Open study to investigate if the eradication rate of H. pylori in adults is improved by L. reuteri DSM 17938, as an adjunct during 10-day eradication therapy and for 10 days thereafter. Forty-five (45) patients were included.
The rate of eradication was 93.3% (42/45). In 2/4 (50%) previously treated for H. pylori the infection was also eradicated.
Side effects were reported in 8 subjects: mild diarrhoea for a few days (n=5), and abdominal discomfort (n=3).
Proton pump inhibitor-tetracycline-metronidazole-L. reuteri therapy provided high eradication rates with few side effects, and excellent compliance.
A randomised, double blind, placebo-controlled trial set out to evaluate if 28 days of pre-administration with omeprazole (PPI) combined with 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. Fifty-five subjects were randomised, whereof 25 completed in the L. reuteri + PPI group and 28 in the placebo + PPI group. Subjects who thereafter still were positive for Hp infection, received a l0-day triple eradication therapy. Follow-up was then conducted at day 90 after initiation of intervention.
Compared to baseline, there was a decline in the proportion of subjects positive for Hp infection one week after cessation of the 28-day supplementation period and at the follow-up at day 90, but with no significant differences 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).
The administration of L. reuteri Gastrus combined with proton pump inhibitor (PPI) did not improve the rate of eradication of H. pylori.
The goals of this study were to investigate the role of a new probiotic preparation, Lactobacillus reuteri Gastrus, (L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475) in treatment of Helicobacter pylori infection.
This was a prospective, double-blind, randomized, placebo-controlled study in 100 H. pylori-positive naïve patients. Lactobacillus reuteri Gastrus (2×10^8 Colony Forming Units) (n=50) or placebo (n=50) were given to the patients throughout the stages of this 3-phase study (pre-eradication, eradication, and follow-up). All patients underwent 13C urea breath test (13C-UBT), blood assessments of gastrin-17 (G17), endoscopy, and the Gastrointestinal Symptom Rating Scale (GSRS). Eradication was confirmed by 13C-UBT 8 weeks after the completion of therapy.
During the pre-eradication period, 13C-UBT [delta] decreased by 13% in Lactobacillus reuteri Gastrus as compared with a 4% increase in placebo (-13.2+/-34% vs. 4.3+/-27%; P<0.03). During eradication, GSRS increased significantly in placebo as compared with Lactobacillus reuteri Gastrus (6.8+/-2.9 vs. 4+/-3.1; P<0.01). Significantly less patients in Lactobacillus reuteri Gastrus, as compared with placebo, reported side effects (40.9% vs. 62.8%; P<0.04). An abnormal G17 value was found in patients receiving placebo compared with Lactobacillus reuteri Gastrus (28% vs. 12%; P<0.02). Eradication rate was 75% in Lactobacillus reuteri Gastrus and 65.9% in placebo (P=NS). Lactobacillus reuteri Gastrus increased eradication rate by 9.1% (odds ratio: 1.5).
Lactobacillus reuteri Gastrus alone is able to exert an inhibitory effect on H. pylori growth, and when administered with eradication therapy, it led to a significant reduction in antibiotic-associated side effects. Moreover, Lactobacillus reuteri Gastrus was able to decrease serum G17 levels and to (not significantly) increase the H. pylori-eradication rate.
Open trial to evaluate if proton pump inhibitor pantoprazole (PPI) in combination with L. reuteri DSM 17938 may eradicate H. pylori infection in adults. Intervention was administered for 8 weeks + follow-up at 4-6 weeks thereafter. Twenty-two (22) subjects were included, given L. reuteri at the dose of 1×10^8 CFU/d plus 20 mg x 2 of pantoprazole/d.
L. reuteri plus PPI twice a day cured 13.6 % (3/22) of patients with H. pylori infection by intention-to-treat analysis and 14.2 % (3/21) by per protocol analysis. There was a significant reduction in urease activity, comparing baseline to 4–6 weeks post therapy.
Conclusion:L. reuteri may have a potential role in H. pylori eradication therapy if the cure rate can be improved by changes in dose, dosing interval, or duration of therapy.
The eradication rate of Helicobacter pylori following the standard triple therapy is declining. This study was conducted to test whether the addition of a new whether the probiotic Lactobacillus reuteri Gastrus (L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475), as an adjunct to standard triple therapy, improves the eradication rates as well as the clinical and pathological aspects in Helicobacter pylori infection.
