Probiotics, Antibiotics and the Post-Antibiotic Microbiota
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCultech Ltd
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Lab4S
Dietary supplementProbiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day
Placebo
Dietary supplementPlacebo
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: ActiveActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
1
Questionnaire of gastrointestinal/Vaginal health to measure gastrointestinal/vaginal health post intervention.
A daily gastrointestinal/Vaginal health symptom record sheet which involves ticking off symptoms is present.
Time frame
One month post antibiotic treatment/ intervention (30 days)2
Bowel habit diary to measure gastrointestinal health post Intervention
A bowel habit diary questionnaire to be completed for every attempted bowel motion during the study. Questions include; 1. Were you able to pass a stool?, 2. Did you feel an urgent need to pass the bowel motion?, 3. Did you strain to start the bowel motion?, 4. Were you left with a feeling of incomplete evacuation?, 5. Please rate the appearance of your bowel motion using the bristol stool score (1-7).
Time frame
One month post antibiotic treatment/ intervention (30 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: