Irritable Bowel SyndromeNCT05879692
Response of Irritable Bowel Syndrome to Abdominal Fat Reduction
A study testing focused ultrasound, Low Caloric Diet (LCD) and a low (FODMAPs) diet and aerobic exercise in people with Irritable Bowel Syndrome and Obesity, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Irritable Bowel Syndrome, Obesity, Abdominal Obesity
- What is being tested?
- focused ultrasound, Low Caloric Diet (LCD) and a low (FODMAPs) diet and aerobic exercise
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 28 May 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
El-Sahel Teaching Hospital
Cairo, 11697
Aly S Elrashidy, MSc, +201276755911, Alypek@yahoo.com
Seham M Mahmoud, MD, +201001710995, Amroo1954@gmail.com
About this study
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).
Read the 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.
- Conditions
- Irritable Bowel Syndrome, Obesity, Abdominal Obesity
- Being tested
- focused ultrasound, Low Caloric Diet (LCD) and a low (FODMAPs) diet, aerobic exercise
- Keywords
- Irritable Bowel Syndrome, abdominal fat, central obesity, high intensity focused ultrasound, FODMAPs diet
- Medical subject headings
- Irritable Bowel Syndrome, Obesity, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focused ultrasoundProcedure or surgery
Also called cavitation
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.
Low Caloric Diet (LCD) and a low (FODMAPs) dietBehavioural
Also called dietary regimen
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).
aerobic exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| study group (Group A) | Experimental | 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. Receives: Procedure: focused ultrasound; Behavioral: Low Caloric Diet (LCD) and a low (FODMAPs) diet; Other: aerobic exercise |
| control group (Group B) | Active comparator | 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. Receives: Behavioral: Low Caloric Diet (LCD) and a low (FODMAPs) diet; Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in total body fat percentage
total body fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
Measured: change from baseline total body fat percentage at 12 weeks
change in abdominal subcutaneous fat percentage
abdominal subcutaneous fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
Measured: change from baseline abdominal subcutaneous fat percentage at 12 weeks
change in abdominal visceral fat percentage
abdominal visceral fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
Measured: change from baseline abdominal visceral fat percentage at 12 weeks
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
Measured: change from baseline Irritable bowel syndrome Severity Scoring system at 12 weeks
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)
Measured: change from baseline Irritable bowel syndrome-quality of life at 12 weeks
Secondary outcomes (3)
change in body weight
Weight scale will be used to measure the weight (in kilograms) of all patients in both groups (A \& B)
Measured: change from baseline body weight at 12 weeks
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)
Measured: change from baseline body mass index at 12 weeks
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
Measured: change from baseline Waist circumference at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start28 May 2023
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aly Elrashidy, Cairo University
- Investigators
- Aly S Elrashidy, M.Sc., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879692
- Sponsor's protocol ID
- P.T.REC/012/004475
- Status last verified
- Jul 2023
- First submitted
- 5 May 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Irritable Bowel Syndrome to Abdominal Fat Reduction
- ClinicalTrials.gov ID
- NCT05879692
- Acronym / sponsor ID
- P.T.REC/012/004475
- Conditions
- Irritable Bowel Syndrome, Obesity, Abdominal Obesity
- Keywords
- Irritable Bowel Syndrome, abdominal fat, central obesity, high intensity focused ultrasound, FODMAPs diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 May 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group (Group A) | Experimental | Procedure: focused ultrasound, Behavioral: Low Caloric Diet (LCD) and a low (FODMAPs) diet, Other: aerobic exerciseWill 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. |
| control group (Group B) | Active comparator | Behavioral: Low Caloric Diet (LCD) and a low (FODMAPs) diet, Other: aerobic exerciseWill 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- • Under 20 or above 45 years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| focused ultrasoundAlso: cavitationfocused 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. | Procedure or surgery | study group (Group A) |
| Low Caloric Diet (LCD) and a low (FODMAPs) dietAlso: dietary regimenThe 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). | Behavioural | control group (Group B), study group (Group A) |
| aerobic exerciseaerobic 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. | Other | control group (Group B), study group (Group A) |
Primary outcome
change in total body fat percentage
Time frame: change from baseline total body fat percentage at 12 weeks
total body fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
change in abdominal subcutaneous fat percentage
Time frame: change from baseline abdominal subcutaneous fat percentage at 12 weeks
abdominal subcutaneous fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
change in abdominal visceral fat percentage
Time frame: change from baseline abdominal visceral fat percentage at 12 weeks
abdominal visceral fat percentage will be measured by Dual-energy X-ray Absorptiometry (DXA)
change in Irritable bowel syndrome Severity Scoring system (IBS-SSS)
Time frame: change from baseline Irritable bowel syndrome Severity Scoring system at 12 weeks
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)
Time frame: change from baseline Irritable bowel syndrome-quality of life at 12 weeks
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)
3 secondary outcomes
change in body weight
Time frame: change from baseline body weight at 12 weeks
change in body mass index
Time frame: change from baseline body mass index at 12 weeks
change in waist circumference measurement
Time frame: change from baseline Waist circumference at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aly S Elrashidy, M.Sc. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing focused ultrasound, Low Caloric Diet (LCD) and a low (FODMAPs) diet and aerobic exercise in people with Irritable Bowel Syndrome and Obesity, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aly S Elrashidy, M.Sc. (+201276755911, Alypek@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in total body fat percentage (time frame: change from baseline total body fat percentage at 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.