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Modification of the COVID-19 Vaccine Response by an Intervention on the Intestinal Flora

NCT05195151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 592

Last updated 2025-01-15

No results posted yet for this study

Summary

The elderly, who are often in poorer health, have been particularly affected by the COVID-19 pandemic. Recent study results show that while vaccines have been very effective in the short term, protection for the elderly may not be sufficient 6 months after the 2nd dose. Some countries have started to offer a 3rd dose. We are considering acting on the intestinal flora of the elderly (which is often unbalanced) in order to increase the effectiveness of the vaccination. Indeed, it has been demonstrated that probiotics (which can rebalance the intestinal flora) significantly increase the production of antibodies after vaccination against the flu virus. Our hypothesis is that taking probiotics one month before and one month after the 4th dose of COVID vaccine would result in longer lasting vaccine protection in seniors. This study will include 688 seniors, aged 65-89 years, who have not had COVID-19, who have received 3 doses of an mRNA vaccine and who will accept a another booster dose . All participants will take 1 capsule/day (probiotics or placebo) for 1 month and in the middle of this period will receive a booster dose. On 3 occasions (inclusion, 3 months and 6 months post-vaccination), they will prick their fingertip and express the drop of blood on a blotting paper. They will mail this dried blood sample in an envelope for antibody testing in Quebec Research center. A subgroup of 100 participants willing to travel at CHUS' Clinical Research Center for 2 times (inclusion visit and final visit) will be invited to do a blood test. The investigators expect to reduce the number of seniors who are poorly protected by a booster dose 6 months after the injection. If successful, this approach could quickly be implemented worldwide as probiotics have few side effects and are affordable.

Conditions

Interventions

DIETARY_SUPPLEMENT

Taking capsule containing probiotics or placebo

The probiotics capsule containing two strains of probiotics.

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    collaborator OTHER

  • Université de Sherbrooke

    lead OTHER

Principal Investigators

  • Jean-Charles Pasquier, Dr · Université de Sherbrooke

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-10
Primary Completion
2024-07-17
Completion
2024-07-17

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT05195151 on ClinicalTrials.gov