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Clinical Trials/NCT07425704
NCT07425704
Not yet recruiting
Not Applicable

Probiotics, Antibiotics and the Post-Antibiotic Microbiota

Cultech Ltd1 site in 1 country50 target enrollmentStarted: April 13, 2026Last updated:
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InterventionsLab4SPlacebo

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
50
Locations
1
Primary Endpoint
Changes in microbiome composition post antibiotic/interventional treatment through Shotgun Metagenomics
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

Antibiotic therapy can cause gastrointestinal dysbiosis and this study will assess the impact of probiotic supplementation on microbiological composition and functionality pre- and post- antibiotic therapy

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adults, aged 18-
  • •Been prescribed an oral dose of cephalosporin antibiotic lasting 5 - 10 days.
  • •Willing to provide stool samples and, for women, vaginal samples.
  • •Willing to avoid consumption of any other probiotic capsules/tablets during the study.

Exclusion Criteria

  • •If antibiotics prescribed are intended to treat any gastrointestinal or vaginally related issue.
  • •Any antibiotic intake within the last 3 months.
  • •Immunodeficient or undergoing immunosuppressive therapy.
  • •Currently diagnosed with diabetes/cardiovascular disease/cancer/dementia.
  • •Any unexplained loss of weight in recent months.
  • •Known to be pregnant or \<3 months postpartum.

Arms & Interventions

Active

Active Comparator

Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day

Intervention: Lab4S (Dietary Supplement)

Placebo

Placebo Comparator

Placebo

Intervention: Placebo (Dietary Supplement)

Outcomes

Primary Outcomes

Changes in microbiome composition post antibiotic/interventional treatment through Shotgun Metagenomics

Time Frame: From date of randomization until the end of the study (90 days)

Secondary Outcomes

  • Questionnaire of gastrointestinal/Vaginal health to measure gastrointestinal/vaginal health post intervention.(One month post antibiotic treatment/ intervention (30 days))
  • Bowel habit diary to measure gastrointestinal health post Intervention(One month post antibiotic treatment/ intervention (30 days))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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