Not yet recruiting NCT07425704
Probiotics, Antibiotics and the Post-Antibiotic Microbiota
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lab4S, Placebo.
- Who it may be relevant to
- Registry conditions: Probiotic, Microbiome. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bulgaria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Dietary supplement Lab4S
Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day - Dietary supplement Placebo
Placebo
Primary outcome measures
- 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 outcome measures (2)
- Questionnaire of gastrointestinal/Vaginal health to measure gastrointestinal/vaginal health post intervention. [Time frame: One month post antibiotic treatment/ intervention (30 days)]
- Bowel habit diary to measure gastrointestinal health post Intervention [Time frame: One month post antibiotic treatment/ intervention (30 days)]
Eligibility criteria
Inclusion criteria
- 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
Bulgaria · 1 center
- Comac Medical — Sofia
Identifiers
NCT: NCT07425704 · PAPAM