NCT04155801已完成不适用
An Open-Label, Multicenter Study to Assess the Efficacy and Safety of Salix Probiotic Blend in Subjects With Functional Gastrointestinal Disturbances
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Percentage of Participants with a Positive Response to the Product Satisfaction Question
研究概览
简要总结
The primary objective of this study is to assess the safety and efficacy of Salix Probiotic Blend, administered orally for 30 days, in participants with functional gastrointestinal (GI) disturbances.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have symptoms of GI disturbances.
- •Participant has recurrent abdominal pain, discomfort, bloating, and/or abdominal distention associated with a change in the frequency of stool and/or a change in the form (appearance) of stool.
- •Participant is able to understand the nature and purpose of the study and provide informed consent.
- •Sexually active males and sexually active females of child-bearing potential, defined as neither surgically sterile nor post-menopausal (that is, females age >45 years and no menstrual periods for at least 1 year), must agree to use a highly effective method of contraception from Screening to 30 days post last dose of study product. Acceptable forms of contraception include the following:
- •Abstinence
- •Oral, injected, or implanted hormonal methods of contraception
- •Intrauterine device or intrauterine contraceptive system
- •Condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •Female whose last sexual intercourse with males was ≥6 months post-vasectomy
排除标准
- •Participant has active or a history of inflammatory bowel disease.
- •Participant has other significant systemic diseases such as active cancer therapy, active/ongoing infection, uncontrolled diabetes, chronic renal failure, cirrhosis, congestive heart failure, and severe Chronic Obstructive Pulmonary Disease (COPD).
- •Participant has used antipsychotic medications within 3 months prior to Screening.
- •Participant has used systemic steroids within the month prior to Screening.
- •Participant has suffered from a major psychiatric disorder within the past 2 years.
- •Participant is pregnant or breastfeeding.
- •Participant has a known lactose intolerance.
- •Participant is immunocompromised or has an immunodeficiency syndrome of any kind.
- •Participant has undergone any abdominal surgery, except for hernia repair or appendectomy.
- •Participant has had active treatment with prescription medication for irritable bowel syndrome (IBS) within 6 weeks prior to Screening.
- •Participant has been diagnosed with infectious gastroenteritis within 1 month prior to Screening.
- •Participant has undergone treatment with probiotics within 6 weeks prior to Screening.
- •Participant is on active treatment with antibiotics.
- •Participant has a known fructose intolerance.
- •Participant is currently on a low fermentable oligo-, di-, mono-saccharides and polyols (FODMAP) diet.
- •Participant has a known diagnosis of gastroparesis.
结局指标
主要结局
Percentage of Participants with a Positive Response to the Product Satisfaction Question
时间窗: Day 42 (End of Study [EOS] Visit)
Participants will be asked to consider how they felt in the past week in regard to their gastrointestinal well-being and symptoms of abdominal discomfort or pain, bloating, or distension, gas, and altered bowel habit, and to respond to the following overall product satisfaction question: "Compared to the way you felt before beginning the supplement, how strongly do you feel you have had improvement of your overall gastrointestinal well-being?". Responses will be assessed on a Likert 6-point scale. Potential responses will include 1=strongly agree, 2=disagree, 3=slightly disagree, 4=slightly agree, 5=agree, and 6=strongly agree. The percentage of participants with the response of 4=slightly agree, 5=agree, and 6=strongly agree will be reported.
次要结局
- Change From Baseline in Intestinal Fatty-Acid Binding Protein (I-FABP) Levels (Intestinal Integrity Serum Marker) at Day 30(Day 30)
- Overall Product Satisfaction Evaluation(Day 30)
- Measures of Quality of Life Using the Irritable Bowel Syndrome Quality of Life (IBS-QOL) Questionnaire(Baseline up to Day 42 (EOS Visit))
- Severity of Diarrhea, Constipation, Straining, Urgency, Abdominal Pain/Discomfort, Bloating, and Distention as Measured by the Gastrointestinal (GI) Health Symptom Questionnaire(Baseline up to Day 42 (EOS Visit))
- Frequency of GI Symptoms as Measured by the GI Health Symptom Questionnaire(Baseline up to Day 42 (EOS Visit))
- Satisfaction with Ability to Fully Empty Bowels as Measured by the GI Health Symptom Questionnaire(Baseline up to Day 42 (EOS Visit))
- Satisfaction with Bowel Habits as Measured by the GI Health Symptom Questionnaire(Baseline up to Day 42 (EOS Visit))
- Passage of Gas Symptoms as Measured by the GI Health Symptom Questionnaire(Baseline up to Day 42 (EOS Visit))
研究者
研究点 (2)
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