NCT02661425已完成不适用
Retrospective Study of Irritable Bowel Syndrome With Diarrhea (IBS-D) Patients Previously Receiving Serum-derived Bovine Serum Immunoglobulin (SBI)
Entera Health, Inc0 个研究点目标入组 165 人开始时间: 2015年12月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 主要终点
- Improvement in the combined score for stool frequency/consistency and abdominal pain intensity during the time that the patient is receiving EnteraGam.
研究概览
简要总结
This is a retrospective study designed to gather outcomes data from existing medical charts from patients who have taken EnteraGam for management of their IBS-D for at least eight weeks. Data from two study periods will be collected: (1) the time during which the Standard of Care (SOC) therapy (i.e., prescribed or over-the-counter as well as FDA-approved or non-approved agents) that is used immediately prior to prescribing EnteraGam; and (2) the time during which EnteraGam is used as therapy.
详细描述
- The first collection of information (Visit 1 - Chart Report Form) will be for the visit at which the SOC therapy, utilized immediately before the introduction of EnteraGam, was initiated. This data point will serve as the baseline for that SOC therapy.
- The second collection of information (Visit 2 - Chart Report Form) will be for the visit at which the original prescription for EnteraGam was written and the patient was instructed to begin the therapy. Captured data will consist of information contained in the patient's chart for a minimum of eight weeks and a maximum of 12 weeks prior to initiation of EnteraGam therapy. This data point will serve as the baseline for initiation of EnteraGam therapy.
- The third collection point (Visit 3 - Chart Report Form) will be at the next patient visit to the clinic - provided that visit is a minimum of eight weeks following initiation of EnteraGam therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Patient is at least 18 years of age at the initiation of EnteraGam therapy.
- •Patient has been previously diagnosed with IBS-D by the physician and has undergone at least one course of SOC treatment prior to receiving EnteraGam.
- •Patient has completed a minimum of eight weeks of EnteraGam therapy for his / her IBS-D.
- •There is recorded information regarding patient response to SOC or EnteraGam for stool frequency/consistency and abdominal pain
排除标准
- •Patient has not taken EnteraGam for a minimum of eight weeks or has not used the product according to the directions provided by the prescribing physician.
- •Patient has not consented to the use of their clinical data in this retrospective clinical investigation.
结局指标
主要结局
Improvement in the combined score for stool frequency/consistency and abdominal pain intensity during the time that the patient is receiving EnteraGam.
时间窗: minimum of 8 weeks
Data collected from existing medical charts
次要结局
- Improvement in stool consistency(minimum of 8 weeks)
- Improvement in fecal incontinence(minimum of 8 weeks)
- Improvement in abdominal pain intensity(minimum of 8 weeks)
- Improvement in fatigue(minimum of 8 weeks)
- Improvement in urgency(minimum of 8 weeks)
- Improvement in stool frequency(minimum of 8 weeks)
- Improvement in bloating(minimum of 8 weeks)
- Improvement in flatulence(minimum of 8 weeks)
研究者
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