scholarly journals Investigating the Effect of Quadruple Therapy with Saccharomyces Boulardii or Lactobacillus Reuteri Strain (DSMZ 17648) Supplements on Eradication of Helicobacter Pylori and Treatments҆ Side Effects: A Double-Blind Placebo-Controlled Randomized Clinical Trial

Author(s):  
Nooshin Naghibzadeh ◽  
Fatemeh Salmani ◽  
Samira Nomiri ◽  
Tahmine Tavakoli

Abstract Background: The primary goal of this placebo-controlled study was to determine the effect of quadruple treatment with Saccharomyces boulardii or Lactobacillus reuteri on the eradication of Helicobacter pylori and side effects of the treatment.Results: This study was a double-blind, randomized, placebo-controlled trial. And, eradication of helicobacter pylori was reported comparing conventional anti-H. Pylori therapy versus conventional therapy supplemented with S. boulardii and L. reuteri DSMZ 17648. For this aim, a total of 156 patients were included in the current study; and patients positive for H. Pylori infection (n =156) were randomly assigned to 3 groups: 52 patients (Group P) received conventional quadruple therapy plus L. reuteri, 52 patients (Group S) received conventional quadruple therapy plus S. boulardii daily, for 2 weeks, and 52 patients were in the control group (Group C). At the end of the treatment period, all the subjects continued to take proton pump inhibitor (PPI) alone for 14 days, and then, no medication was given for 2 weeks again. During follow-up, gastrointestinal symptoms were assessed using an evaluation scale (Glasgow dyspepsia questionnaire (GDQ)), and adverse events were assessed at 7, 14, 21, and 28 days. As a result, eradication therapy was effective for 94.2% of subjects in Group S, 92.3% of subjects in Group P, and 86.5% of subjects in the control group, with no differences between treatment arms. In Group S, the chance of developing symptoms of nausea (OR=2.74), diarrhea (OR=3.01), headache (OR=10.51), abdominal pain (OR=3.21), and anxiety (OR=3.58) was significantly lower than in the control group (p<0.05).Conclusion: In general, our findings revealed that the use of probiotic supplements containing S. boulardii or Lactobacillus reuteri (DSMZ 17648 strain) improved the eradication rate of H. Pylori infection, but it was not statistically significant. Therefore, it is recommended to conduct future research with a larger sample size to investigate the effect of S. boulardii supplementation on eradicating H. pylori infection and reducing treatment side effects.Trial registration: IRCT20200106046021N1, this trial was registered on Jan 14, 2020.

2019 ◽  
Vol 91 (8) ◽  
pp. 28-33 ◽  
Author(s):  
A M Veliev ◽  
I V Maev ◽  
D N Andreev ◽  
D T Dicheva ◽  
A V Zaborovskii ◽  
...  

