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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Low FODMAP diet
Standard diet
Sponsored by
Hospital General de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IBD - Inflammatory Bowel Disease focused on measuring Irritable Bowel Syndrome, Ulcerative Colitis, Low FODMAP diet, Nutritional status, Standard diet

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nallely Bueno HernándezRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

FODMAP diet in Irritable Bowel Syndrome

FODMAP diet in Ulcerative Colitis

FODMAP diet in healthy patients

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Adherence to treatment
By 24 hour recalls during the ten weeks of the study and food frequencies at week one, five and ten.
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
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
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
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
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
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

Full Information

First Posted
October 8, 2019
Last Updated
October 28, 2019
Sponsor
Hospital General de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04143633
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital General de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBD - Inflammatory Bowel Disease, IBS - Irritable Bowel Syndrome, UC - Ulcerative Colitis
Keywords
Irritable Bowel Syndrome, Ulcerative Colitis, Low FODMAP diet, Nutritional status, Standard diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The patient doesn´t know the type of diet (standard or low FODMAP)
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FODMAP diet in Irritable Bowel Syndrome
Arm Type
Experimental
Arm Description
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.
Arm Title
FODMAP diet in Ulcerative Colitis
Arm Type
Experimental
Arm Description
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.
Arm Title
FODMAP diet in healthy patients
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low FODMAP diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nutritional status
Description
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
Time Frame
The patients will be evaluated at weeks 1 and 10
Secondary Outcome Measure Information:
Title
Quality of life in patients with Irritable Bowel Syndrome and Inflammatory Bowel Disease
Description
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
Time Frame
The patients will be evaluated at weeks 1, 5 and 10
Title
Adherence to treatment
Description
By 24 hour recalls during the ten weeks of the study and food frequencies at week one, five and ten.
Time Frame
The patients will be evaluated at weeks 1, 5 and 10
Title
Body composition analysis
Description
Changes from baseline of the percentage of body fat (%), muscle (%) and water (%) at 10 weeks of nutritional intervention, using RJL System IV
Time Frame
The patients will be evaluated at weeks 1, 5 and 10
Title
Gut microbiota with a low FODMAP diet
Description
The patient will be asked for a stool sample before and after the diet, the microbiota were measure by PCR
Time Frame
Participants will be evaluated at weeks 1, 5 and 10
Title
Blood chemistry
Description
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
Time Frame
Participants will be evaluated at weeks 1 and 10
Title
Irritable Bowel Syndrome Severity Score
Description
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
Time Frame
Participants will be evaluated at weeks 1, 5 and 10
Title
Gastrointestinal Symptoms Severity
Description
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
Time Frame
Participants will be evaluated at weeks 1, 5 and 10
Title
Anthropometric measurements
Description
Changes from baseline of arm, waist and hips circumferences in centimeters at 12 weeks of nutritional intervention in patientes with IBS anda IBD
Time Frame
Participants will be evaluated at weeks 1, 5 and 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nallely Bueno Hernández, PhD
Phone
27892000
Ext
5654
Email
nallely_bh5@yahoo.com.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Karen L de León Barrera, B.S
Email
nut.karendeleon@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nallely Bueno Hernádez, PhD
Organizational Affiliation
Hospital General de México
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nallely Bueno Hernández
City
Mexico City
State/Province
Cuauhtémoc
ZIP/Postal Code
06720
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nallely Bueno Hernández, PhD
Phone
27892000
Ext
5654
Email
dinvestigacionhgm@gmail.com
First Name & Middle Initial & Last Name & Degree
Karen L de León Barrera, B.S.
Email
nut.karendeleon@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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