MedTrace Logo

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

NCT04786938 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2021-10-04

No results posted yet for this study

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

Interventions

DRUG

Saccharomyces Boulardii-Containing Product in Oral Dose Form

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

Sponsors & Collaborators

  • Universidad Tecnológica Equinoccial

    collaborator OTHER

  • Biocodex

    collaborator INDUSTRY

  • Universidad San Francisco de Quito

    lead OTHER

Principal Investigators

  • Paúl A Cárdenas, PhD · Universidad San Francisco de Quito

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-07
Primary Completion
2017-06-09
Completion
2017-06-09

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04786938 on ClinicalTrials.gov