NCT04307368

The Impact of Dietary Treatment in Patients With Irritable Bowel Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Medical University of Bialystok · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	FODMAP diet	8 weeks of diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP)
OTHER	Elimination-rotational diet	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	Classic diet	8 weeks of classic diet treatment (recommended by the gastroenterologist who supervises them).

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2020-03-13
• Last updated: 2020-03-13