Aim. Evaluation of the efficacy and safety of quadrupletherapy without bismuth (concomitant therapy) in patients with Helicobacter pylori - associated gastric ulcer and duodenal ulcer in the framework of a comparative research in the population of patients in Russia. Materials and methods. A prospective randomized trial was conducted, which included 210 patients with H. pylori - associated gastric/duodenal ulcer without complications. During the process of randomization, the patients were divided into three equal groups (n=70) depending on the prescribed 10-day scheme of eradication therapy (ET): the first group received the classic triple scheme (Omeprazole 20 mg 2 times a day, Amoxicillin 1000 mg 2 times a day and Clarithromycin 500 mg 2 times a day); the second group received quadruple therapy with bismuth drugs (Omeprazole 20 mg 2 times a day, Tetracycline 500 mg 4 times a day, Metronidazole 500 mg 3 times a day, Bismuth subcitrate potassium 120 mg 4 times a day); the third group received quadruple therapy without bismuth - concomitant therapy (Omeprazole 20 mg 2 times a day, Amoxicillin 1000 mg 2 times a day, Clarithromycin 500 mg 2 times a day and Metronidazole 500 mg 2 times a day). Diagnostics of H. pylori infection during screening and control of eradication was carried out via the fast urease biopsy sample test and urea breath test system. Control of the effectiveness of ET of the microorganism was carried out not earlier than 4 weeks after the end of the treatment. During the course of therapy, the frequency of development of side effects was assessed using a special questionnaire. Results and discussion. The effectiveness of triple therapy was 72.8% (ITT; 95% CI of 62.17-83.54) and 78,4% (PP; 95% CI 68.19-88.72); quadruple therapy with the preparation of bismuth - 80.0% (ITT; 95% CI 70.39-89.6) and 84,8% (PP; 95% CI, 75.96-93.73); quadruple therapy without bismuth - concomitant therapy - 84.2% (ITT; 95% CI 75.54-93.02) and 92.1% (PP; 95% CI 85.43-98.94). Quadruple therapy without bismuth was reliably more effective than the classical triple therapy in the PP selection (p=0.044883). Statistical analysis showed a tendency to poorer effectiveness of ET in patients who had previously used antibiotic therapy (OR 0.4317; 95% CI 0.1776-1.049), and in individuals with a rapid metabolism genotype - CYP2C19*1/*1 (OR 0.12; 95% CI 0.005848-2.4624). The frequency of development of side effects during the use of triple therapy was 18.5% (95% CI of 9.23-27.91), when using quadruple therapy with bismuth - 20.0% (95% CI 10.39-29.6), and with the use of quadruple therapy without bismuth - concomitant therapy - 24.2% (95% CI 13.98-34.58). Conclusion. This prospective randomized study demonstrated the high efficiency of quadruple therapy without bismuth (concomitant therapy) in the framework of eradication of H. pylori infection in Russia.


Author(s):  
Maria Pina Dore ◽  
Stefano Bibbò ◽  
Giovanni Mario Pes ◽  
Ruggero Francavilla ◽  
David Y. Graham

Background. Meta-analyses involving >4000 subjects with probiotics added to antimicrobial Helicobacter pylori eradication therapy have reported a mean increase in the eradication rate of 12 to 14%. It is unclear how to translate that result into clinical practice. Aim. To evaluate whether administration of Lactobacillus reuteri plus a PPI without antibiotics would eradicate H. pylori infections. Methods. This was a double-blind placebo-controlled randomized 2-site study of L. reuteri (Gastrus®) at a dose of 2 × 108 CFU, 7 times per day, or matching placebo plus 20 mg pantoprazole b.i.d. for 4 weeks. Cure was defined by negative 13C-UBT, 4 weeks after therapy. Sample size required ≥50% cure rates for using probiotics as a clinically useful monotherapy. Results. Recruitment was halted after 56 subjects because of the low cure rate; there were 8 dropouts; 48 subjects completed therapy (71% women, average age 49 years). The cure rates per protocol were 3/24 (12.5%; 95% CI 2.6–32%) with L. reuteri vs. 1/24 (4.1%) with placebo. Side effects (most often diarrhea) occurred infrequently (in 5/28 vs. 3/28; active vs. placebo therapy) (P=0.53). Conclusion. L. reuteri plus a PPI therapy was unable to provide a clinically important rate of H. pylori eradication. The cure rate albeit low (12.5%) was essentially identical to that achieved when probiotics were added to antibiotic therapy. The incremental improvement was additive and independent of antimicrobial resistance or antibiotics use. Probiotics can reliably increase the cure rate to ≥90% only in regimens achieving cure rates of ∼80%. This trial is registered with NCT03404440.


2016 ◽  
Vol 50 (1) ◽  
pp. 38
Author(s):  
Fransisca Theresia Aryani ◽  
Agus Firmansyah ◽  
Abdul Latief

