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NCT Number: NCT07425704

Probiotics, Antibiotics and the Post-Antibiotic Microbiota

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

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Key information

Conditions

Probiotic Microbiome

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lab4S

Dietary Supplement

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

Placebo

Dietary Supplement

Placebo

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.

    Time frame: One month post antibiotic treatment/ intervention (30 days)

    A daily gastrointestinal/Vaginal health symptom record sheet which involves ticking off symptoms is present.

  2. Bowel habit diary to measure gastrointestinal health post Intervention

    Time frame: One month post antibiotic treatment/ intervention (30 days)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Maya Dabcheva

CONTACT

[email protected]

+359887113036

Sponsors and collaborators

Lead sponsor

Cultech Ltd

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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