Probiotics, Antibiotics and the Post-Antibiotic Microbiota
1 other identifier
interventional
50
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2026
CompletedFirst Posted
Study publicly available on registry
February 23, 2026
CompletedStudy Start
First participant enrolled
April 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
March 18, 2026
March 1, 2026
6 months
February 16, 2026
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in microbiome composition post antibiotic/interventional treatment through Shotgun Metagenomics
From date of randomization until the end of the study (90 days)
Secondary Outcomes (2)
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)
Study Arms (2)
Active
ACTIVE COMPARATORProbiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Adults, aged 18-40.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cultech Ltdlead
Study Sites (1)
Comac Medical
Sofia, Bulgaria
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2026
First Posted
February 23, 2026
Study Start
April 13, 2026
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share