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The Impact of Dietary Treatment in Patients With Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FODMAP diet
Elimination-rotational diet
Classic diet
Sponsored by
Medical University of Bialystok
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring irritable bowel syndrome, diet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. patients with irritable bowel syndrome (mixed) according to Rome III Criteria, in whom the gastroenterologist does not find any other gastrointestinal diseases that may affect this study
  2. patients who understand the purpose and nature of the study, agree to its terms and give informed written consent before entering the study
  3. who are physically and mentally able to participate in the study and express their will to cooperate

Exclusion Criteria:

  1. patients who use strong opioid and psychotropic drugs: barbiturates
  2. patients who take part in another clinical trial related to the treatment of gastrointestinal diseases or dietary therapy within 90 days prior to inclusion in this study
  3. patients who have a pacemaker or heart defibrillator implanted and metal endoprostheses (due to the used body composition test method (BIA - Bioelectrical Impedance Analysis)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    FODMAP diet

    Elimination-rotational diet

    Classic diet

    Arm Description

    Patients with IBS. Interventions: 8 weeks of diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP)

    Patients with IBS. Interventions: During the patient's first visit an IgG antibody titration test against specific nutrients will be performed to determine food hypersensitivity. Based on the results of the obtained food panels, patients will be offered an elimination-rotational diet for a period of 8 weeks.

    Patients with IBS. Interventions: 8 weeks of classic diet treatment (recommended by the gastroenterologist who supervises them).

    Outcomes

    Primary Outcome Measures

    Comparative analysis of selected clinical symptoms of IBS patients before and after 8 weeks of nutritional intervention.
    During the first visit, each applicant will receive a detailed interview on sociodemographic characteristics, lifestyle and professional work. The interview questionnaire contains questions about the most common symptoms of the disease (including abdominal pain, flatulence, stool disorders).
    Assessment of intestinal inflammation in patients with irritable bowel syndrome (before and after 8 weeks of using the recommended diet).
    Intestinal inflammation was assessed by faecal calprotectin. At the first visit, each patient must bring a stool sample to assess calprotectin levels. The test will be carried out normalized and certified by Elisa.
    Comparative analysis of the quality of life of IBS patients before and after 8 weeks of nutritional intervention.
    The current quality of life for patients with irritable bowel syndrome will be assessed using the IBS-QOL (Irritable Bowel Syndrome-Quality Of Life Questionnaire); total score between 34 -170 points, the highest sum means the most reduced quality of life.
    Comparative analysis of the nutritional value of diets used before the study and after 8 weeks of dietary treatment using the FODMAP diet, elimination-rotation and conventional.
    Quantitative diet assessment was based on a 24h diet recall from 3 days preceding the study. The respondents estimated the amount of each food and ingredient consumed. The results from each patient were averaged in accordance with the adopted recommendations of the Institute of Food and Nutrition in Warsaw and the nutritional value of daily food rations was analyzed using Dieta 5.0 software calculating the average intake of the energy, nutrients, vitamins, minerals, cholesterol and dietary fibre.
    Individually calculated Body Mass Index
    Individually calculated BMI (Body Mass Index) - this is the ratio obtained by dividing the body weight in kilograms by the square of the height in meters
    Individually calculated Waist-Hip Ratio
    Individually calculated WHR (Waist-Hip Ratio) - coefficient resulting from dividing the waist circumference by the hip circumference (measurements made in centimeters).
    Assessment of nutrients causing food hypersensitivity (IgG1-3)
    The baseline reaction of alimentary IgG1-3 in blood serum was measured in μg/ml in the ranges: <7.5 μg/ml - not elevated, ≥7.5 μg/ml - increased and ≥20.0 μg/ml - significantly increased.
    Assessment of body composition
    Assessment of body composition of subjects tested using the bioelectroimpedance method (MALTRON BioScan 920-2 by Maltron International LTD).
    Pain intesity
    Pain intensity will be assessed using the VAS (Visual Analogue Scale) numerical scale; total score between 0 -10 points, the higher the value the stronger the pain.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 25, 2020
    Last Updated
    March 12, 2020
    Sponsor
    Medical University of Bialystok
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04307368
    Brief Title
    The Impact of Dietary Treatment in Patients With Irritable Bowel Syndrome
    Official Title
    The Impact of Dietary Treatment Using a Low FODMAP Diet on the Occurrence of Selected Intestinal Bacteria and the Clinical Condition of Patients With Irritable Bowel Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2016 (Actual)
    Primary Completion Date
    December 2018 (Actual)
    Study Completion Date
    December 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of Bialystok

