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The purpose of the study is to find out the response of Irritable Bowel Syndrome (IBS) to abdominal fat reduction in central obese patients using: application of High Intensity Focused Ultrasound (cavitation) on the abdominal region, aerobic exercise and a dietary regimen that will be low in calories (Low Caloric Diet) and low in fermentable oligo-, di-, mono- saccharides and polyols (low-FODMAPs).
Irritable bowel syndrome is a common functional gastrointestinal (GI) disorder, with a high global prevalence and a strong impact on the quality of life. There is a positive association between irritable bowel syndrome (IBS) and increased BMI and volume of android fat, according to waist circumference. Central obesity and Irritable Bowel Syndrome (IBS) are common medical conditions with similar etiologic mechanisms. There are several studies considering obesity as the risk factor for (IBS), but limited studies that to evaluate the association between abdominal obesity and the incidence of irritable bowel syndrome (IBS). Establishing such association is important in the management of IBS. Focused ultra sound cavitation is a noninvasive safe technique for reducing localized subcutaneous adipose tissue by generating molecular vibrations that elevate the local tissue temperature and produce rapid cell necrosis in targeted tissues. the investigators believe that focused ultrasound cavitation could improve the overall of Irritable Bowel Syndrome severity as a consequence of abdominal fat reduction. To the best of the investigators' knowledge, there are limited studies to confirm the improvement of irritable bowel syndrome (IBS) as a result of abdominal fat reduction by focused ultrasound cavitation. Therefore, this study is a trial to investigate the effect of focused ultrasound cavitation augmented with aerobic exercise and dietary regimen on improvement of Irritable bowel syndrome (IBS) in patients with central obesity. Sixty volunteer central obese patients (males and females) with Irritable Bowel Syndrome (IBS) which will be diagnosed according to Rome IV criteria will be participated in this study and will be referred from the Gastroenterology outpatient clinic of El-Sahel Teaching Hospital, Cairo. The study will be conducted at El-Sahel Teaching Hospital.
Age
20 - 45 years
Sex
ALL
Healthy Volunteers
No
El-Sahel Teaching Hospital
Cairo, Egypt
Start Date
May 28, 2023
Primary Completion Date
October 1, 2023
Completion Date
December 1, 2023
Last Updated
July 14, 2023
60
ESTIMATED participants
focused ultrasound
PROCEDURE
Low Caloric Diet (LCD) and a low (FODMAPs) diet
BEHAVIORAL
aerobic exercise
OTHER
Lead Sponsor
Cairo University
NCT01143454
NCT07472881
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