- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05879692
Response of Irritable Bowel Syndrome to Abdominal Fat Reduction
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aly S Elrashidy, M.Sc.
- Phone Number: +201276755911
- Email: Alypek@yahoo.com
Study Contact Backup
- Name: Heba A Abd Elghaffar Ali, PhD
- Phone Number: +201005056590
- Email: hebaelshweety@gmail.com
Study Locations
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-
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Cairo, Egypt, 11697
- Recruiting
- El-Sahel Teaching Hospital
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Contact:
- Seham M Mahmoud, MD
- Phone Number: +201001710995
- Email: Amroo1954@gmail.com
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Contact:
- Aly S Elrashidy, MSc
- Phone Number: +201276755911
- Email: Alypek@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: study group (Group A)
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.
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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).
Other Names:
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.
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.
Other Names:
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Active Comparator: control group (Group B)
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.
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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).
Other Names:
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in total body fat percentage
Time Frame: change from baseline total body fat percentage at 12 weeks
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total body fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
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change from baseline total body fat percentage at 12 weeks
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change in abdominal subcutaneous fat percentage
Time Frame: change from baseline abdominal subcutaneous fat percentage at 12 weeks
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abdominal subcutaneous fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
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change from baseline abdominal subcutaneous fat percentage at 12 weeks
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change in abdominal visceral fat percentage
Time Frame: change from baseline abdominal visceral fat percentage at 12 weeks
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abdominal visceral fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
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change from baseline abdominal visceral fat percentage at 12 weeks
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change in Irritable bowel syndrome Severity Scoring system (IBS-SSS)
Time Frame: change from baseline Irritable bowel syndrome Severity Scoring system at 12 weeks
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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
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change from baseline Irritable bowel syndrome Severity Scoring system at 12 weeks
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change in Irritable bowel syndrome-quality of life (IBS-QOL)
Time Frame: change from baseline Irritable bowel syndrome-quality of life at 12 weeks
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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)
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change from baseline Irritable bowel syndrome-quality of life at 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in body weight
Time Frame: change from baseline body weight at 12 weeks
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Weight scale will be used to measure the weight (in kilograms) of all patients in both groups (A & B)
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change from baseline body weight at 12 weeks
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change in body mass index
Time Frame: change from baseline body mass index at 12 weeks
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Body Mass Index (BMI) is calculated as body weight (in kilograms) divided by the square of body height (in meters) (BMI= Kg/m²)
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change from baseline body mass index at 12 weeks
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change in waist circumference measurement
Time Frame: change from baseline Waist circumference at 12 weeks
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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
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change from baseline Waist circumference at 12 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aly S Elrashidy, M.Sc., Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004475
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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