Effect of a Probiotic or Postbiotic on Gut Microbiome During Antibiotic Treatment

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

This study assesses the effects of a probiotic or postbiotic on gut microbiome during antibiotic treatment.

The current study aims to assess the changes in microbiome composition in healthy adults receiving antibiotic treatment, and concomitantly a probiotic or postbiotic. The trial will be run in Greece, and will recruit healthy adults from the general population.

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.