ACTRN12615000596505已完成未知
Assessment of the effect of intestinal permeability probes (lactulose and mannitol) and other liquids on digesta residence times in various segments of the gut determined by wireless motility capsule in healthy female subjects.
The New Zealand Institute for Plant & Food Research Limited.0 个研究点目标入组 6 人开始时间: 2015年6月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Diagnosis
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 20 Years 至 40 Years（—）
- 性别
- Female
入选标准
- •Healthy female volunteers of 165-170cm; 65-70kg between the age of 20 and 40 years will be screened by questionnaire for general medical health, gut health, ongoing consumption of medication, dietary supplements, dietary peculiarities and smoking. Inclusion criteria is as follows: (1) Participants will be non smokers with no history of gastrointestinal diseases including recent gut infection evidenced by a recent history of abdominal pain, nausea, vomiting, diarrhea, passage of blood and mucus in stools. (2) Participants will be taking no ongoing prescription or OTC medication or multivitamins except for contraceptive pills. (3) Not taking any medications that affect gastrointestinal motility such as pro-kinetics, narcotic analgesics, antispasmodics, or pills to treat diarrhea and constipation. (4) The number of standard alcohol drinks consumed per week will be calculated from results of alcohol consumption in the questionnaire to ensure that participants do not exceed a moderate alcohol intake.
排除标准
- •Participants will be screened by a Health Questionnaire to determine participation in the study. Volunteers who will be excluded are those that: (1) Are of small stature (no less than 165-170cm; apprx 65-70 kg), (2) Are smokers or tobacco chewers, (3) Exceed the intake of one standard alcohol drink per day, (4) Have a history of gastrointestinal diseases including recent gut infection evidenced by a recent history of abdominal pain, nausea, vomiting, diarrhea, passage of blood and mucus in stools, (5) Suffer from any inter current gastrointestinal disorder (contraindicated dysphagia, gastric bezoars, strictures, fistulas, bowel obstructions, diverticulitis, previous gastrointestinal surgery) and are likely to retain the capsule in the stomach (as has rarely been reported), (6) Have implanted electromechanical medical devices and medications that influence gastrointestinal transit time, (7) Have an earlier diagnosis of diabetes, cancer, Crohn’s disease, ulcerative colitis, irritable bowel disease, (8) Have undergone abdominal surgery, (9) Have a BMI < 18.5 or > 30kg/m2, (10) Are pregnant or lactating, (11) Have irregular menstrual cycles, (12) Have a high dietary fibre intake or on a vegetarian diet, (13) Have food allergies, (14) Have a history of or current urinary tract infections, vaginal conditions that cause discharge, (15) Have aspirin sensitivity, (16) Take ongoing prescription medication, antibiotics, OTC medication or multivitamins, (17) Take prebiotic and probiotic and fibre supplements such as lactulose.
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