Fermented Dairy Product and Bifidobacterium Diversity

Официальное название

A Randomised, Controlled, Double-blind, Parallel Groups, Single-centre Study to Assess the Bifidobacterium Diversity After 28-days Consumption of a Fermented Dairy Product With Three Bifidobacterium Strains Compared to Yoghurt in 45 to 60-year-old Healthy Subjects

Обзор

Bifidobacterium strains with potential health benefits can contribute to the gastrointestinal wellbeing. However, the ability of these strains to survive gastro-intestinal tract stress and their impact on gut microbiome remains to be clarified. This is why the current study aims to assess the impact of Bifidobacteria consumption on human gut microbiome compared to control product.

Вмешательства

• Другое 28-days consumption of Product A in 45 to 60-year-old healthy subjects
  40 healthy volunteers will consume Product A twice per day during 28 consecutive days
• Другое 28-days consumption of Control product in 45 to 60-year-old healthy subjects
  40 healthy volunteers will consume Control product twice per day during 28 consecutive days

Первичные конечные точки

• The primary outcome parameter in this study is the change from baseline after 28-days product consumption of the number of distinct Bifidobacterium species. [Срок оценки: After 28 days of study product consumption]

Вторичные конечные точки (3)

• The proportion of subjects with presence of viable bacteria of the provided Bifidobacterium strains after 28-days product consumption. [Срок оценки: After 28 days of study product consumption]
• The changes from baseline after 28-days product consumption in quantification of viable bacteria of the provided Bifidobacterium strains. [Срок оценки: After 28 days of study product consumption]
• The change from baseline after 28-days product consumption of Bifidobacterium diversity indices. [Срок оценки: After 28 days of study product consumption]

Критерии участия

Критерии включения

• Male and female subjects aged between 45 and 60 years old.
• BMI between 18.5 kg/m² and 30 kg/m².
• Subjects who are overtly healthy as determined by the investigator.
• Able to speak and read in French.
• Willing and able to collect their faecal samples themselves.
• Having access to adequate space to store the investigational.
• Regular bowel movements.
• Willing to consume the study products twice per day for 28 consecutive days.
• Willing not to consume any fermented dairy products during the entire study, other than the study products.
• Willing not to consume any probiotic, prebiotic or synbiotic supplements during the entire study.
• Willing to limit alcohol consumption during the study.
• Willing not to smoke tobacco during the study.
• Willing not to use any soft or hard drug during the study.
• Signed written informed consent by the participant.
• Female subjects must either be postmenopausal for at least 12 months or have undergone specific surgical procedures resulting in sterility or they are using one of the medically approved contraceptive methods.
• Subject is covered by French health insurance.
• Subject agrees to be registered in the national database of subjects participating in clinical research.
• Subject is willing and able to complete the electronic Patient Reported Outcomes using their own digital device having access to internet.

Критерии исключения

• Any ongoing metabolic disease, hypertension, inflammatory disease, thyroid disease, allergic conditions requiring chronic systemic medication, psychiatric disorder, gastrointestinal disorder, chronic pain, or neurological disorder diagnosed by a physician.
• Known with allergy or intolerance to any ingredients or allergens.
• Pregnancy or breast-feeding at the screening visit or plan for pregnancy during the study.
• Any antecedents of digestive surgery, or plan for such surgery during the study.
• Any dental surgery within the last 4 weeks before the screening visit, or plan for dental surgery during the study.
• Subject who had any surgery or intervention requiring a general anaesthesia in the preceding 4 weeks before the screening visit, or who plans to have one during the study.
• Unable (or unwilling) to adhere to protocol requirements.
• Subject with a special diet at the screening visit, or plan for such diet during the study.
• Major changes in subject's dietary habits ≤ 4 weeks before the screening visit or plan for such major changes during the study including change in vitamin or mineral supplements use, but except for dietary restrictions related to the study.
• Enhanced diet together with intense physical activity ≤ 4 weeks before the screening visit, plan for such a diet and training during the study, or plan for major changes in physical activity during the study.
• Use ≤ 8 weeks before the screening visit or plan of use during the study of systemic medication that can affect the gastrointestinal function or plan of use during the study (if needed, incidental use of ≤ 4 tablets of paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin per 2-week period is allowed.
• Excessive alcohol consumption during the past 6 months before the screening visit.
• Active smoker, or quit active smoking less than 5 years ago before the screening visit. Not regularly smoking is allowed.
• Drug abuse based on investigator's judgement.
• Participation in another study with investigational or marketed products potentially affecting the gut microbiota ≤ 4 weeks before the screening visit or plan for participation in any other intervention study during the study.
• Living in the same home as others already participating in the study and to concomitantly receive some study products.
• Subject under guardianship, curatorship, person under judicial protection, family empowerment or future protection mandate.
• Employees, family members or other relatives of employees of the participating centre or of Danone Global Research \& Innovation Center.
• Subject's total compensation for participation in clinical studies within the past 12 months, including the compensation expected from the Mellifera study, would exceed the annual ceiling of €6,000.

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

Другое

Центры проведения

Франция · 1 центр

• CEN — Dijon

Идентификаторы

NCT: NCT07700381 · 26REX0099946

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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