Low FODMAP Diet on Nutritional Status, Disease Activity and Gut Microbiota in IBS and UC With Normal or Overweight BMI

IBS - Irritable Bowel Syndrome Clinical Trial

Official title:

Low FODMAP Diet Chronic Effect on Nutritional Status, Disease Activity and Gut Microbiota in Patients With IBS and UC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04143633
• Other study ID #: DI/17/301/03/084
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: March 2019
• Source: Hospital General de Mexico
• Contact: Nallely Bueno Hernández, PhD
• Phone: 27892000
• Email: nallely_bh5[@]yahoo.com.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Gastrointestinal disorders represents 20-50% of referrals to the gastroenterologist; being the most affected womens, youths and older adults. Among these alterations are the Irritable Bowel Syndrome (IBS) and Ulcerative Colitis (UC), which affects the gut causing impaired motility. The pharmacological and nutritional treatment are modified according to the symptomatology and activity of each patients. Currently the implementation of low FODMAP diets for 6 to 8 weeks in patients whith IBS improves symptoms such as bloating, flatulence and abdominal pain. However due to the number of restricted foods a long term attachment could limited the nutritional content, consequently affecting the nutritional status, gut microbiota an quality of life. A low FODMAP diet are useful to improve gastrointestinal symptoms in patients with UC and causes changes in nutritional status.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• IBD - Inflammatory Bowel Disease
• IBS - Irritable Bowel Syndrome
• Inflammatory Bowel Diseases
• Irritable Bowel Syndrome
• UC - Ulcerative Colitis
• Ulcer

Intervention

Other:
• Low FODMAP diet
The diet will be in accordance to the baseline energy expenditure calculated by Harris-Benedict whit 55% of carbohydrates, 25% of lipids and 20% of proteins, divided in five meals. The distribution of carbohydrates depends on the content of fodmaps on each food.
• Standard diet
The diet will be in accordance to the baseline energy expenditure calculated by Harris-Benedict whit 55% of carbohydrates, 25% of lipids and 20% of proteins, divided in five meals. Cruciferous vegetables, fruits and condiments will be eliminated and a normal content of fodmap.

Locations

Country	Name	City	State
Mexico	Nallely Bueno Hernández	Mexico City	Cuauhtémoc

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nutritional status	Changes from baseline of nutrtitional status measured with cholesterol (mg/dl), triglycerides (mg/dl), albumin (mg/dl), calcium (mg/dl), iron (mg/dl), vitamin B12 (mg/dl), vitamin D (mg/dl), hemoglobin (mg/dl), hematocrit (mg/dl), creatinin (mg/dl) on blood	The patients will be evaluated at weeks 1 and 10
Secondary	Quality of life in patients with Irritable Bowel Syndrome and Inflammatory Bowel Disease	Changes from baseline of WHOQOL- BREF (World Health Organization Quality of Life) questionary score (the higher score, the higher quality of life represents) measured with a Likert scale at 10 weeks of nutritional intervention in patients wiht irritable bowel syndrome and inflammatory bowel disease	The patients will be evaluated at weeks 1, 5 and 10
Secondary	Adherence to treatment	By 24 hour recalls during the ten weeks of the study and food frequencies at week one, five and ten.	The patients will be evaluated at weeks 1, 5 and 10
Secondary	Body composition analysis	Changes from baseline of the percentage of body fat (%), muscle (%) and water (%) at 10 weeks of nutritional intervention, using RJL System IV	The patients will be evaluated at weeks 1, 5 and 10
Secondary	Gut microbiota with a low FODMAP diet	The patient will be asked for a stool sample before and after the diet, the microbiota were measure by PCR	Participants will be evaluated at weeks 1, 5 and 10
Secondary	Blood chemistry	Changes from baseline glucose, creatinine, high density lipoproteins, low density lipoproteins, cholesterol levels (mg/dL) at 10 weeks of nutritional intervention in patients with IBS and IBD	Participants will be evaluated at weeks 1 and 10
Secondary	Irritable Bowel Syndrome Severity Score	Changes from baseline in the presence or absence of gastrointestinal symptoms where the higher the score, more severity of symptoms are assesed using a percentage scale 0-100%, at 10 weeks with low FODMAP diet in patients wih IBS and IBD	Participants will be evaluated at weeks 1, 5 and 10
Secondary	Gastrointestinal Symptoms Severity	Changes from baseline of presence or abscense of gastrointestinal symptoms where the higher the score, the higher severity of symptoms (assesed using cualitative scale with options ranging from minimal symptoms to very annoying symptoms) at 10 weeks with low FODMAP diet in patients wih IBS and IBD	Participants will be evaluated at weeks 1, 5 and 10
Secondary	Anthropometric measurements	Changes from baseline of arm, waist and hips circumferences in centimeters at 12 weeks of nutritional intervention in patientes with IBS anda IBD	Participants will be evaluated at weeks 1, 5 and 10