Evidence map›Paper›PMID 41923280›Full record

ArticleHelicobacter

Real-World Effectiveness and Safety of Saccharomyces boulardii CNCM I-745 as Adjunct Therapy for Helicobacter pylori Eradication: Data From the European Registry on H. pylori Management (Hp-EuReg).

Olga P Nyssen, Laimas Jonaitis, Ángeles Pérez-Aísa, Bojan Tepes, Umud Mahmudov, Irina Voynovan, Samuel J Martínez-Domínguez, Luis Bujanda, Alfredo J Lucendo, Ludmila Vologzanina and 41 more

Registry-linked trialAbstract read
In one paragraph

Article in Helicobacter. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02328131 (European Registry on the Management of Helicobacter Pylori Infection), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT02328131 recruitingnot on this map

European Registry on the Management of Helicobacter Pylori Infection

TypeobservationalSponsorJavier P. GisbertRan2013 to 2034Enrolled10,000ConditionsH. Pylori Infection
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

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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

51 authors.

Olga P NyssenDepartment of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.ORCID https://orcid.org/0000-0002-4920-9310
Laimas JonaitisDepartment of Gastroenterology, Lithuanian University of Health Sciences, Kaunas, Lithuania.ORCID https://orcid.org/0000-0001-9086-3675
Ángeles Pérez-AísaDepartment of Gastroenterology, Hospital Universitario Costa del Sol, RICAPPS - Red de Investigación en Cronicidad, Atención Primaria y Prevención y Promoción de la Salud, Marbella, Spain.ORCID https://orcid.org/0000-0003-2974-1382
Bojan TepesDepartment of Gastroenterology, DC Rogaska, Slovenia.ORCID https://orcid.org/0000-0002-5616-4333
Umud MahmudovMemorial Hospital, Baku, Azerbaijan.ORCID https://orcid.org/0009-0002-8932-8928
Irina VoynovanA.S. Loginov Moscow Clinical Scientific Center, Moscow, Russia.
Samuel J Martínez-DomínguezDepartment of Gastroenterology, Hospital Clínico Universitario Lozano Blesa, Instituto de Investigación Sanitaria de Aragón (IIS Aragón), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Zaragoza, Aragon, Spain.ORCID https://orcid.org/0000-0003-0857-8117
Luis BujandaDepartment of Gastroenterology, Biodonostia Health Research Institute, Department of Medicine, Universidad del País Vasco (UPV/EHU), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), San Sebastián, Spain.
Alfredo J LucendoDepartment of Gastroenterology, Hospital General de Tomelloso, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Investigación Sanitaria de Castilla-La Mancha (IDISCAM), Tomelloso, Spain.
Ludmila VologzaninaGastrocentr, Perm, Russia.
Ana GarreDepartment of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.ORCID https://orcid.org/0009-0007-7960-3515
Frode LerangØstfold Hospital Trust, Grålum, Norway.
Sayar R AbdulkhakovKazan (Volga Region) Federal University, Kazan State Medical University, Kazan, Russia.
Matteo PavoniDepartment of Medical and Surgical Sciences, Sant'orsola-Malpighi University Hospital, Bologna, Italy.
Maja DenkovskiInterni Oddelek, Diagnostic Centre, Slovenia.ORCID https://orcid.org/0009-0007-6358-7282
Emin MammadovDepartment of Therapy, Azerbaijan State Advanced Training Institute for Doctors named after A. Aliyev, and Memorial Hospital, Baku, Azerbaijan.ORCID https://orcid.org/0000-0003-4629-350X
Mārcis LejaDepartment of Gastroenterology, Digestive Diseases Centre, Institute of Clinical and Preventive Medicine, University of Latvia, Riga, Latvia.ORCID https://orcid.org/0000-0002-0319-8855
Javier Tejedor-TejadaDepartment of Gastroenterology, Hospital Universitario de Cabueñes, Gijón, Asturias, Spain.ORCID https://orcid.org/0000-0002-3585-5733
Jose M HuguetDepartment of Gastroenterology, Hospital General Universitario de Valencia, Valencia, Spain.ORCID https://orcid.org/0000-0001-6486-1262
Galyna FadieienkoDepartments the Division for the Study of the Digestive Diseases and Its Comorbidity With Noncommunicable Diseases, Government Institution L.T. Malaya Therapy National Institute of NAMS of Ukraine, Kharkiv, Ukraine.
Ilchishina TatianaDepartment of Gastroenterology, SM-Clinic, Saint-Petersburg, Russia.
Manuel Pabón-CarrascoDepartment of Gastroenterology, Hospital Universitario Virgen de Valme, Sevilla, Spain.ORCID https://orcid.org/0000-0002-9011-3695
Aiman S SarsenbaevaDepartment of Gastroenterology, Chelyabinsk Regional Clinical Hospital, Chelyabinsk, Russia.
Oleg ZaytsevFirst Clinical Medical Centre, Kovrov, Russia.
