The Impact of Dietary Treatment in Patients With Irritable Bowel Syndrome

Medical University of Bialystok

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Other: Classic diet; Other: Elimination-rotational diet; Other: FODMAP diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04307368

R-I-002/389/2015

Details and patient eligibility

About

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.

Full 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).

Enrollment: 73 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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73 participants in 3 patient groups

FODMAP diet

Experimental group

Description:

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

Treatment:

Other: FODMAP diet

Elimination-rotational diet

Experimental group

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.

Treatment:

Other: Elimination-rotational diet

Classic diet

Experimental group

Description:

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

Treatment:

Other: Classic diet