Low FODMAP Diet on Nutritional Status, Disease Activity and Gut Microbiota in IBS and UC With Normal or Overweight BMI
Keywords
Abstract
Description
Irritable Bowel Syndrome (IBS) and Ulcerative Colitis (UC) affect principally the gut, causing symptoms that alter intestinal motility, with a multifactorial etiology. The pharmacological and nutritional treatment varies according to the symptoms and activity of each patient. The most commonly used are the standard diet (SD), which excludes foods known as irritants or inflammatory. On the other hand, are the low fodmap diet (LFD) (fermentable oligosaccharides. disaccharides, monosaccharides and polyols), these highly fermentable carbohydrates can pass unabsorbed to the colon and induce the gas production due to the fermentation of gut microbiota and cause symptoms such as: bloating, flatulence, abdominal pain and altered bowel habit. It consists in two stages: first the restriction of all foods that contain fodmaps and second the re exposure in which indicate the introduction of each food restricted before to evaluate the tolerance, for 6 to 8 weeks. Some studies show that the low fodmap diet improve the symptoms in both groups, however because of the restriction and the limited content of foods, they have had risk to present nutritional deficiencies. The aim of the present is to evaluate the effect of a low fodmap diet for 10 weeks on gastrointestinal symptoms, nutritional status and microbiota in patients with IBS and UC.
Methods: a controlled, blinded clinical trial will be conducted in patients who assist to medical monitoring in gastroenterology service with diagnosis of IBS or UC. The sample size was determined with a 0.5 effect size, an alpha error 0.05 and power of 80%, which determined 64 patients for each group (total: 128). After singing the informed consent, will be determined their total energy expenditure (TEE) and consecutively will be assigned an ID previously randomized to SD (<16 g of fodmaps) or LFD (<10 g of fodmaps), with a distribution of 55% carbohydrates, 20% proteins and 25% lipids. During the 10 weeks will be three follow-ups, first the basal, intermediate (week 5) and final (10 weeks after), will be performed body composition (RJL Quantum III), anthropometry (waist, hip, arm and chest circumference), gastrointestinal symptoms (ROMA III and Mayo Scale), quality of life (WHOQL-BREF), food frequency and 24-hour reminder and blood chemistry (anemia, hypoalbuminemia, vitamin D, calcium, potassium, c reactive protein, VSG, etc), all of them basal and final.
Dates
| Last Verified: | 02/28/2019 |
| First Submitted: | 10/07/2019 |
| Estimated Enrollment Submitted: | 10/27/2019 |
| First Posted: | 10/28/2019 |
| Last Update Submitted: | 10/27/2019 |
| Last Update Posted: | 10/28/2019 |
| Actual Study Start Date: | 02/09/2018 |
| Estimated Primary Completion Date: | 08/30/2020 |
| Estimated Study Completion Date: | 08/30/2020 |
Condition or disease
Intervention/treatment
Other: Low FODMAP diet
Other: Standard diet
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: FODMAP diet in Irritable Bowel Syndrome Patients with IBS will be randomized to standard diet or low fodmap diet. The nutritional status (body composition and clinical parameters), gut microbiota, adherence to treatment, improvement of gastrointestinal symptoms and quality of life will be evaluated for 10 weeks. | |
| Experimental: FODMAP diet in Ulcerative Colitis Patients with UC will be randomized to standard diet or low fodmap diet. The nutritional status (body composition and clinical parameters), gut microbiota, adherence to treatment, improvement of gastrointestinal symptoms and quality of life will be evaluated for 10 weeks. | |
| Active Comparator: FODMAP diet in healthy patients Healthy patients will be randomized to standard diet or low fodmap diet. The nutritional status (body composition and clinical parameters), gut microbiota, adherence to treatment, improvement of gastrointestinal symptoms and quality of life will be evaluated for 10 weeks. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Irritable Bowel Syndrome confirmed by Rome criteria III - Ulcerative Colitis confirmed by Mayo Scale - Informed Consent signed - BMI between 18.5 and 29.9 kg/m2 - Males and females - Age between 18-59 years - Mexican patients Exclusion Criteria: - Chron´s disease diagnosed - Treatment whith antibiotis during the last two weeks - Bowel resection - Short bowel syndrome - Treatment wihth probiotics or enzimes (A-galactosidase) - Pregnancy - Nutritional deficiencies or anemia - Patients whith diet supplements |
Outcome
Primary Outcome Measures
1. Nutritional status [The patients will be evaluated at weeks 1 and 10]
Secondary Outcome Measures
1. Quality of life in patients with Irritable Bowel Syndrome and Inflammatory Bowel Disease [The patients will be evaluated at weeks 1, 5 and 10]
2. Adherence to treatment [The patients will be evaluated at weeks 1, 5 and 10]
3. Body composition analysis [The patients will be evaluated at weeks 1, 5 and 10]
4. Gut microbiota with a low FODMAP diet [Participants will be evaluated at weeks 1, 5 and 10]
5. Blood chemistry [Participants will be evaluated at weeks 1 and 10]
6. Irritable Bowel Syndrome Severity Score [Participants will be evaluated at weeks 1, 5 and 10]
7. Gastrointestinal Symptoms Severity [Participants will be evaluated at weeks 1, 5 and 10]
8. Anthropometric measurements [Participants will be evaluated at weeks 1, 5 and 10]