Background Helicobacter pylori (H. pylori) infection is thought to be the etiology of chronic gastritis, peptic ulcer, and risk factor for gastric cancer. Management of H. pylori infection in children is associated with several problems such as compliance to therapy, untolerated side effects, and antibiotic resistance. Probiotic is reported to give beneficial effect in the management of H. pylori infection and there is no study yet on the effect of probiotic in eradication of H. pylori infection in Indonesian children.Objectives To study the effect of additional probiotic in the standard therapy on the rate of H. pylori infection eradication in children and its side effect.Methods This was a double blind randomized controlled trial performed in 23 children with H. pylori infection at Kampung Melayu and Rawa Bunga District. The diagnosis was determined based on Helicobacter pylori stool antigen test (HpSA). Subjects were randomly assigned to either receive receive amoxiycilin, clarithromycin, omeprazole, and probiotic (2 x 109 cfu of Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12) or amoxicillin, clarithromycin, omeprazole dan placebo (maltodextrin). HpSA examination was evaluated again after 2 weeks of therapy.Results Two of 13 subjects in the treatment group and 6 of 10 subjects in the control group experienced side effects. Eradication rate in the treatment group is higher than the control group (13/13 vs 7/10) but the correlation between additional probiotic with the eradication rate of H. pylori is not statistically significant.Conclusions Probiotic can reduce the incidence of side effects due to antibiotic used in H. pylori eradication (2/13 vs 6/10, p < 0.012). [Paediatr Indones. 2010;50:38-41].


Nutrients ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 3171
Author(s):  
Eric Guillemard ◽  
Marion Poirel ◽  
Florent Schäfer ◽  
Laurent Quinquis ◽  
Caroline Rossoni ◽  
...  

Helicobacter pylori (Hp) eradication therapy alters gut microbiota, provoking gastrointestinal (GI) symptoms that could be improved by probiotics. The study aim was to assess the effect in Hp patients of a Test fermented milk containing yogurt and Lacticaseibacillus (L. paracasei CNCM I-1518 and I-3689, L. rhamnosus CNCM I-3690) strains on antibiotic associated diarrhea (AAD) (primary aim), GI-symptoms, gut microbiota, and metabolites. A randomised, double-blind, controlled trial was performed on 136 adults under 14-day Hp treatment, receiving the Test or Control product for 28 days. AAD and GI-symptoms were reported and feces analysed for relative and quantitative gut microbiome composition, short chain fatty acids (SCFA), and calprotectin concentrations, and viability of ingested strains. No effect of Test product was observed on AAD or GI-symptoms. Hp treatment induced a significant alteration in bacterial and fungal composition, a decrease of bacterial count and alpha-diversity, an increase of Candida and calprotectin, and a decrease of SCFA concentrations. Following Hp treatment, in the Test as compared to Control group, intra-subject beta-diversity distance from baseline was lower (padj = 0.02), some Enterobacteriaceae, including Escherichia-Shigella (padj = 0.0082) and Klebsiella (padj = 0.013), were less abundant, and concentrations of major SCFA (p = 0.035) and valerate (p = 0.045) were higher. Viable Lacticaseibacillus strains were detected during product consumption in feces. Results suggest that, in patients under Hp treatment, the consumption of a multi-strain fermented milk can induce a modest but significant faster recovery of the microbiota composition (beta-diversity) and of SCFA production and limit the increase of potentially pathogenic bacteria.


2016 ◽  
Vol 73 (11) ◽  
pp. 1044-1049 ◽  
Author(s):  
Sasa Grgov ◽  
Tomislav Tasic ◽  
Biljana Radovanovic-Dinic ◽  
Daniela Benedeto-Stojanov

Background/Aim. Some studies suggest the benefit of applying different probiotic strains in combination with antibiotics in the eradication of Helicobacter pylori (H. pylori) infection. The aim of this study was to evaluate the effect of co-administration of multiple probiotic strains with triple H. pylori eradication therapy. Methods. This prospective study included 167 patients with dyspeptic symptoms and chronic gastritis who were diagnosed with H. pylori infection and randomized into two groups. The group I of 77 patients underwent triple eradication therapy, for 7 days, with lansoprazole, 2 ? 30 mg half an hour before the meal, amoxicillin 2 ? 1.000 mg per 12 hours and clarithromycin 2 ? 500 mg per 12 hours. After the 7th day of the therapy, lansoprazole continued at a dose of 30 mg for half an hour before breakfast for 4 weeks. The group II of 90 patients received the same treatment as the patients of the group I, with the addition of the probiotic cultures in the form of a capsule comprising Lactobacillus Rosell-52, Lactobacillus Rosell-11, Bifidobacterium Rosell-1755 and Saccharomyces boulardii, since the beginning of eradication for 4 weeks. Eradication of H. pylori infection control was performed 8 weeks after the therapy by rapid urease test and histopathologic evaluation of endoscopic biopsies or by stool antigen test for H. pylori. Results. Eradication of H. pylori infection was achieved in 93.3% of the patients who received probiotics with eradication therapy and in 81.8% of patients who were only on eradication therapy without probiotics. The difference in eradication success was statistically significant, (p < 0.05). The incidence of adverse effects of eradication therapy was higher in the group of patients who were not on probiotic (28.6%) than in the group that received probiotic (17.7%), but the difference was not statistically significant. Conclusion. Multiple probiotic strains addition to triple eradication therapy of H. pylori achieves a significantly better eradication success, with fewer side effects of antibiotics.


