Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
Study NCT ID:
NCT04307368
Status:
COMPLETED
Last Update Posted:
2020-03-13
First Post:
2020-02-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Dietary Treatment in Patients With Irritable Bowel Syndrome
Sponsor:
Medical University of Bialystok
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: