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Not yet recruitingNCT07425704Updated Mar 18, 2026

Probiotics, Antibiotics and the Post-Antibiotic Microbiota

An interventional study of Lab4S and Placebo in Probiotic and Microbiome, sponsored by Cultech Ltd. Not yet recruiting at 1 site in Bulgaria. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Cultech Ltd · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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

02

Conditions studied

  • Probiotic
  • Microbiome
03

In context

Lead sponsor

Cultech Ltd is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adults, aged 18-40.
  2. Been prescribed an oral dose of cephalosporin antibiotic lasting 5 - 10 days.
  3. Willing to provide stool samples and, for women, vaginal samples.
  4. Willing to avoid consumption of any other probiotic capsules/tablets during the study.

Exclusion criteria

Exclusion Criteria:

  1. If antibiotics prescribed are intended to treat any gastrointestinal or vaginally related issue.
  2. Any antibiotic intake within the last 3 months.
  3. Immunodeficient or undergoing immunosuppressive therapy.
  4. Currently diagnosed with diabetes/cardiovascular disease/cancer/dementia.
  5. Any unexplained loss of weight in recent months.
  6. Known to be pregnant or \<3 months postpartum.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Active

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

    Dietary Supplement: Lab4S

  • Placebo comparator
    Placebo

    Placebo

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementLab4S

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

  • Dietary supplementPlacebo

    Placebo

06

What researchers measure

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)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07425704
Lead sponsor
Cultech Ltd
Responsible party
Sponsor
First posted
Feb 23, 2026
Start date
Apr 13, 2026 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Mar 18, 2026

Study contacts

Maya Dabcheva
Contact
maya.dabcheva@comac-medical.com
+359887113036

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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