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Response of Irritable Bowel Syndrome to Abdominal Fat Reduction

Primary Purpose

Irritable Bowel Syndrome, Obesity, Abdominal Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
focused ultrasound
Low Caloric Diet (LCD) and a low (FODMAPs) diet
aerobic exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, abdominal fat, central obesity, high intensity focused ultrasound, FODMAPs diet

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • El-Sahel Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study group (Group A)

control group (Group B)

Arm Description

Will consist of 30 cases suffering from mild to moderate Irritable Bowel Syndrome (IBS) with mild to moderate obesity will receive High Intensity Focused Ultrasound (Cavitation), a dietary regimen that combines Low Caloric Diet (LCD) and low (FODMAPs) diet and aerobic exercises with moderate intensity.

Will consist of 30 cases suffering from mild to moderate Irritable Bowel Syndrome (IBS) with mild to moderate obesity will receive only the same dietary regimen and aerobic exercise that prescribed for group A.

Outcomes

Primary Outcome Measures

change in total body fat percentage
total body fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
change in abdominal subcutaneous fat percentage
abdominal subcutaneous fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
change in abdominal visceral fat percentage
abdominal visceral fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
change in Irritable bowel syndrome Severity Scoring system (IBS-SSS)
The Irritable bowel syndrome Severity Scoring System (IBS-SSS) questionnaire was validated by Francis et al. in 1997and consists of five questions that measure: (1) abdominal pain severity; (2) frequency (number of days in every 10 days) with abdominal pain; (3) abdominal bloating/distension; (4) satisfaction with bowel habits; (5) IBS-related quality of life (QoL). Each measure is rated from 0 to 100, with total scores ranging from 0 to 500
change in Irritable bowel syndrome-quality of life (IBS-QOL)
The Irritable bowel syndrome-quality of life questionnaire (IBS-QOL) consists of 34 items assessing patients' well-being across eight subscales: dysphoria (eight items); interference with activity (seven items); body image (four items); social reaction (four items); health worry (three items); food avoidance (three items); relationships (three items); and sexual (two items)

Secondary Outcome Measures

change in body weight
Weight scale will be used to measure the weight (in kilograms) of all patients in both groups (A & B)
change in body mass index
Body Mass Index (BMI) is calculated as body weight (in kilograms) divided by the square of body height (in meters) (BMI= Kg/m²)
change in waist circumference measurement
Waist circumference (WC) will be measured (in centimeters) by the tape measurement at the midway between the lowest rib and the iliac crest, while the patient in the standing position with light clothes and at the end of expiration

