Fecal Bile Acids, Fecal Short Chain Fatty Acids and the Intestinal Microbiota in Patients With Irritable Bowel Syndrome (IBS) and Control Volunteers: Diet Challenge
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Total Fecal Bile Acids
研究概览
简要总结
The purpose of this study is to study the relationship between the bile acids, short chain fatty acids and bacteria within the intestines. The hypothesis is that changes in the bacterial composition of the stool are associated with the differences in bile acids and short chain fatty acids in patients having irritable bowel syndrome compared to healthy individuals.
详细描述
The Study involves 3 visits and will in include 3 types of subjects - those who have irritable bowel syndrome (IBS) with constipation (IBS-C), IBS with diarrhea (IBS-D) and those who have no IBS symptoms or diagnosis.
Visit 1
- Volunteers will read and sign this informed consent after all questions about the study have been answered
- This is a screening visit and we may determine that volunteers ineligible to continue to participate in the study.
- Volunteers will have a medical history taken including demographics, history of symptoms and illness
- Volunteers will be asked about all medications
- A physical exam will be performed by the physician.
- Vital signs will be measured.
- Urine Pregnancy test may be done for woman in the reproductive age range.
- Eligible participants will be provided with a take-home lasagna meal.
- Participants will be given instructions and supplies for collection, storage and transportation of stool for the next visit.
- Participants will be provided with instructions for a low fiber, high fat diet which should be consumed for 2 days before stool collection and during the 2 days of stool collection. Instructions will also come with materials to allow participants to record diet intake during these 4 days.
- Participants will be provided a bowel pattern diary to record bowel symptoms over the course of the study
Day 1: this may be the same as Visit 1 or it may be a different day. It will depend upon the day that participants can make it back to the clinic for the Day 5 visit.
Day 2-4 (at home):
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls with no prior history of GI disease or symptoms.
- •Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low FODMAP diet at the time of study participation.
排除标准
- •Participants with microscopic/lymphocytic/collagenous colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated AST/ALT > 2.0x the upper limit of normal
- •Prior radiation therapy of the abdomen or abdominal surgeries except for C-section, tubal ligation, vaginal hysterectomy and appendectomy or cholecystectomy, > 6 months prior to study initiation.
- •Ingestion of any prescription, over the counter, or herbal medications which can affect GI transit or study interpretation (e.g. opioids, narcotics, anticholinergics, norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors, bile acid sequestrants) within 6 months of study initiation for asymptomatic volunteers or within 2 days before study initiation for IBS patients. Rescue therapy to facilitate stool collection will be permitted where needed.
- •Any females who are pregnant or trying to become pregnant or breast-feeding
- •Antibiotic usage within 3 months prior to study participation
- •Prebiotic or probiotic usage within the 2 weeks prior to study initiation
- •Regular use of tobacco products within the past 6 months.
结局指标
主要结局
Total Fecal Bile Acids
时间窗: 48 hours
Stool samples will be collected over 2 days for measurement of fecal bile acids (mcmol/48h) by high performance liquid chromatography-mass spectometry
Total Fecal Short Chain Fatty Acids
时间窗: 48 hours
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Individual Fecal Short Chain Fatty Acids - Acetate
时间窗: 48 hours
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Individual Fecal Short Chain Fatty Acids - Propionate
时间窗: 48 hours
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Individual Fecal Short Chain Fatty Acids - Butyrate
时间窗: 48 hours
Stool samples will be collected for measurement of measurement of short chain fatty acids (mmol/kg) by liquid chromatography-mass spectrometry
Fecal Microbial Population
时间窗: 48 hours
Stool samples will be be collected from participants for nucleic acid extraction, shotgun sequencing is used to measure microbial communities and profiles of specimens. Shannon index is calculated to measure the diversity of species. The minimum value is 0. There is no upper limit. The higher the Shannon index is, the greater the diversity of species is.
Fecal Inulin
时间窗: 48 hours
Fecal inulin content will be measured using short acid hydrolysis and high-performance liquid chromatography
次要结局
- Percent Primary Fecal Bile Acids(48 hours)
- Stool Characteristics - Stool Frequency in 4 Days(4 days)
- Stool Characteristics - Stool Form(4 days)
- Stool Characteristics - Ease of Passage(4 days)
研究者
Huiping Xu
Associate Professor
Indiana University