CTRI/2025/09/094597尚未招募不适用
A Randomized, Double-Blind, Controlled Clinical Trial To Evaluate The Safety And Efficacy Of Nutraceutical Formulations Containing Postbiotic Trybutyrin, Probiotics, And A Pre/Pro/Postbiotic Combination In Adults With Functional Gastrointestinal Disorders.
Aeon Formulations Pvt Ltd1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To compare the efficacy of Postbiotic Trybutyrin, probiotics, and Pre/Pro/Postbiotic
研究概览
简要总结
Introduction Postbiotics represent the next generation of gut microbiota-targeted therapies beyond probiotics and prebiotics. Trybutyrin (tributyrin) delivers bioavailable butyrate, a short-chain fatty acid essential for gut integrity, metabolic balance, and immune modulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 to 65 years.
- •Subjects with Rome IV criteria-based diagnosis of IBS, OR Individuals with functional gastrointestinal symptoms (e.g., bloating, mild abdominal pain, altered bowel habits) but no serious underlying disease.
- •Stable clinical condition without acute illnesses.
- •Willing and able to provide written informed consent.
- •Capable of understanding and adhering to the protocol, including completion of the symptom diaries and follow-up visits.
排除标准
- •Recent use of related interventions: Use of antibiotics, probiotics, prebiotics, or postbiotics within 4 weeks prior to screening.
- •Gastrointestinal comorbidities: History or presence of inflammatory bowel disease, celiac disease, gastrointestinal malignancies, GI surgeries (except appendectomy or hernia repair), or severe dysbiosis.
- •Chronic conditions: Poorly controlled diabetes, renal, hepatic, or cardiovascular diseases.
- •Immunocompromised status: Including HIV, cancer chemotherapy, or immunosuppressive therapy.
- •Pregnancy and lactation.
- •Known allergy or hypersensitivity to any component of the investigational products.
- •Participation in another clinical trial within the past 30 days.
- •Psychiatric or cognitive disorders that may affect compliance or accurate symptom reporting.
结局指标
主要结局
To compare the efficacy of Postbiotic Trybutyrin, probiotics, and Pre/Pro/Postbiotic
时间窗: Day 1, 15, 30, 45, and 59
FDC.
时间窗: Day 1, 15, 30, 45, and 59
次要结局
- To assess the safety and tolerability of all interventions.(To explore mechanisms of action)
研究者
Dr Jothi Shankar
Srinivasan Rajalakshmi Memorial Hospital (SRMH)
研究点 (1)
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