Safety, Tolerability and Preliminary Efficacy of Oral Administration of Tannins and Flavonoids in the Management of Pediatric Diarrhea
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 主要终点
- Acute (onset <7 days) or Prolonged Diarrhea (onset ≥7 and ≤14 days): Response Rate (RR) measured after 4 treatment days.
研究概览
简要总结
Evaluation of the efficacy of a treatment with Actitan-F, a natural molecular complex of tannins (from Agrimony and Tormentil) and flavonoids (Chamomile) in a pediatric population of children affected by acture/prolonged/chronic diarrhea
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Exclusion Criteria
- •Children of female sex having started menarche;
- •Evidence of severe dehydration, defined as a score > 4 in the Clinical Dehydration Scale;
- •Known hypersensitivity to any of the components (active ingredients or excipients) of the investigational product;
- •Severely malnourished patients, defined as those patients with body weight < 50% for age;
- •History of immune diseases or conditions known to producing immunodeficiency (AIDS, other congenital immunodeficiency syndromes, anticancer drugs, etc.);
- •For acute/prolonged diarrhea only, patients who have received any of the following treatments within the 2 weeks before the screening/baseline visit:
- •Drugs with adsorbing properties, e.g. kaolin, pectin, bismuth subsalicylate;
- •Drugs that modify intestinal secretions, e.g. racecadotril;
- •Drugs that modify intestinal motility, e.g. opiates such as loperamide, atropine and other anti-cholinergic agents);
- •Laxatives
- •Antibiotics
- •History of seizures due to known or unknown causes;
- •Parents/legal guardians' refusal or inability to give written informed consent to participate in the study;
- •Parents/legal guardians who, in the opinion of the Investigator, are unable to fill up the electronic patient diary;
- •Patients who may not be possible to come for the scheduled visits;
- •Patients who have participated in any other clinical trial in the last 3 months prior to the start of the study.
研究组 & 干预措施
Lenodiar Pediatric in Acute/Prolonged Diarrhea
LenoDiar Pediatric acts thanks to Actitan-F, a plant-based molecular complex resulting from Aboca research which reduces attacks of diarrhoea and normalises the consistency of stools, helping to rapidly restore a balanced intestinal function.
Actitan-F counteracts the inflammation of the intestinal mucous membrane, always present in the case of diarrhoea, through two action mechanisms:
- a protective action, achieved by forming a barrier-effect film to limit contact with microorganisms and irritants;
- an antioxidant action on the free radicals which counteracts the irritation of the mucous membrane.
干预措施: Actitan-F (7dd) (Device)
Lenodiar Pediatric in Chronic Diarrhea
LenoDiar Pediatric acts thanks to Actitan-F, a plant-based molecular complex resulting from Aboca research which reduces attacks of diarrhoea and normalises the consistency of stools, helping to rapidly restore a balanced intestinal function.
Actitan-F counteracts the inflammation of the intestinal mucous membrane, always present in the case of diarrhoea, through two action mechanisms:
- a protective action, achieved by forming a barrier-effect film to limit contact with microorganisms and irritants;
- an antioxidant action on the free radicals which counteracts the irritation of the mucous membrane.
干预措施: Actitan-F (28dd) (Device)
结局指标
主要结局
Acute (onset <7 days) or Prolonged Diarrhea (onset ≥7 and ≤14 days): Response Rate (RR) measured after 4 treatment days.
时间窗: Day0 to Day4
Acute (onset \<7 days) or Prolonged Diarrhea (onset ≥7 and \<14 days): Response Rate (RR) measured after 4 treatment days. Patients will be considered as responders if they have experienced the passage of 2 formed stools or no stool for at least 12 consecutive hours during the 4 days treatment.
Chronic Diarrhea (onset >14 days): Response Rate (RR) measured across the whole treatment period
时间窗: Day0 to Day28
Chronic Diarrhea (onset \>14 days): Response Rate (RR) measured across the whole treatment period (4 weeks). Patients will be considered as responders if they have experienced a 50% (or more) reduction in the number of days with at least 1 diarrheic stools (Bristol score 6 or 7) in the whole treatment period (4 weeks) compared to the 7 days prior the treatment (baseline).
次要结局
- Number of unformed stools passed per 24-h interval, after the first dose(Day0-Day28)
- Number of episodes of daily watery evacuations(Day0-Day28)
- Number of treatment failures(Day0-Day28)
- Difference in body weight(Day0-Day28)
- Frequency and severity of diarrhea associated symptoms(Day0-Day28)
- Treatment Compliance(Day0-Day28)
- Proportion of patients requiring other (allowed) treatments(Day0-Day28)
- Change in results in parent assessment of children Quality of Life (100 mm VAS)(Day0-Day28)
- Change in results of the Pediatric Quality of Life Questionnaire (PedsQL)(Day0-Day28)
- Safety and tolerability of the treatment: Incidence of adverse events (AEs) and serious adverse events (SAEs), and rate of study discontinuations due to AEs/SAE;(Day0-Day28)