Full Information

First Posted
May 5, 2023
Last Updated
July 12, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05879692
Brief Title
Response of Irritable Bowel Syndrome to Abdominal Fat Reduction
Official Title
Response of Irritable Bowel Syndrome to Abdominal Fat Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 28, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Obesity, Abdominal Obesity
Keywords
Irritable Bowel Syndrome, abdominal fat, central obesity, high intensity focused ultrasound, FODMAPs diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group (Group A)
Arm Type
Experimental
Arm Description
Will consist of 30 cases suffering from mild to moderate Irritable Bowel Syndrome (IBS) with mild to moderate obesity will receive High Intensity Focused Ultrasound (Cavitation), a dietary regimen that combines Low Caloric Diet (LCD) and low (FODMAPs) diet and aerobic exercises with moderate intensity.
Arm Title
control group (Group B)
Arm Type
Active Comparator
Arm Description
Will consist of 30 cases suffering from mild to moderate Irritable Bowel Syndrome (IBS) with mild to moderate obesity will receive only the same dietary regimen and aerobic exercise that prescribed for group A.
Intervention Type
Procedure
Intervention Name(s)
focused ultrasound
Other Intervention Name(s)
cavitation
Intervention Description
focused ultra sound cavitation using a device of Mabel6 DUO Ultra Cavitation Technology system produced by DAEYANG MEDICAL COMPANY, KOREA will be applied on the abdominal region which extending bilaterally from the line extending from mid axilla to iliac crest, and above from center of diaphragm to the line extending between two iliac crest below. the session of Focused Ultra Sound will take 25- 30 minutes, twice/week and with about three day intervals for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Low Caloric Diet (LCD) and a low (FODMAPs) diet
Other Intervention Name(s)
dietary regimen
Intervention Description
The Low caloric diet (LCD) diet will be an equilibrated diet that had a caloric value 10% below the total metabolic expenditure (total energy expenditure) of each individual. The low FODMAPs diet (LFD) is a diet low in fermentable oligo-, di-, mono- saccharides and polyols (FODMAPs).
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Intervention Description
aerobic exercise program under direct supervision at a frequency of 3 times/week for 12 weeks, in the form of walking on a treadmill for 30 minutes with moderate intensity (12-14) according to The Borg Rating of Perceived Exertion (RPE) scale.
Primary Outcome Measure Information:
Title
change in total body fat percentage
Description
total body fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
Time Frame
change from baseline total body fat percentage at 12 weeks
Title
change in abdominal subcutaneous fat percentage
Description
abdominal subcutaneous fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
Time Frame
change from baseline abdominal subcutaneous fat percentage at 12 weeks
Title
change in abdominal visceral fat percentage
Description
abdominal visceral fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
Time Frame
change from baseline abdominal visceral fat percentage at 12 weeks
Title
change in Irritable bowel syndrome Severity Scoring system (IBS-SSS)
Description
The Irritable bowel syndrome Severity Scoring System (IBS-SSS) questionnaire was validated by Francis et al. in 1997and consists of five questions that measure: (1) abdominal pain severity; (2) frequency (number of days in every 10 days) with abdominal pain; (3) abdominal bloating/distension; (4) satisfaction with bowel habits; (5) IBS-related quality of life (QoL). Each measure is rated from 0 to 100, with total scores ranging from 0 to 500
Time Frame
change from baseline Irritable bowel syndrome Severity Scoring system at 12 weeks
Title
change in Irritable bowel syndrome-quality of life (IBS-QOL)
Description
The Irritable bowel syndrome-quality of life questionnaire (IBS-QOL) consists of 34 items assessing patients' well-being across eight subscales: dysphoria (eight items); interference with activity (seven items); body image (four items); social reaction (four items); health worry (three items); food avoidance (three items); relationships (three items); and sexual (two items)
Time Frame
change from baseline Irritable bowel syndrome-quality of life at 12 weeks
Secondary Outcome Measure Information:
Title
change in body weight
Description
Weight scale will be used to measure the weight (in kilograms) of all patients in both groups (A & B)
Time Frame
change from baseline body weight at 12 weeks
Title
change in body mass index
Description
Body Mass Index (BMI) is calculated as body weight (in kilograms) divided by the square of body height (in meters) (BMI= Kg/m²)
Time Frame
change from baseline body mass index at 12 weeks
Title
change in waist circumference measurement
Description
Waist circumference (WC) will be measured (in centimeters) by the tape measurement at the midway between the lowest rib and the iliac crest, while the patient in the standing position with light clothes and at the end of expiration
Time Frame
change from baseline Waist circumference at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aly S Elrashidy, M.Sc.
Phone
+201276755911
Email
Alypek@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Heba A Abd Elghaffar Ali, PhD
Phone
+201005056590
Email
hebaelshweety@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aly S Elrashidy, M.Sc.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
El-Sahel Teaching Hospital
City
Cairo
ZIP/Postal Code
11697
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aly S Elrashidy, MSc
Phone
+201276755911
Email
Alypek@yahoo.com
First Name & Middle Initial & Last Name & Degree
Seham M Mahmoud, MD
Phone
+201001710995
Email
Amroo1954@gmail.com

12. IPD Sharing Statement

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Response of Irritable Bowel Syndrome to Abdominal Fat Reduction

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