A total of 70 treatment naive patients were randomly assigned into group A (the Lactobacillus reuteri treated group) and group B (the placebo control group). Patients were treated by the standard triple therapy for 2 weeks and either Lactobacillus reuteri or placebo for 4 weeks. They were examined by symptom questionnaire, Helicobacter pylori antigen in stool, upper endoscopy with biopsies for rapid urease test and histopathological examination before treatment and 4 weeks after completion of the supplementation period.
The eradication rate of Helicobacter pylori infection was 74.3% and 65.7% for Lactobacillus reuteri and placebo treated groups, respectively:
At 8 weeks there was a significant difference within groups in the scores of the Gastrointestinal Symptom Rating Scale (GSRS). Subjects in the L. reuteri group had greater improvement, though, than those in the placebo group (p<0.01):
A significant difference within each group was observed after treatment regarding Gastrointestinal Symptom Rating Scale (GSRS) scores; patients treated with Lactobacillus reuteri showed more improvement of gastrointestinal symptoms than the placebo treated group. The severity and activity of Helicobacter pylori associated gastritis were reduced after 4 weeks of therapy in both groups. The Lactobacillus reuteri treated group showed significant improvement compared with the placebo treated group:
The Helicobacter pylori-associated gastritis was significantly improved at the follow-up at 8 weeks, with reduction in the scores of inflammation and activity within both groups. The improvements were, however, stronger in the L. reuteri group compared to placebo: p<0.001 and p<0.05, for the inflammation and the activity score, respectively.
Triple therapy of Helicobacter pylori supplemented with Lactobacillus reuteri increased eradication rate by 8.6%, improved the GSRS score, reduced the reported side effects and improved the histological features of Helicobacter pylori infection when compared with placebo-supplemented triple therapy.
Open study investigating the effects of Lactobacillus reuteri ATCC 55730 on eradication rate and side-effects of second-line antibiotic treatment of Helicobacter pylori infection.
Ninety adult patients were randomised into two groups: Group 1 ingested 1×10^8 CFU of Lactobacillus reuteri three times daily, for 14 days from the start of the antibiotics treatment, and Group 2 received the same eradication treatment but no probiotic. The eradication treatment was taken for 7 days.
Each subject recorded gastrointestinal side-effects during 4 weeks from the start of the therapy, using a validated questionnaire. Helicobacter pylori status and side-effects were assessed 6 weeks after completion of the intervention. The incidence of moderate-severe nausea and diarrhoea was significantly reduced in the probiotic group versus control.
Conclusion:In H. pylori-positive subjects L. reuteri supplementation during and after second line eradication therapy increased the eradication rate and reduced the incidence of the most common side effects associated with antibiotic therapy in second-line treatment.
Study evaluating the effects of lactase and Lactobacillus reuteri ATCC 55730 on reduction of H2 breath excretion and gastrointestinal (GI) symptoms in lactose intolerant subjects during a standard lactose breath test (LBT).
Sixty adult subjects with lactose intolerance were randomised to three equal groups: tilactase group (tilactase 15 minutes before control H2-LBT); placebo group (placebo 15 minutes before control H2-LBT); Lactobacillus reuteri (2×10^8 CFU twice daily) for 10 days before the test.
LBT normalisation rate was significantly higher in tilactase and Lactobacillus reuteri groups compared to placebo. Tilactase was significantly more effective than Lactobacillus reuteri in achieving LBT normalisation (p <0.01). Significant reduction of mean peak H2 excretion and improvement of the mean clinical score were observed in both the tilactase and the Lactobacillus reuteri group after treatment, compared to placebo (p <0.0001). Tilactase was significantly more effective than Lactobacillus reuteri in reducing both mean peak hydrogen excretion and mean clinical score.
Conclusion: In lactose intolerant subjects tilactase strongly improves both LBT results and gastrointestinal symptoms after lactose ingestion, compared to placebo. Lactobacillus reuteri is also effective but to a lesser extent than tilactase. This probiotic may represent an interesting treatment option for lactose intolerance since its use is simple and its effect may last in the time after stopping administration.
This prospective, open-label, pilot study aimed to evaluate the therapeutic role of either Lactobacillus reuteri ATCC 55730 (1 x 10^8 CFU, twice daily) or a multi-strain, high-dose probiotic (2 x 10^10 CFU, twice daily) in addition to standard triple therapies for Helicobacter pylori eradication in 65 consecutive dyspeptic patients with Helicobacter pylori infection.
Patients were assigned to either a standard 7-day triple therapy regimen, a standard 7-day triple therapy regimen + Lactobacillus reuteri supplementation, a standard 7-day triple therapy regimen + multi-strain probiotic, or a 14-day triple therapy regimen + multi-strain probiotic.
