pylori bacterial load mea sured by urea breath test
• The suppressive effect was sustained another 4 weeks in the group testing Lr first and then placebo
Ojetti V, 2012 Italy
Increase the eradication rate of H. pylori and reduce side-effects of 7 days of second line eradication treatment in adults
R, open 14 days + 6w follow-up
L. reuteri: 45 (3×108 CFU) Control: 45
L. reuteri supplementation significantly increased the eradication rate of H. pylori to 80% compared to 60% in the control group
Dore MP, 2016 Italy
Investigate if the eradication rate of H. pylori in adults is improved by L. reuteri DSM 17938, administered during the eradication therapy and for 10 days thereafter.
Open 10 days of eradication the-rapy, L. reuteri for 10+10 days
L. reuteri: 45 (1×108 CFU)
The rate of eradication was 93.3% (42/45). In 2/4 (50%) previously treated for H. pylori the infection was also eradi cated.
Side effects were reported in 8 patients: mild diarrhoea for a few days (5), and abdominal discomfort (3).