Defining Objective Markers of Compliance for Dietary Therapies in Irritable Bowel Syndrome (IBS) Using a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
研究概览
简要总结
This research will investigate if a specific marker in your stool or urine can be used to track changes in your carbohydrate intake including fructo-oligosaccharide and mannitol intake
详细描述
The primary purpose of this study is to evaluate if an objective biomarker can be used to evaluate the amount of specific carbohydrate intake. It is to measure the coloration between Gluten immunogenic Peptides (GIP) and fructo-oligosaccharide intake(on 24-hour diet recall) at Week 4 to identify an objective biomarker for dietary content evaluation which is critical for dietary treatment.
The researchers hope GIP can be used to evaluate the amount of carbohydrate intake in clinical practice.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants will know that both diets (FODMAP-simple and BDA/NICE) are predicted to help improve their IBS symptoms, but will not know that we are specifically investigating the role of FODMAPs. Instead, participants will be informed they are receiving either Diet A, Diet B differing in the types and amounts of specific foods provided. Furthermore, study coordinators will be blinded to which diet the participant receives. Also, Site PIs and co-Is will also be blinded to the randomization.
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
- 否
入选标准
- •Patients with IBS ( including diarrhea, mixed or constipation type) and without unexplained alarm features (rectal bleeding, weight loss, nocturnal pain, nocturnal diarrhea). In presence of alarm symptoms, if they have had evaluation with colonoscopy or fecal calprotectin or serum C-reactive protein (CRP) since onset of alarm symptoms with normal results, they will be included.
- •Aged 18-65 years at the time of screening
- •IBS-SSS of at least 175 at baseline
排除标准
- •Subjects adhering to a dietary treatment such as the low-fat diet, low FODMAP diet, or gluten-free diet, within the past 6 months. Those who are lactose intolerant will not be excluded from the study and will be allowed to limit lactose intake as previously.
- •Subjects who are predicted to make changes to their baseline IBS medication(s), over-the-counter (OTC) therapy, exercise, diet (beyond what is advised), or initiate/make changes to other complementary therapy that could affect IBS symptoms (e.g. yoga, acupuncture, etc.) during the four weeks study period.
- •Subjects with a known history of celiac disease, inflammatory bowel disease or microscopic colitis
- •Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
- •BMI < 18.5
- •Subjects with prior small bowel or colonic surgery (other than appendectomy or cholecystectomy).
- •History of appendectomy or cholecystectomy in the last 6 months.
- •Oral antibiotic use in the past 3 months
- •Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study.
- •Currently pregnant or breastfeeding.
研究者
Prashant Singh
Assistant Professor of Internal Medicine
University of Michigan