Evidence map›Paper›PMID 35255819›Full record

Trial reportBMC gastroenterology2022

Investigating the effect of quadruple therapy with Saccharomyces boulardii or Lactobacillus reuteri strain (DSMZ 17648) supplements on eradication of Helicobacter pylori and treatments adverse effects: a double-blind placebo-controlled randomized clinical trial.

Nooshin Naghibzadeh, Fatemeh Salmani, Samira Nomiri, Tahmine Tavakoli

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 3 pooled it
5.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Efficacy and safety ofFrontiers in cellular and infection microbiology · 2025
    Pooled it
  2. The effect of supplementing withFrontiers in medicine · 2024
    Pooled it
  3. Pooled it
  4. Trial
  5. Frontiers in cellular and infection microbiology · 2022
    Trial
  6. Beyond Antibiotics: Alternative Strategies TargetingExpert reviews in molecular medicine · 2026
    Review
  7. Article
  8. Development of a Dihydrofolate Reductase Selection System forInternational journal of molecular sciences · 2025
    Article
  9. Efficacy of Pyloshot in combination with standard four-drug antimicrobial treatment forJGH open : an open access journal of gastroenterology and hepatology · 2024
    Article
  10. An Update on Eradication ofMiddle East journal of digestive diseases · 2024
    Review
  11. Antibiotics (Basel, Switzerland) · 2024
    Review
  12. Probiotics and autoprobiotics for treatment ofWorld journal of clinical cases · 2023
    Review
  13. Review
  14. Natural Ingredients to Improve Immunity.Pharmaceuticals (Basel, Switzerland) · 2023
    Review
  15. Frontiers in cellular and infection microbiology · 2023
    Review
  16. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 1 country.

Nooshin NaghibzadehGastroenterology Department, Faculty of Medicine, Birjand University of Medical Science, Birjand, Iran.
Fatemeh SalmaniEpidemiology and Biostatistics Department, Social Determinants of Health Research Center, Faculty of Health, Birjand University of Medical Sciences, Birjand, Iran.
Samira NomiriClinical Biochemistry Department, Faculty of Medicine, Birjand University of Medical Sciences, Birjand, Iran.
Tahmine TavakoliGastroenterology Department, Faculty of Medicine, Birjand University of Medical Science, Birjand, Iran. tahminetavakoli95238@yahoo.com.
Birjand University of Medical Sciences · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe goal of this study was to investigate the effects of treatment with Saccharomyces boulardii and Lactobacillus reuteri on the eradication of Helicobacter pylori and Adverse effects (AEs) of the treatment.

resultsThis study was a double-blind, randomized, placebo-controlled trial. And, eradication of H. pylori was reported comparing quadruple therapy include of PPI (proton pomp inhibitor), bismuth subcitrate, clarithromycin, and amoxicillin versus quadruple 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 AEs were assessed at 7, 14, 21, and 28 days. As a result, all patients completed the treatment protocol in all groups by the end of the study. Additionally, 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).

conclusionS. boulardii could significantly reduce some AEs of H. pylori eradication therapy, but effectiveness of Lactobacillus reuteri on these cases was not significant. It is recommended to conduct the future research with larger sample size in order to investigate the effect.

trial registrationIRCT20200106046021N1, this trial was registered on Jan 14, 2020.

Indexed as

Helicobacter InfectionsHelicobacter pyloriLimosilactobacillus reuteriSaccharomyces boulardiiAmoxicillinAnti-Bacterial AgentsDrug Therapy, CombinationHumansProton Pump InhibitorsTreatment OutcomeAmoxicillinAnti-Bacterial AgentsProton Pump InhibitorsAdverse effectsEradication rateHelicobacter pyloriLactobacillus reuteriSaccharomyces boulardiiSequential treatment

Identifiers

PMID35255819
PMCPMC8903632
OpenAlexW4220835942

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.