ProbioticNCT07425704
Probiotics, Antibiotics and the Post-Antibiotic Microbiota
A study testing Lab4S in people with Probiotic and Microbiome, run by Cultech Ltd at 1 site in Bulgaria.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Probiotic, Microbiome
- What is being tested?
- Lab4S
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteBulgaria
- Study dates
- 13 Apr 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bulgaria1 site
Comac Medical
Sofia
Maya Dabcheva, +359887113036, maya.dabcheva@comac-medical.com
About this study
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
- Conditions
- Probiotic, Microbiome
- Being tested
- Lab4S, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lab4SDietary supplement
Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day Receives: Dietary Supplement: Lab4S |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in microbiome composition post antibiotic/interventional treatment through Shotgun Metagenomics
Measured: 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.
A daily gastrointestinal/Vaginal health symptom record sheet which involves ticking off symptoms is present.
Measured: One month post antibiotic treatment/ intervention (30 days)
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).
Measured: One month post antibiotic treatment/ intervention (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start13 Apr 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cultech Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425704
- Sponsor's protocol ID
- PAPAM
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics, Antibiotics and the Post-Antibiotic Microbiota
- ClinicalTrials.gov ID
- NCT07425704
- Acronym / sponsor ID
- PAPAM
- Conditions
- Probiotic, Microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cultech LtdIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Dietary Supplement: Lab4SProbiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lab4SProbiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day | Dietary supplement | Active |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
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)
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lab4S in people with Probiotic and Microbiome, run by Cultech Ltd at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Dabcheva (+359887113036, maya.dabcheva@comac-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.