Author(s):  
Rukshana Shamshu ◽  
Jayasree Vaman ◽  
Nirmala C.

Background: This study has been designed to assess the effectiveness of the probiotic strains having Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 in the management of lower genital infections (bacterial vaginosis and candidiasis) as an integral therapy with antibiotics.Methods: Double blind, randomized placebo controlled study in women between 18-45 years attending Sree Avittom Thirunal Hospital (SATH), Government Medical College, Thiruvananthapuram, India with symptoms of bacterial vaginosis and vulvovaginal candidiasis. Women giving consent were given probiotics along with conventional antibiotics and were followed up over a period of two months. Outcome is measured as percentage of women showing a score of less than 4 at the end of thirty days of treatment, and sixty days of treatment in the test and control group in the case of bacterial vaginosis and no discharge and absence of hyphae and pseudohyphae in wet smear and gram stain in case of candidiasis.Results: Out of 42 women studied, 32 had bacterial vaginosis and 10 had vulvovaginal candidiasis. 81.3% women with BV had a normal vaginal picture after sixty days of treatment as compared to placebo which was only 31.3%. The p value is 0.004 which is significant. In the treatment of VC, the percentage of women cured was the same in both probiotic and placebo group.Conclusions: In the treatment of bacterial vaginosis, addition of probiotics to the conventional antibiotics can improve the cure rate of bacterial vaginosis and reduce the rate of recurrences. In the treatment of vulvovaginal candidiasis, addition of probiotics to the conventional antifungal did not have a significant improvement.


2021 ◽  
Vol 8 ◽  
Author(s):  
Yuchong Zhao ◽  
Yilei Yang ◽  
Aruna ◽  
Jun Xiao ◽  
Jun Song ◽  
...  

Background: Whether probiotics helped the Helicobacter pylori (H. pylori) eradication was still highly controversial. The non-bacterial Saccharomyces boulardii (S. boulardii) has demonstrated its efficacy in the treatment of antibiotic-associated and infectious diarrhea. We aimed to evaluate the effects of S. boulardii combined with quadruple therapy for H. pylori eradication and associated side effects.Methods: Three hundred and sixty H. pylori-infected patients were recruited in this multicenter, randomized controlled trial. The patients who underwent H. pylori eradication treatment were randomized in a ratio of 1:1 into two separate groups that received standard quadruple therapy (Group A) and quadruple therapy plus S. boulardii sachets (Group B) for 14 days. The everyday medication and side-effect records were collected for compliance and adverse effect analysis. All patients accepted 13C/14C-urea breath tests 4 weeks after the therapy completion.Results:Saccharomyces boulardii and quadruple therapy-combined intervention significantly reduced the incidences of overall side effects (27.8 vs. 38.5%, p = 0.034) and diarrhea (11.2 vs. 21.2%, p = 0.012) in Group B compared with quadruple therapy alone in Group A, especially reduced the diarrhea duration (5.0 days vs. 7.7 days, p = 0.032) and incidence of severe diarrhea (4.7 vs. 10.1%, p = 0.040). Intention-to-treat (ITT) analysis and per-protocol (PP) analysis both indicated no statistical differences of eradication rate between Groups A and B (ITT: 82.7 vs. 85.8%, p = 0.426; PP: 89.7 vs. 94.2%, p = 0.146). The joint use of S. boulardii and quadruple therapy markedly improved the overall pre-eradication alimentary symptoms (hazard ratio (HR): 2.507, 95% CI: 1.449–4.338) recovery.Conclusion:Saccharomyces boulardii ameliorated H. pylori eradication-induced antibiotic-associated side effects especially reduced the incidence of severe diarrhea and the duration of diarrhea. However, there was no significant effect of S. boulardii on the rate of H. pylori eradication.Trial Registration: The protocol had retrospectively registered at ClinicalTrails.gov, Unique identifier: NCT03688828, date of registration: September 27, 2018; https://clinicaltrials.gov/show/NCT03688828