    4. Oversight

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

    5. Study Description

    Brief Summary
    The obtained results are likely to determine whether changes in the diet of patients with irritable bowel syndrome will affect their nutritional status. They will also allow you to assess whether dietary treatment will affect the resolution or alleviation, or severity of disease symptoms in IBS. The test results can be used in clinical practice. Participation in the study does not carry any risk of complications associated with undergoing a medical experiment.
    Detailed Description
    This is a randomized, parallel study that includes 1 initial visit and 1 final visit, separated by 8 weeks of diet. The investigators enrolled 73 women in the study, who met the criteria for inclusion in the study, to determine whether changes in the diet of patients with irritable bowel syndrome will affect their nutritional status. At the initial and final visit (after 8 weeks) in all patients, anthropometric measurements, body composition, an interview questionnaire concerning the symptoms of the disease was performed, the intensity of abdominal pain was assessed, the life quality of patients on the IBS-QOL scale was assessed, the calprotectin concentration in the stool was determined and the questionnaire regarding the quantitative assessment of diet was performed. The study population was divided using simple lottery into 3 groups with different dietary treatment for 8 weeks: group 1 - 26 patients - diet with low content of easily fermenting carbohydrates (FODMAP), group 2 - 21 patients - an elimination-rotation diet, and group 3 - (control) - 26 patients - classic diet treatment (recommended by the leading gastroenterologist).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome
    Keywords
    irritable bowel syndrome, diet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    73 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    FODMAP diet
    Arm Type
    Experimental
    Arm Description
    Patients with IBS. Interventions: 8 weeks of diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP)
    Arm Title
    Elimination-rotational diet
    Arm Type
    Experimental
    Arm Description
    Patients with IBS. Interventions: During the patient's first visit an IgG antibody titration test against specific nutrients will be performed to determine food hypersensitivity. Based on the results of the obtained food panels, patients will be offered an elimination-rotational diet for a period of 8 weeks.
    Arm Title
    Classic diet
    Arm Type
    Experimental
    Arm Description
    Patients with IBS. Interventions: 8 weeks of classic diet treatment (recommended by the gastroenterologist who supervises them).
    Intervention Type
    Other
    Intervention Name(s)
    FODMAP diet
    Intervention Description
    8 weeks of diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP)
    Intervention Type
    Other
    Intervention Name(s)
    Elimination-rotational diet
    Intervention Description
    During the patient's first visit an IgG antibody titration test against specific nutrients will be performed to determine food hypersensitivity. Based on the results of the obtained food panels, patients will be offered an elimination-rotational diet for a period of 8 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Classic diet
    Intervention Description
    8 weeks of classic diet treatment (recommended by the gastroenterologist who supervises them).
    Primary Outcome Measure Information:
    Title
    Comparative analysis of selected clinical symptoms of IBS patients before and after 8 weeks of nutritional intervention.
    Description
    During the first visit, each applicant will receive a detailed interview on sociodemographic characteristics, lifestyle and professional work. The interview questionnaire contains questions about the most common symptoms of the disease (including abdominal pain, flatulence, stool disorders).
    Time Frame
    8 weeks
    Title
    Assessment of intestinal inflammation in patients with irritable bowel syndrome (before and after 8 weeks of using the recommended diet).
    Description
    Intestinal inflammation was assessed by faecal calprotectin. At the first visit, each patient must bring a stool sample to assess calprotectin levels. The test will be carried out normalized and certified by Elisa.
    Time Frame
    8 weeks
    Title
    Comparative analysis of the quality of life of IBS patients before and after 8 weeks of nutritional intervention.
    Description
    The current quality of life for patients with irritable bowel syndrome will be assessed using the IBS-QOL (Irritable Bowel Syndrome-Quality Of Life Questionnaire); total score between 34 -170 points, the highest sum means the most reduced quality of life.
    Time Frame
    8 weeks
    Title
    Comparative analysis of the nutritional value of diets used before the study and after 8 weeks of dietary treatment using the FODMAP diet, elimination-rotation and conventional.
    Description
    Quantitative diet assessment was based on a 24h diet recall from 3 days preceding the study. The respondents estimated the amount of each food and ingredient consumed. The results from each patient were averaged in accordance with the adopted recommendations of the Institute of Food and Nutrition in Warsaw and the nutritional value of daily food rations was analyzed using Dieta 5.0 software calculating the average intake of the energy, nutrients, vitamins, minerals, cholesterol and dietary fibre.
    Time Frame
    8 weeks
    Title
    Individually calculated Body Mass Index
    Description
    Individually calculated BMI (Body Mass Index) - this is the ratio obtained by dividing the body weight in kilograms by the square of the height in meters
    Time Frame
    8 weeks
    Title
    Individually calculated Waist-Hip Ratio
    Description
    Individually calculated WHR (Waist-Hip Ratio) - coefficient resulting from dividing the waist circumference by the hip circumference (measurements made in centimeters).
    Time Frame
    8 weeks
    Title
    Assessment of nutrients causing food hypersensitivity (IgG1-3)
    Description
    The baseline reaction of alimentary IgG1-3 in blood serum was measured in μg/ml in the ranges: <7.5 μg/ml - not elevated, ≥7.5 μg/ml - increased and ≥20.0 μg/ml - significantly increased.
    Time Frame
    8 weeks
    Title
    Assessment of body composition
    Description
    Assessment of body composition of subjects tested using the bioelectroimpedance method (MALTRON BioScan 920-2 by Maltron International LTD).
    Time Frame
    8 weeks
    Title
    Pain intesity
    Description
    Pain intensity will be assessed using the VAS (Visual Analogue Scale) numerical scale; total score between 0 -10 points, the higher the value the stronger the pain.
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with irritable bowel syndrome (mixed) according to Rome III Criteria, in whom the gastroenterologist does not find any other gastrointestinal diseases that may affect this study patients who understand the purpose and nature of the study, agree to its terms and give informed written consent before entering the study who are physically and mentally able to participate in the study and express their will to cooperate Exclusion Criteria: patients who use strong opioid and psychotropic drugs: barbiturates patients who take part in another clinical trial related to the treatment of gastrointestinal diseases or dietary therapy within 90 days prior to inclusion in this study patients who have a pacemaker or heart defibrillator implanted and metal endoprostheses (due to the used body composition test method (BIA - Bioelectrical Impedance Analysis)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Diana Wasiluk, MS, PhD
    Organizational Affiliation
    Medical University of Bialystok
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Impact of Dietary Treatment in Patients With Irritable Bowel Syndrome

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