A Prospective, Parallel arm, Randomized, Double-Blind, Comparative Clinical Study to Evaluate the Efficacy and Safety of Bacillus clausii probiotic Formulation in Adult Patients with Acute diarrhea.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in the frequency of defecation (number of stools per day).
研究概览
简要总结
A Prospective, Parallel arm, Randomized, Double-Blind, Comparative Clinical Study to Evaluate the Efficacy and Safety of Bacillus clausii probiotic Formulation in Adult Patients with Acute diarrhea. This study is a Prospective, Parallel arm, Randomized, Double-Blind, comparative clinical trial to assess efficacy, safety and tolerability of Bacillus clausii spores suspension (Strain - AVZ 7911) and Market product in the treatment of participants suffering from acute diarrhoea.Assuming 10% dropout rate, 42 study subjects (21 participants in each arm) will be enrolled in the study and randomized in 1:1 ratio.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant with clinical diagnosis of acute diarrhea.
- •experienced greater than or equal to 3 loose stools within 24 hours for less than 7 days.
- •Male or female adults aged between 18 to 60 years (both inclusive).
- •Patients who have not received antibiotic or probiotic treatment in the last 7 days.
- •Willingness to comply with study protocol/ written informed consent and attend all scheduled visit.
排除标准
- •Patients with chronic or persistent diarrhea more than 7 days.
- •History of inflammatory bowel disease, irritable bowel syndrome, or other gastrointestinal disorders.
- •Patients with severe dehydration requiring intravenous rehydration.
- •Use of antibiotics, antifungals, or other probiotics within the past 7 days.
- •Patient with current use of any other probiotic supplements, antidepressants, antipsychotic or appetite suppressant medicines, or tryptophan (to aid sleep), weight altering medications including homeopathic, ayurvedic, herbal (especially St. John’s wort), Tibetan or Unani preparations, or systemic steroids (chronic use, more than 2 weeks).
- •Patients with bloody or purulent stool, with pus or mucus and severe dehydration needing hospitalization.
- •Subjects with symptoms of septicaemia, faster heart rate and breathing, shortness of breath, sweaty or clammy skin.
- •Participants who have used kaolin, pectin, bismuth subsalicylate, racecadotril, loperamide, atropine and other anticholinergic agents within 48 hours prior to participation in this study.
- •Pregnant or lactating women.
- •Known hypersensitivity or allergy to Bacillus clausii.
- •Refer protocol for all.
结局指标
主要结局
Change in the frequency of defecation (number of stools per day).
时间窗: baseline day 3, day 6, day 8 and day 10
Change in the total duration of diarrhoea (in minutes)
时间窗: baseline day 3, day 6, day 8 and day 10
Change in Stool consistency evaluated on the basis of Bristol stool form scale.
时间窗: baseline day 3, day 6, day 8 and day 10
Change in Abdominal pain score evaluated on a scoring system on the basis of 5-point Likert-Type Symptom Severity Scale
时间窗: baseline day 3, day 6, day 8 and day 10
The use of rescue medication.
时间窗: baseline day 3, day 6, day 8 and day 10
次要结局
- 1.Change in stool examination (stool fat, stool mucus, occult blood, RBC, WBC, ova and parasites in stool).(2.Proportion of participants meeting the recovery criteria, where recovery is)
研究者
Dr Nishesh Jain
Chandra Laxmi Hospital