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临床试验/NCT03052439
NCT03052439已完成不适用

Charting a Course to a Less Restrictive Diet for IBS

University of Michigan2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Abdominal Pain

研究概览

简要总结

Irritable bowel syndrome (IBS) is the most common gastrointestinal disease, affecting 12% of the US population and up to 20% of the population worldwide. This is a condition that is diagnosed based on specific symptoms of altered bowel habits and abdominal pain, as well as the exclusion of select other GI diseases. IBS not only causes constipation, diarrhea, abdominal cramping, and bloating, it also significantly affects quality of life, overall functioning, and work productivity.

The cause of IBS is likely multifactorial, which makes it a difficult disease to treat. However, patients often associate their IBS symptoms with eating a meal. Up to 90% of IBS patients restrict their diet to prevent or improve their symptoms, and patients are increasingly interested in more holistic approaches to disease management. At present, the most persuasive evidence that dietary changes can treat IBS supports a diet low in fermentable carbohydrates (the low FODMAP (fermentable oligo, di, and monosaccharides and polyols) diet). This diet, which is low in certain carbohydrates, has been shown to improve IBS symptoms (particularly abdominal pain and bloating), but can be difficult to follow and quite restrictive. In addition, this diet is not meant to be used as a maintenance diet; patients undergo an elimination phase followed by a reintroduction phase of specific carbohydrate groups as they monitor their symptoms. From the results of our proposed study, the study team hopes to arrive at a modified, less -restrictive version of the low FODMAP diet that is equally effective, and also create a standard protocol that patients can use during this reintroduction phase.

Patients with IBS will be recruited into a 13-week trial that would help determine the optimal way in which high FODMAP foods should be introduced. After consent, patients would start on a low FODMAP diet for 14 days, and if their symptoms improve, they would be invited to continue in the study. For 7 days prior to the reintroduction of individual FODMAPs, patients will ingest 1daily servings of a low FODMAP nutrition drink to validate the low FODMAP content of this dietary supplement. If patients do not experience a flare of symptoms with the supplement, they enter the reintroduction period. During this period, subjects would introduce different groups of FODMAPs in a blinded fashion while remaining on an otherwise low FODMAP diet while monitoring their IBS symptoms. At the end of the study period, subjects would be informed of the FODMAPs to which they were sensitive and would meet with a dietitian. At the completion of the study, the investigators would compile the data and determine which FODMAPs were mostly likely to exacerbate IBS symptoms, thus providing the construct for a modified low FODMAP diet, or "low FODMAP-Light." It is hoped that this modified, less restrictive version of the low FODMAP diet would be equally effective for the majority of IBS patients.

详细描述

Research Plan Design: Blinded FODMAP reintroduction study Duration of study: 1 year

Patient population:

Eligible IBS patients

Visit 1 (-2 weeks): After providing written informed consent, baseline and descriptive data will be obtained including age, sex, race, pertinent medical history, prior IBS treatments, vital signs, weight, use of concurrent medications and supplements, duration of symptoms, and baseline symptoms. The investigators will also collect blood, stool and urine for a series of separately funded translational studies assessing immune activation, permeability, and microbiome.

After this visit, patients will enter a two-week screening period during which severity of symptoms will be assessed. Eligible patients will rate their average daily abdominal pain/discomfort as a 4 or higher on an 11 point numerical rating scale (NRS) (0-no pain, 10-intolerable pain) and IBS subtype of constipation-predominant, diarrhea- predominant, or mixed bowel habits (by Rome IV criteria19). Patients with an indeterminate subtype will be excluded. Patients will record symptoms (Table 1) daily using a web-based survey instrument. Experience from previous diet trials suggests that approximately 50% of participants will not fulfill these inclusion criteria after the screening period, and will be termed screen failures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants blinded to randomization of order of reintroduction; Investigators blinded to order of reintroduction

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females, at least 18 years of age, able to provide informed consent
  • Meet Rome IV criteria for IBS-C (constipation-predominant), IBS-D (diarrhea-predominant), IBS-M (mixed bowel habits) as assessed by a gastroenterologist
  • Willingness to maintain a stable dosage of IBS medications during the pretreatment baseline period, including tricyclic antidepressants; "rescue" medications permitted (ie loperamide)
  • For IBS-D patients only, documentation of normal colonoscopy or flexible sigmoidoscopy with colon biopsies within five years
  • Documentation of normal TSH, CBC, CRP, electrolyte panel
  • Negative evaluation for celiac disease either with normal TTG IgA, EMA, and/or duodenal biopsy.

排除标准

  • Pregnancy
  • IBS-U subtype (undetermined)
  • Comorbid medical problems that may affect gastrointestinal transit or motility (inflammatory bowel disease, extra-intestinal disease known to affect the gastrointestinal system (scleroderma, unstable thyroid disease, uncontrolled diabetes mellitus, etc.), severe renal or hepatic disease
  • Previous treatment with a low FODMAP diet or active participation in another form of dietary therapy
  • Previous surgery to the GI tract except appendectomy or cholecystectomy if performed more than six months prior to enrollment.
  • Medications not permitted include probiotics, antibiotics, laxatives, and narcotics

结局指标

主要结局

Abdominal Pain

时间窗: 1 week

Daily score (0-10) for abdominal pain will be recorded. This will be averaged and compared to the baseline and run-in periods

次要结局

  • Stool Consistency(1 week)
  • Sleep quality(1 week)
  • Stool urgency(1 week)
  • Fatigue(1 week)
  • Bloating(1 week)
  • Stool Frequency(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shanti Eswaran

Clinical Assistant Professor

University of Michigan

研究点 (2)

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