Gülüstan BabayevaDepartment of Therapy, Azerbaijan State Advanced Training Institute for Doctors named after A. Aliyev, and Memorial Hospital, Baku, Azerbaijan.ORCID https://orcid.org/0000-0002-5805-3741
Jesús BarrioDepartment of Gastroenterology, Hospital Universitario Río Hortega, Gerencia Regional de Salud de Castilla y León (SACYL), Valladolid, Spain.ORCID https://orcid.org/0000-0001-7087-3921
Miguel AreiaDepartment of Gastroenterology, Portuguese Oncology Institute of Coimbra, Faculty of Medicine of the University of Porto (FMUP), RISE@CI-IPO (Health Research Network), Portuguese Oncology Institute of Porto (IPO Porto), Coimbra, Portugal.
Monica PeronaDepartment of Gastroenterology, Hospital Quirón Marbella, Marbella, Spain.
Óscar NúñezDepartment of Gastroenterology, Hospital Universitario La Moraleja, Faculty of Medicine, Universidad Francisco de Vitoria, Madrid, Spain.ORCID https://orcid.org/0000-0001-9130-746X
Antonietta G GravinaDepartment of Hepatogastroenterology, University of Study of Campania 'L.Vanvitelli', Naples, Italy.ORCID https://orcid.org/0000-0001-8049-0115
Sergey AlekseenkoDepartment of Hospital Therapy, Far Eastern State Medical University, Khabarovsk, Russia.ORCID https://orcid.org/0000-0003-1724-9980
Blas José Gómez RodríguezDepartment of Gastroenterology, Hospital Universitario Virgen Macarena, Sevilla, Spain.ORCID https://orcid.org/0000-0002-7428-032X
Quliyev Fərid Vidadi OğluNational Oncology Centre, Baku, Azerbaijan.
Inmaculada Ortiz-PoloDepartment of Gastroenterology, Hospital Universitario y Politécnico la Fe, Valencia, Spain.
Antonio Moreno LoroDepartment of Gastroenterology, Hospital Universitario Virgen del Rocío, Sevilla, Spain.ORCID https://orcid.org/0000-0003-4388-1058
György Miklós BuzásDepartment of Gastroenterology, Ferencváros Health Center, Budapest, Hungary.ORCID https://orcid.org/0000-0003-2926-1637
Boris D StarostinSaint-Petersburg State Budgetary Institution Healthcare City Policlinic 38, Saint-Petersburg, Russia.
Juozas KupcinskasDepartment of Gastroenterology, Lithuanian University of Health Sciences, Kaunas, Lithuania.
Dmitry S BordinDepartment of Pancreatic, Biliary and Upper Digestive Tract Disorders, A. S. Loginov Moscow Clinical Scientific Center, Department of Outpatient Therapy and Family Medicine, Tver State Medical University, Department of Propaedeutic of Internal Diseases and Gastroenterology, Russian University of Medicine, Moscow, Russia.ORCID https://orcid.org/0000-0003-2815-3992
Antonio GasbarriniDepartment of Internal Medicine and Gastroenterology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0002-6230-1779
Oleksiy GridnyevDepartments the Division for the Study of the Digestive Diseases and Its Comorbidity With Noncommunicable Diseases, Government Institution L.T. Malaya Therapy National Institute of NAMS of Ukraine, Kharkiv, Ukraine.ORCID https://orcid.org/0000-0003-4716-3520
Ricardo Marcos-PintoDepartment of Gastroenterology, Centro Hospitalar Do Porto, Instituto De Ciências Biomédicas de Abel Salazar, Universidade do Porto, Center for Research in Health Technologies and Information Systems (CINTESIS), Porto, Portugal.
Manuel Jiménez-MorenoDepartment of Gastroenterology, Hospital Universitario de Burgos, Burgos, Spain.ORCID https://orcid.org/0000-0002-3898-8101
Mónica Sánchez AlonsoDepartment of Gastroenterology, Hospital Universitario Santa Bárbara, Puertollano, Spain.
Virginia FloresDepartment of Gastroenterology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Irene ArteagoitiaDepartment of Gastroenterology, Hospital Universitario de Cruces, Spain.
Anna Cano-CatalàGastrointestinal Oncology, Endoscopy and Surgery (GOES) Research Group, Althaia Xarxa Assistencial Universitària de Manresa, Institut de Recerca i Innovació en Ciències de la Vida i de la Salut de la Catalunya Central (IRIS-CC), Manresa, Spain.
Pablo ParraDepartment of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.ORCID https://orcid.org/0009-0002-8597-2206
Leticia MoreiraDepartment of Gastroenterology, Hospital Clínic de Barcelona, Centro de Investigación Biomédica en Red en Enfermedades Hepáticas y Digestivas (CIBERehd), Institut D'investigacions Biomèdiques August pi i Sunyer (IDIBAPS), University of Barcelona, Barcelona, Spain.ORCID https://orcid.org/0000-0002-4518-8591
Javier P GisbertDepartment of Gastroenterology, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-Princesa), Universidad Autónoma de Madrid (UAM), and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.ORCID https://orcid.org/0000-0003-2090-3445
Hp‐EuReg investigators