2020 ◽  
Author(s):  
Bo Tang ◽  
Li Tang ◽  
Cheng Huang ◽  
Chuan Tian ◽  
Ling Chen ◽  
...  

Abstract Background: Helicobacter pylori (H. pylori) eradication therapy may lead to the perturbation of gut microbiota. The role of probiotics in gut microbiota during eradication therapy is still debated. Design: This was a multicentre, open-label, randomised trial done at seven hospitals in China. 162 patients were enrolled, 79 patients were randomly divided into group A (bismuth quadruple therapy), and 83 patients were randomly subjected into group B (bismuth quadruple therapy supplemented with Medilac-S). Faecal samples were collected before treatment and 2 weeks, 4 weeks, 6 weeks, and 8 weeks after eradication therapy. Gut microbiota was analyzed by 16S rRNA high-throughput sequencing. This trial is complete and registered with Chinese Clinical Trial Registry (Chictr.org.cn, ChiCTR1900022116). Results: The eradication rates of group A and group B were 82.43% and 87.01%, respectively (P>0.05). Compared with baseline, alpha and beta diversity was significantly altered 2 weeks after eradication in both group A and group B, which was restored at week 8. There were no significant differences in alpha and beta diversity between the two groups. Bismuth quadruple therapy resulted in enrichment of some detrimental bacteria taxa such as Klebsiella and Streptococcus that were not recovered by week 8. Probiotics supplementation could rapidly restore the taxa levels of Klebsiella and Streptococcus by week 4 after eradication, and increase the beneficial taxa of Bacillus and Lactobacillales. Functional analysis revealed that lipopolysaccharide biosynthesis and polymyxin resistance pathways were significantly enriched after eradication therapy, while probiotics supplementation mainly enriched the cofactors and vitamins metabolism pathways. Several detrimental taxa were identified to be correlated with features of older age, alcohol use and high BMI, while probiotics supplementation could effectively restore the adverse impact in patients with these characteristics.Conclusion: Probiotics supplementation is beneficial for patients during H. pylori eradication, especially for patients with older age, alcohol drinking, and obesity, which might obtain the maximum benefits.


2021 ◽  
Vol 49 (11) ◽  
pp. 030006052110606
Author(s):  
Hussam Murad ◽  
Misbahuddin Rafeeq ◽  
Mahmoud Mosli ◽  
Mamdouh Gari ◽  
Mohammed Basheikh

Objective To investigate the effect of sequential Helicobacter pylori eradication therapy on serum osteoprotegerin levels in patients with H. pylori infection and co-existing inflammatory bowel disease (IBD). Methods Three groups of patients were involved in this observational cross-sectional study: IBD (n = 83), H. pylori infection (HP, n = 68), and H. pylori infection with co-existing IBD (HP + IBD, n = 52). These groups were compared with a normal control group (NC, n = 50). Serum osteoprotegerin, serum bone alkaline phosphatase (BALP), and fecal calprotectin (FC) levels were measured. Results Serum osteoprotegerin levels were significantly correlated with the simple endoscopic score for Crohn’s disease and Mayo score for ulcerative colitis. The receiver operating characteristic analysis of osteoprotegerin revealed high values for the area under the curve, sensitivity, and specificity. Discriminant analysis illustrated that osteoprotegerin levels significantly differentiated patients with IBD from healthy controls. Osteoprotegerin and FC levels distinguished the IBD and HP + IBD groups from the NC and HP groups. Conclusions Sequential eradication therapy did not affect serum osteoprotegerin levels in patients with H. pylori infection and co-existing IBD. Serum osteoprotegerin elevation might be a marker for IBD development in patients with past or current H. pylori infection.


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