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

NCT07594860 | Not Yet Recruiting

• 1 other identifier: CTB2024TN403
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Microbiome

Keywords

Antibiotic; Dysbiosis; Microbiome composition; Antibiotic Resistance Genes; Microbiome Recovery; Antibiotic Scarring; Probiotic; Postbiotic

Outcome Measures

Primary Outcomes (1)

• Changes in gut microbiome composition between baseline and day 14 as compared to placebo.

  To assess the effects of a probiotic or postbiotic in gut microbiome composition of healthy adults receiving antibiotic therapy, as measured by changes in alpha and beta diversity of the gut microbiome as compared to placebo.

  Day 0 and Day 14

Secondary Outcomes (7)

• Changes in gut microbiome composition throughout the study as compared to placebo and baseline.

  Day 0, Day 3, Day 7, Day 28, and Day 56

• Changes in abundance of beneficial versus opportunistic/ pathogenic bacterial species throughout the study as compared to baseline and to placebo

  Day 0, Day 3, Day 7, Day 14, Day 28, and Day 56

• Changes in the abundances of microbial genes contained in specific functional modules through the study as compared to baseline and placebo.

  Day 0, Day 7, Day 14, Day 28, and Day 56

• Study the associations of specific microbe abundances with the development of gastrointestinal (GI) symptoms

  Day 0, Day 3, Day 7, and Day 14

• .Changes in the abundances of microbial virulence factors and antibiotic resistant genes through the study as compared to baseline and placebo.

  Day 0, Day 7, Day 14, Day 28, and Day 56

Other Outcomes (2)

• Effects on development of antibiotic-associated diarrhea (AAD) as compared to placebo.

  56 days

• Effects on duration of diarrhea or AAD if presented during the study as compared to placebo.

  56 days

Study Arms (3)

Probiotic

EXPERIMENTAL

Participants in this arm will receive a daily dose of a daily dose of of a probiotic (live bacterium), in a form of 2 capsules once daily, for 28 days.

Dietary Supplement: Probiotic

Postbiotic

EXPERIMENTAL

Participants in this arm will receive a daily dose of a postbiotic (heat-inactivated bacterium), in a form of 2 capsules once daily, for 28 days.

Dietary Supplement: Postbiotic

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive an equivalent placebo for the duration of the study (28 days).

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Participants in this arm will receive a daily dose of of a probiotic (live bacterium), in a form of 2 capsules once daily, for 28 days.

Probiotic

Postbiotic DIETARY_SUPPLEMENT

Participants in this arm will receive a daily dose of a postbiotic (heat-inactivated bacterium), in a form of 2 capsules once daily, for 28 days.

Postbiotic

Placebo DIETARY_SUPPLEMENT

Participants in this arm will receive an equivalent placebo for the duration of the study (28 days).

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• NEXT CRO: collaborator

Study Sites (1)

General Hospital of Thessaloniki Papageorgiou

Thessaloniki, 56429, Greece

Location

MeSH Terms

Conditions

Dysbiosis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

ADM Medical Team

CONTACT

+441460243230; medical@protexin.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)