The Impact of Dietary Treatment in Patients With Irritable Bowel Syndrome

NCT04307368 | Completed

• 1 other identifier: R-I-002/389/2015
• Study Type: interventional
• Target: 73
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome

Keywords

irritable bowel syndrome; diet

Outcome Measures

Primary Outcomes (9)

• 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).

  8 weeks

• 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.

  8 weeks

• 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.

  8 weeks

• 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.

  8 weeks

• 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

  8 weeks

• 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).

  8 weeks

• 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.

  8 weeks

• Assessment of body composition

  Assessment of body composition of subjects tested using the bioelectroimpedance method (MALTRON BioScan 920-2 by Maltron International LTD).

  8 weeks

• 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.

  8 weeks

Study Arms (3)

FODMAP diet

EXPERIMENTAL

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

Other: FODMAP diet

Elimination-rotational diet

EXPERIMENTAL

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.

Other: Elimination-rotational diet

Classic diet

EXPERIMENTAL

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

Other: Classic diet

Interventions

FODMAP diet OTHER

8 weeks of diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP)

FODMAP diet

Elimination-rotational diet OTHER

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.

Elimination-rotational diet

Classic diet OTHER

8 weeks of classic diet treatment (recommended by the gastroenterologist who supervises them).

Classic diet

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patients who use strong opioid and psychotropic drugs: barbiturates
• patients who have a pacemaker or heart defibrillator implanted and metal endoprostheses (due to the used body composition test method (BIA - Bioelectrical Impedance Analysis)

Sponsors & Collaborators

• Medical University of Bialystok: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Diana Wasiluk, MS, PhD

  Medical University of Bialystok

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: March 13, 2020
• Study Start: April 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 13, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share