Efficacy and Tolerability of a Nutritional Supplementation With Medical Nutrition Formulations Enriched With Postbiotics for the Management of Gastrointestinal Disorders: a Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Faecal calprotectin
研究概览
简要总结
Efficacy and tolerability of ABB i5 prebiotic and ABB C22 postbiotics for the management of constipation and gastrointestinal well-being: a pilot trial
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients of the centre
- •Diagnostic of diarrhoea: increase in daily faecal weight > 200 g (as per the Centre protocol).
- •Subjects who as per the Centre protocol require Oral rehydration therapy
- •Patients with the ability to take the study product orally
排除标准
- •History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active principle or to any of the excipients.
- •History or evidence of any medical conditions or medication used that, in the opinion of the principal investigator, could affect the safety of the subjects or interfere with the study evaluations
- •Patients in situation of last days
- •Amytriptilin and masalazine treatment (anti-depressives)
- •Laxatives
结局指标
主要结局
Faecal calprotectin
时间窗: from baseline to day 14 of supplementation
change in faecal calprotectin levels (mg/g)
faecal lactoferrin
时间窗: from baseline to day 14 of supplementation
change in the number of participants with a positive "faecal lactoferrin" result (%)
Blood IgAs
时间窗: from baseline to day 14 of supplementation
levels of serum IgAs (mg/dL)
Faecal calprotectin
时间窗: from baseline to day 14 of supplementation
change in faecal calprotectin levels (mg/g)
faecal lactoferrin
时间窗: from baseline to day 14 of supplementation
change in the number of participants with a positive "faecal lactoferrin" result (%)
Blood IgAs
时间窗: from baseline to day 14 of supplementation
levels of serum IgAs (mg/dL)
次要结局
- Gastrointestinal symptoms(from baseline to day 14 of supplementation)
- faecal consisitency(from baseline to day 14 of supplementation)