Evaluation of Butyrate, Zinc and Vitamine D Effect on Microbiota Modulation and Prevention of Antibiotic-associated Diarrhea
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Evaluation of the variation of gut microbiota composition (microbiota test)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects undergoing antibiotic therapy
- •Subjects capable of conforming to the study protocol
- •Subjects who have given their free and informed consent
排除标准
- •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
研究组 & 干预措施
Dibuzin
Group1: 2 capsules/day of DBZ (1 /morning and 1 /evening, away from meals) for 14 gg
干预措施: Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc, (Dietary Supplement)
Placebo
Group2: 2 capsules/day of Placebo (1 /morning and 1 /evening, away from meals) for 14 gg
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Evaluation of the variation of gut microbiota composition (microbiota test)
时间窗: 9 months
Collection of faecal sample for the assessment of the faecal microbiota composition ( rRNA16S) The 16S rRNA gene is a bacterial ribosomal gene and a part of the 30S subunit which is used in the identification, characterization, and classification of various bacteria. Samples were normalized, pooled, and run on Illumina MiSeq , in order to evaluate the composition of gut microbiota in terms of bacterial diversity ( alfa and beta) and abundance and any variability associated with the treatment.
次要结局
- Evaluation of gastrointestinal symptoms ( VAS scale)(9 months)
- Assessment of prevention of Antibiotic-associated diarrhea(9 months)
- Evaluation of psychological state and quality of life ( SF-12)(9 months)