Funding

Centro de Investigacioacute;n Biomeacute;dica en Red de Enfermedades Hepaacute;ticas y Digestivas (CIBERehd)European Helicobacter and Microbiota Study Group (EHMSG)European Union programme EU4Health 101101252European Union programme HORIZON 101095359Mayoly, Diasorin, Juviseacute;, Biocodex, and ZambonSpanish Association of GastroenterologyUK Research and Innovation 10058099
6 · The paper itself

Abstract

backgroundSaccharomyces boulardii CNCM I-745 (Sb) is one of the most widely used probiotics in clinical practice. The aim of this study was to assess the impact of adding Sb to Helicobacter pylori eradication therapy on treatment outcomes (effectiveness and safety) in routine European gastroenterology clinical practice. MATERIALS AND

methodsTreatment-naive cases from the European registry on H. pylori management (Hp-EuReg) collected from 2013 to 2023 at AEG-REDCap were analyzed. Effectiveness was assessed by modified intention-to-treat, by treatment and geographic regions. Multivariate analysis identified factors independently associated with eradication success and adverse event incidence.

resultsAmong 69,922 cases, probiotics were used in 16,528 (24%) treatments, of which 4404 (27%) included Sb. Sb use was significantly associated with an increase in effectiveness (OR = 2.32; 95% confidence interval, 1.38-4.03; p < 0.01) only when prescribed with concomitant therapy encompassing a proton pump inhibitor plus clarithromycin-amoxicillin-metronidazole. In addition, a significant reduction in the overall incidence of at least one adverse event was observed in the Sb group (OR = 0.803; 0.66-0.97; p < 0.05). Specifically, diarrhea, nausea, dyspepsia, abdominal pain, asthenia, anorexia, heartburn, and dysgeusia occurred significantly less frequently with Sb. Treatment compliance was high in both groups (with and without Sb).

conclusionsIn Europe, the addition of Sb to first-line regimens in clinical practice was associated with higher effectiveness when combined with concomitant therapy with clarithromycin-amoxicillin-metronidazole and with fewer overall adverse events, supporting its role as a beneficial adjunct in H. pylori eradication therapy. REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT02328131.

Indexed as

Anti-Bacterial AgentsHelicobacter InfectionsHelicobacter pyloriProbioticsSaccharomyces boulardiiAdultAgedAmoxicillinClarithromycinDrug Therapy, CombinationEuropeFemaleHumansMaleMetronidazoleMiddle AgedAmoxicillinAnti-Bacterial AgentsClarithromycinMetronidazoleProton Pump Inhibitorseffectivenesseradication therapyHelicobacter pylorihp‐EuRegprobioticssaccharomyces boulardiisafety

Identifiers

PMID41923280
PMCPMC13043801

What Socratic holds

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LicenceCC BY
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Registered trials

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 Socratic graph.