Effect of Probiotics on the Fecal Resistome During Helicobacter Pylori Eradication Therapy

NCT04786938 | Completed Phase 4

• 1 other identifier: 16943
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Eradication therapy against Helicobacter pylori (Hp) carries adverse effects, such as altering the intestinal microbiota's structure and function and selecting commensals and pathogens resistant to antibiotics. This last undesirable effect turns the microbiota into a reservoir of resistance genes. Saccharomyces boulardii CNCM I-745 (Sb) can improve dysbiosis and reduce the abundance of multi-resistant bacteria. The objective of the current project is to characterize the resistome of individuals treated with anti-H. pylori therapy in the presence or absence of Sb in fecal samples. Applying metagenomics and using next-generation sequencing tools, the investigators seek to demonstrate the beneficial effect of Sb on the gut microbiota by reducing the abundance of resistance genes and characterizing bacteria modulated by this probiotic-yeast. The investigators expect to find an increase in the diversity and relative abundance of antibiotic resistance genes (ARGs) in the intestine of participants who did not receive Sb during Hp eradication therapy and one month after completing treatment. The increase in ARGs is probably correlated with the presence of Clostridia and Bacteroides.

Conditions

Gut Resistome

Keywords

Saccharomyces boulardii; eradication therapy; Helicobacter Pylori [H. Pylori]

Outcome Measures

Primary Outcomes (1)

• Modifications in the fecal resistome during a probiotic administration

  Changes in abundance and diversity of antimicrobial resistance genes in fecal micobiota from individuals treated against a H. pylori infection with Saccharomyces boulardii CNCM I-745 as an additional therapy to conventional treatment regimen.

  Participating patients were asked to provide three fecal samples during the study, the first before initiation of antibiotics, the second immediately after completion of antibiotics, and the last sample 1 month after finishing the treatment.

Study Arms (2)

Saccharomyces boulardii

EXPERIMENTAL

Conventional treatment (amoxicillin 1 g three times a day, tinidazole 1g four times a day, and omeprazole 40mg twice a day; n=34) plus S. boulardii CNCM I-745 (approximately 22.5 x109 CFU

Drug: Saccharomyces Boulardii-Containing Product in Oral Dose Form

No intervention

NO INTERVENTION

Conventional treatment (amoxicillin 1 g three times a day, tinidazole 1g four times a day, and omeprazole 40mg twice a day; n=34)

Interventions

Saccharomyces Boulardii-Containing Product in Oral Dose Form DRUG

S. boulardii CNCM I-745 (approximately 22.5 x109 CFU)

Saccharomyces boulardii

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with typical dyspepsia symptoms from whom an upper gastrointestinal endoscopy with biopsies was done for histopathological examination.

You may not qualify if:

• Pregnancy or lactation.
• Subjects diagnosed with another gastrointestinal disease such as inflammatory bowel disease and malabsorption syndromes.
• Subjects taking or are planning to take pre- pro- or symbiotic.
• Subjects that have received antibiotics in the last month for any reason.
• Subjects who have received corticosteroids chronically for any reason; have received medication to inhibit nutrient absorption; use of NSAID during the last month that cannot stop the treatment.

Sponsors & Collaborators

• Universidad San Francisco de Quito: lead
• Universidad Tecnológica Equinoccial: collaborator
• Biocodex: collaborator

Related Publications (1)

• Cardenas PA, Garces D, Prado-Vivar B, Flores N, Fornasini M, Cohen H, Salvador I, Cargua O, Baldeon ME. Effect of Saccharomyces boulardii CNCM I-745 as complementary treatment of Helicobacter pylori infection on gut microbiome. Eur J Clin Microbiol Infect Dis. 2020 Jul;39(7):1365-1372. doi: 10.1007/s10096-020-03854-3. Epub 2020 Mar 3.

  PMID: 32125555 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

Dosage Forms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Paúl A Cárdenas, PhD

  Universidad San Francisco de Quito

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor at the Institute of Microbiology

Model Details: A total of 72 H. pylori-positive patients were enrolled, and they were randomly assigned to group conventional (A) and group conventional plus S. boulardi (B). Patients in group A received 14-day triple therapy consisting of amoxicillin 1 g three times a day, tinidazole 1 g once a day, and omeprazole 40 mg twice a day. Patients in group B received triple therapy supplemented with S. boulardii CNCM I-745 (approximately 22.5 x 10\^9 CFU) for 14 days.

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: April 7, 2016
• Primary Completion: June 9, 2017
• Study Completion: June 9, 2017
• Last Updated: October 4, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: DNA sequences (raw reads): immediately following publication. No end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.