No regimen achieved >80% eradication rate. A 14-day therapy plus the multi-strain probiotic tended to achieve a higher eradication rate (71%) although there was no statistically significant differences in terms of eradication rates between the tested regimens (7-day: 62%; 7-day + Lactobacillus reuteri: 53%; 7-day + multi-strain probiotic: 53%). Side-effects were lowest in the 7-day + Lactobacillus reuteri group (6%), but there were no statistically significant differences between the groups (7-day: 27%; 7-day + multi-strain probiotic: 20%; 14-day + probiotic: multi-strain 33%).
Conclusion: 7–14 days triple therapy with or without probiotic supplementations failed to achieve acceptable Helicobacter pylori eradication rates.
This was a prospective, double blind and placebo-controlled study in 40 dyspeptic adults infected with Helicobacter pylori. It tested whether Lactobacillus reuteri ATCC 55730 reduces the Helicobacter pylori levels in the stomach, decreases dyspeptic symptoms and affects the results of conventional treatment with antibiotics.
The subjects were randomly assigned to take Lactobacillus reuteri (1 x 10^8 CFU/day) once daily for 28 days, or placebo. Thereafter all were treated with three antibiotics and stomach acid suppressing medicine for 10 days. All subjects underwent upper endoscopy for biopsy samples from the stomach, 13C-urea breath test (UBT), and Helicobacter pylori stool antigen (HpSA) test at entry and after 4 weeks of treatment. The validated Gastrointestinal Symptom Rating Scale (GSRS) was used to assess changes in gastrointestinal symptoms. Lactobacillus reuteri reduced Helicobacter pylori levels in the patients after 4 weeks of treatment: UBT decreased from 33.8 to 27.3 ‰ (p < 0.05) and HpSA decreased in the Lactobacillus reuteri group from 18.1 to 14.4 Net/Co (p < 0.05). Both these parameters were increased in the placebo group.
Lactobacillus reuteri also decreased the GSRS values significantly as compared to pre-treatment value, 7.9 vs. 11.8 (p < 0.05), while there was no decrease in GSRS in those receiving placebo, 9.7 vs. 11.4 (p = not significant). Abdominal distension, disorders of defecation and gas were the symptoms affected in particular. There was no difference in the effect of subsequent antibiotic treatment of Helicobacter pylori between groups, and no report of adverse events.
Fig. 1 Helicobacter pylori bacterial load assessed by 13C-urea breath test (A) and HpSA (B) before and after placebo or Lactobacillus reuteri supplementation.
Conclusion: Lactobacillus reuteri effectively suppressed the Helicobacter pylori infection and reduced the overall occurrence of dyspeptic symptoms, particularly abdominal distension, abnormal defecation and gas. Lactobacillus reuteri did not affect or interfere with the antibiotic treatment of the infection.
A study investigating whether the urea breath test (UBT) could be used as a marker for burden of Helicobacter pylori infection and if administration of Lactobacillus reuteri ATCC 55730 in a chewable tablet could suppress the Helicobacter pylori level as assessed by the UBT value.
In the first study, gastric biopsies were obtained from 33 Helicobacter pylori- positive adults by upper gastrointestinal endoscopy, and the individual UBT values were established for each subject. It was shown that the individual UBT value increased significantly with the extent of the Helicobacter pylori density on the biopsies.
In the second part of the study, 40 subjects infected with Helicobacter pylori, but without symptoms, were enrolled. 35 had UBT values ≥ 15 ‰ and were randomly allocated to three groups: Group A ingested Lactobacillus reuteri for 4 weeks and placebo for another 4 weeks; group B received the two study products in the reverse order for 4 + 4 weeks; group C received only placebo for 8 weeks. Group D consisted of 5 Helicobacter pylori-negative subjects who ingested Lactobacillus reuteri only for 8 weeks.
Fig. 1 Helicobacter pylori bacterial load during oral supplementation with Lactobacillus reuteri in all Group A and B patients.
A significant decrease in UBT values was shown in groups A and B after ingesting Lactobacillus reuteri. Moreover, in group A the lower UBT value was maintained until the end of the full 8-week period. The overall rate of decrease in the UBT value due to ingestion of Lactobacillus reuteri tablets was 69.7 4.0% (p<0.05).
Conclusion: Administration of Lactobacillus reuteri significantly decreased UBT values in Helicobacter pylori-positive subjects, demonstrating that Lactobacillus reuteri suppressed Helicobacter pylori density.