Clinical trial NCT04143633: Low FODMAP Diet on Nutritional Status, Disease Activity and Gut Microbiota in IBS and UC With Normal or Overweight BMI
Official title: Low FODMAP Diet Chronic Effect on Nutritional Status, Disease Activity and Gut Microbiota in Patients With IBS and UC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IBD - Inflammatory Bowel Disease
IBS - Irritable Bowel Syndrome
UC - Ulcerative Colitis
Keywords: Irritable Bowel Syndrome
Ulcerative Colitis
Low FODMAP diet
Nutritional status
Standard diet
Lead sponsor: Hospital General de Mexico
Sponsor class: OTHER_GOV
First posted: 2019-10-29
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Nutritional status
timeFrame: The patients will be evaluated at weeks 1 and 10
Secondary outcomes:
measure: Quality of life in patients with Irritable Bowel Syndrome and Inflammatory Bowel Disease
timeFrame: The patients will be evaluated at weeks 1, 5 and 10
measure: Adherence to treatment
timeFrame: The patients will be evaluated at weeks 1, 5 and 10
measure: Body composition analysis
timeFrame: The patients will be evaluated at weeks 1, 5 and 10
measure: Gut microbiota with a low FODMAP diet
timeFrame: Participants will be evaluated at weeks 1, 5 and 10
measure: Blood chemistry
timeFrame: Participants will be evaluated at weeks 1 and 10
measure: Irritable Bowel Syndrome Severity Score
timeFrame: Participants will be evaluated at weeks 1, 5 and 10
measure: Gastrointestinal Symptoms Severity
timeFrame: Participants will be evaluated at weeks 1, 5 and 10
measure: Anthropometric measurements
timeFrame: Participants will be evaluated at weeks 1, 5 and 10
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Nallely Bueno Hernández
state: Cuauhtémoc
Study officials:
affiliation: Hospital General de México
name: Nallely Bueno Hernádez, PhD
role: PRINCIPAL_INVESTIGATOR
References: