Probiotics, Antibiotics and the Post-Antibiotic Microbiota

March 16, 2026 updated by: Cultech Ltd
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Placebo
Active Comparator: Active
Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day
Dietary supplement: Lab4S
Probiotic containing lactic acid bacteria and Saccharomyces boulardii at a dose of 35 billion per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
From date of randomization until the end of the study (90 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
One month post antibiotic treatment/ intervention (30 days)
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.
One month post antibiotic treatment/ intervention (30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cultech Ltd

Collaborators

Comac Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 13, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • PAPAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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