Evaluation of Butyrate Effect on Diarrhea

Официальное название

Evaluation of Butyrate, Zinc and Vitamine D Effect on Microbiota Modulation and Prevention of Antibiotic-associated Diarrhea

Обзор

The goal of this clinical trial is to evaluate the effects of a Food Supplement containing calcium butyrate, vitamin D, and zinc, on the variation of intestinal microbiota and prevention of antibiotic-induced diarrhea, in individuals who have been prescribed antibiotic therapy. The main questions it aims to answer is: Does Dibuzin improve the microbiota composition in patients undergoing antibiotic treatment? Does Dibuzin prevent antibiotic-induced diarrhea? Participants will: - take 2 capsules/day of DBZ (1 /morning and 1 /evening, away from meals) for 14 gg. -Visit the clinic two times ( T0 and at the end), collect three fecal samples, and fill out two questionnaires 3 times.

Подробное описание

Antibiotic-associated diarrhea (AAD) is an important morbidity resulting from antibiotic use. AAD is more than a bothersome adverse event of antibiotic treatment; it is associated with prescription noncompliance and overuse of second-line antibiotics. Any antibiotic could potentially cause AAD, but broad-spectrum antibiotics that predominantly target anaerobes and are poorly absorbed, have a higher AAD incidence. Alterations in the diversity of the gut microbiota are believed to underlie the development of antibiotic-associated diarrhea, likewise, micronutrient deficiencies can exacerbate both barrier leak and morbidity.

The use of SCFAs, such as butyrate, along with vitamin D and zinc, each possessing unique properties that contribute to enhancing the microbiota, controlling inflammation, and promoting a healthy intestinal barrier, may be beneficial in the prevention of AAD.

The proposed dietary supplement contains butyrate, vitamin D, and zinc, and is presented as a potential product useful in the prevention of AAD.

Вмешательства

• Пищевая добавка Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc,
  In this prospective pilot study, we plan to evaluate the effects of a Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc, on the variation of intestinal microbiota and prevention of antibiotic-induced diarrhea, in individuals who have been prescribed antibiotic therapy.
• Пищевая добавка Placebo
  The intervention with Placebo involves the intake of a product free of bityrate, zinc and vitD

Первичные конечные точки

• Evaluation of the variation of gut microbiota composition (microbiota test) [Срок оценки: 9 months]

Вторичные конечные точки (3)

• Evaluation of gastrointestinal symptoms ( VAS scale) [Срок оценки: 9 months]
• Assessment of prevention of Antibiotic-associated diarrhea [Срок оценки: 9 months]
• Evaluation of psychological state and quality of life ( SF-12) [Срок оценки: 9 months]

Критерии участия

Критерии включения

• Subjects undergoing antibiotic therapy
• Subjects capable of conforming to the study protocol
• Subjects who have given their free and informed consent

Критерии исключения

• Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
• Subjects who become unable to conform to protocol
• Subjects who are continuously taking contact laxatives Subjects who are treated with pre/probiotics

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Edoardo V. Savarino — Padova

Идентификаторы

NCT: NCT06982703 · 5907/AO/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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