FODMAP Reintroduction in Irritable Bowel Syndrome
Клучни зборови
Апстракт
Опис
Research supports clinical experience that ingestion of food often triggers the emergence or exacerbation of symptoms in the majority of patients with irritable bowel syndrome (IBS). While IBS remains primarily a symptom driven entity, our understanding of its pathophysiology is evolving. However, comparatively little research has focused on the specific role of certain foods and how they prompt the development of IBS symptoms.
Food may be linked to changes in motility, visceral sensation, gut microbiome, intestinal permeability, immune activation and brain-gut axis. This study will focus on fructose, which is one of the main components of FODMAP (fermentable oligosaccharides, disacharides, mono-saccharides and polyols) foods. Fructose is a common part of the Western diet and can be consumed as a free monosaccharide, part of sucrose, or in polymers referred to as fructans. There are no human gut specific fructose transporters. Rather glucose transporters are used (GLUT 2,5) leading some to hypothesize that over ingestion of these agents may trigger some of the enteric complaints of patients with IBS. The literature on fructose malabsorption gives varying threshold amounts: from 15 to 50 grams in healthy controls, and from 5 to 50 grams in IBS patients/known malabsorbers (Barrett, 2007; Rao, 2007; Frieling, 2011). Average daily fructose consumption in the American diet is approximately 34 grams, with a range of 15 to 54 grams, which falls well within the threshold levels (Frieling, 2011). FODMAP foods are thought to induce gastrointestinal symptoms including gas, bloating, abdominal pain or discomfort, and loose stools by increasing small bowel water content and increasing gas production by fermentation of foods by gut bacteria. Studies including a recent controlled clinical trial demonstrated that a low FODMAP diet can be an effective nutritional therapy.
There are risks to prolonged use of a low FODMAPs diet. A study from 2012 suggested that continued restriction of FODMAPS (longer than 4 weeks) can lead to reduction of luminal bifidobacteria in patients with IBS. Bifidobacteria mainly inhabit the large intestine where they produce short chain fatty acids (SCFA) as byproducts, including butyrate, shown to be important for colorectal cancer prevention and limit enteropathogenic colonization. Furthermore the diet is very restrictive and difficult for patients to maintain over time.
However, important clinical questions include when FODMAPS can be safely reintroduced into the diet, how quickly this can be accomplished, and what is a daily threshold of intake that is acceptable for IBS patients who respond or do not respond to a low FODMAPs diet. There are no evidence based answers to these questions, and it is in this setting that we propose our current project.
Датуми
| Последен пат проверено: | 04/30/2020 |
| Прво доставено: | 07/24/2017 |
| Поднесено е проценето запишување: | 08/08/2017 |
| Прво објавено: | 08/09/2017 |
| Последното ажурирање е доставено: | 05/27/2020 |
| Последно ажурирање објавено: | 05/31/2020 |
| Крај на датумот на започнување на студијата: | 03/23/2017 |
| Проценет датум на примарно завршување: | 10/23/2020 |
| Проценет датум на завршување на студијата: | 11/23/2020 |
Состојба или болест
Интервенција / третман
Other: Dietary Intervention
Фаза
Групи за раце
| Рака | Интервенција / третман |
|---|---|
| Experimental: 100% Fructose The fructose group will help to determine whether an absolute amount of fructose will lead to IBS symptoms. | |
| Placebo Comparator: 100% Glucose The glucose group will serve as a control since glucose is not a FODMAP and as a result is not expected to lead to recurrent symptoms. | |
| Active Comparator: Fructose and Glucose The glucose/fructose mixture group is a cross comparison group that will determine whether the relative excess fructose concentration is an important cause of IBS symptoms. |
Критериуми за подобност
| Возраст подобни за студии | 18 Years До 18 Years |
| Полови квалификувани за студии | All |
| Прифаќа здрави волонтери | Да |
| Критериуми | Inclusion Criteria: - Adults (18+ years or older) with a diagnosis of IBS-D or IBS-M based on Rome IV criteria - Diarrhea must occur 2 or more days per week - Patients on current pharmacological therapy for their gastrointestinal complaints can enroll in the study as long as they have been on a stable dose for at least 30 days. Exclusion Criteria: - Significant comorbidities that are associated with GI symptoms (e.g. diabetes, scleroderma, SLE), history of GI surgery excluding appendectomy, or prior organic GI illness - Antibiotics taken in the past 2 months - Current disordered eating patterns (diagnosed eating disorder; as per verbal ESP questionnaire) - Current history of greater than moderate alcohol intake (more than 1 drink per day for women, more than 2 drinks per day for men, binge drinking behavior of 5+ drinks in a single session once per week) - Cannot have had a cholecystectomy in the past 6 months prior to enrollment |
Исход
Мерки на примарниот исход
1. Adequate relief of IBS symptoms in past 7 days [Baseline, 4 weeks (post-elimination diet)]
2. Highest amount of grams of sugar in solutions that do not significantly increase IBS symptoms [Daily, during weeks 5-7 (reintroduction phase)]
Секундарни мерки на исходот
1. Change in IBS-symptom severity scale [Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)]
2. Change in Visceral Sensitivity Index (VSI) [Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)]
3. Change in Personal Health Questionnaire (PHQ-15) [Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)]
4. Change in abdominal pain severity [Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)]
5. Change in overall severity of gastrointestinal symptoms [Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)]
6. Change in severity of the sensation of bloating, abdominal fullness or visible distension [Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)]
7. Change in intestinal microbiota [Baseline, 4 weeks (post-elimination diet)]
8. Change in visceral sensitivity index score [Baseline, 4 weeks (post-elimination diet), 7 weeks (post-reintroduction phase)]
