Clinical trial NCT04307368: 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
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: irritable bowel syndrome
diet
Lead sponsor: Medical University of Bialystok
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Comparative analysis of selected clinical symptoms of IBS patients before and after 8 weeks of nutritional intervention.
timeFrame: 8 weeks
measure: Assessment of intestinal inflammation in patients with irritable bowel syndrome (before and after 8 weeks of using the recommended diet).
timeFrame: 8 weeks
measure: Comparative analysis of the quality of life of IBS patients before and after 8 weeks of nutritional intervention.
timeFrame: 8 weeks
measure: 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.
timeFrame: 8 weeks
measure: Individually calculated Body Mass Index
timeFrame: 8 weeks
measure: Individually calculated Waist-Hip Ratio
timeFrame: 8 weeks
measure: Assessment of nutrients causing food hypersensitivity (IgG1-3)
timeFrame: 8 weeks
measure: Assessment of body composition
timeFrame: 8 weeks
measure: Pain intesity
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of Bialystok
name: Diana Wasiluk, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: