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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка Probiotic
  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.
• Пищевая добавка Postbiotic
  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.
• Пищевая добавка Placebo
  Participants in this arm will receive an equivalent placebo for the duration of the study (28 days).

Первичные конечные точки

• Changes in gut microbiome composition between baseline and day 14 as compared to placebo. [Срок оценки: Day 0 and Day 14]

Вторичные конечные точки (7)

• Changes in gut microbiome composition throughout the study as compared to placebo and baseline. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: Day 0, Day 7, Day 14, Day 28, and Day 56]
• Safety profile throughout the study as compared to placebo. [Срок оценки: 56 days]
• Tolerability of a probiotic or postbiotic as measured by a validated questionnaire and compared to placebo. [Срок оценки: Day 0, Day 7, Day 14, Day 28, and Day 56]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Греция · 1 центр

• General Hospital of Thessaloniki Papageorgiou — Thessaloniki

Идентификаторы

NCT: NCT07594860 · CTB2024TN403

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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