Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Probiotic or Postbiotic to Support Gut Microbiome During Antibiotics

Official title: Assessment Of Gut Microbiome Changes During Antibiotic Treatment With Probiotic, Postbiotic Or Placebo: A Randomized, Triple-blind, Placebo-controlled Pilot Study.

Run by The Archer-Daniels-Midland Company · NCT07594860 · Data updated 2026-11-12

This study tests whether a probiotic or postbiotic can help maintain a healthy gut microbiome in healthy adults who are taking antibiotics.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment126 (estimated)
SponsorThe Archer-Daniels-Midland Company
Industry-sponsored
Locations1 site (Thessaloniki)
StatusRecruiting
StartedAugust 27, 2026
Main results expectedMay 31, 2027
Study endsMay 31, 2027
Registry record updatedOctober 28, 2026
Trial IDNCT07594860 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18-65 who are healthy by medical history and exam, not pregnant, and not changing their diet during the study.

Probably not a fit

Individuals with underlying health conditions, current medication changes, or contraindications to study products may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study in healthy adults in Greece will compare probiotic, postbiotic, and placebo during antibiotic treatment. Researchers will examine changes in gut microbiome composition and related factors such as antibiotic resistance genes. Participants will be randomized to one of the three arms and will provide biological samples and health data throughout the course of treatment. The trial is sponsored by Archer Daniels Midland Company with NEXT CRO as collaborator and will be conducted at the General Hospital of Thessaloniki Papageorgiou. The aim is to understand whether alternative microbial therapies can mitigate antibiotic-induced dysbiosis.

Why it matters

Potential benefit: If successful, participants may experience better-maintained gut microbiome balance during antibiotic use, which could reduce dysbiosis-related symptoms.

How similar studies have gone: Previous work in this area has shown potential for probiotics or postbiotics to influence the gut microbiome during antibiotics, but results vary by strain and context.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

Participants meeting ALL of the following criteria will be recruited for the study:

* Males and females aged ≥18 to ≤ 65 years; if female, either not of childbearing potential or using a medically approved method of birth control and willing to take a pregnancy test at screening.
* Body mass index (BMI) 18.5-29.9 kg/m².
* Healthy as determined by medical history and physical examination.
* Agreed not to change current dietary habits during the course of the study.
* Able to attend study visits, comply with study requirements (consumption of study medications, especially biological sample collection procedures, and study visit schedule) and provide reliable and complete data regarding AEs/SAEs and PROs.
* Have been informed and have given written consent for the use of their data in accordance with local regulations before study inclusion.

Exclusion Criteria:

Participants meeting ANY of the following criteria will be excluded from the study:

* Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the study.
* People on vegetarian or vegan diet; People on special diet (e.g. Ducan, Keto, etc.)
* BMI ≥ 30 kg/m² or \<18.5 kg/m².
* History of intake of antibiotics, other probiotics, postbiotics, prebiotics, synbiotics, proton pump inhibitors, acid sequestrants (cholestyramine, Bile colestipol), within six months prior to the screening day.
* Participation in other clinical trials in the last 90 days prior to screening.
* Allergy to any penicillin antibiotic or any other beta-lactam agent (e.g. cephalosporin, carbapenem or monobactam).
* History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid.
* Active smokers or using any form of smokeless tobacco.
* Participants with substance abuse problems (within two years) defined as:

  * Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/ Nicotine dependence.
  * High-risk drinking as defined by the consumption of four or more alcohol-containing beverages on any day or eight or more alcohol-containing beverages per week for women and five or more alcohol-containing beverages on any day or 15 or more alcohol-containing beverages per week for men.
* Participants having clinically significant illnesses of cardiovascular, endocrine, immune, respiratory, hepato-biliary, kidney and urinary, haematological, musculoskeletal system and/or any inflammatory disorder, tumour, and other gastrointestinal diseases.
* Participants with a history of bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.
* Participants actively using GLP1 agonist drugs (Wegovy, Semiglutide etc.) or completed treatment with said medication less than 12 weeks before screening.
* Any condition that could, in the opinion of the Investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

Where it's running

  • General Hospital of Thessaloniki Papageorgiou
    Thessaloniki, Greece
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.