Clinical trial NCT05879692: Response of Irritable Bowel Syndrome to Abdominal Fat Reduction
Official title: Response of Irritable Bowel Syndrome to Abdominal Fat Reduction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Obesity
Abdominal Obesity
Keywords: Irritable Bowel Syndrome
abdominal fat
central obesity
high intensity focused ultrasound
FODMAPs diet
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients will be 20-45 years of age.
* Both genders will be participated.
* sedentary (exercise \< 2 times/week).
* Body mass index (BMI) will be ranged from 30 to 39.9 kg/m² and their waist circumference ≥ 102 cm for men and ≥ 88 cm for women.
* Patients will have the criteria of Irritable Bowel Syndrome (IBS) according to Rome IV Which are: recurrent abdominal pain on average at least one day per week during the previous three months associated with two or more of the following features must fulfill: (1) Pain is related to defecation; (2) Pain associated with a change in frequency of stool; and (3) Pain associated with a change in form or appearance of stool.
* mild to moderate Irritable Bowel Syndrome with score of 75- 300 according to the questionnaire of Irritable Bowel Syndrome Severity Scoring System (IBS-SSS).

Exclusion Criteria:

* • Under 20 or above 45 years of age.

  * Athletics
  * Musculoskeletal, Carcinogenic, or kidney diseases, diabetes, hepatitis and cardiac disorders.
  * Any condition that may prevent the use of the focused ultrasound on the abdominal region such as scarring, hernias or skin diseases in the abdominal area.
  * Patients with severe Irritable Bowel Syndrome (IBS) or other known organic gastrointestinal disorders rather than IBS including: (1) Fever, Weight loss or Jaundice; (2) Change in the color of stool; (3) Signs of anemia or Thyroid disease; (4) Abdominal mass or Organomegaly; (5) Signs of intestinal obstruction.

Primary outcomes:
measure: change in total body fat percentage
timeFrame: change from baseline total body fat percentage at 12 weeks
measure: change in abdominal subcutaneous fat percentage
timeFrame: change from baseline abdominal subcutaneous fat percentage at 12 weeks
measure: change in abdominal visceral fat percentage
timeFrame: change from baseline abdominal visceral fat percentage at 12 weeks
measure: change in Irritable bowel syndrome Severity Scoring system (IBS-SSS)
timeFrame: change from baseline Irritable bowel syndrome Severity Scoring system at 12 weeks
measure: change in Irritable bowel syndrome-quality of life (IBS-QOL)
timeFrame: change from baseline Irritable bowel syndrome-quality of life at 12 weeks
Secondary outcomes:
measure: change in body weight
timeFrame: change from baseline body weight at 12 weeks
measure: change in body mass index
timeFrame: change from baseline body mass index at 12 weeks
measure: change in waist circumference measurement
timeFrame: change from baseline Waist circumference at 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El-Sahel Teaching Hospital
Study officials:
affiliation: Cairo University
name: Aly S Elrashidy, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References: