Irritable Bowel SyndromeNCT05396651
Effect of Low Fermentable Oligosaccharides, Disaccharides ,Monosaccharides and Polyols (FODMAP) Diet on Control of Pediatric Irritable Bowel Syndrome and Quality of Life
A study testing low fodmap diet and NICE guidelines for IBS in people with Irritable Bowel Syndrome, run by Sarah Abdelrahman El Ezaby at 1 site in Egypt.
Trial summary
To evaluate the impact of low FODMAP diet on Health related Quality of life in children with Irritable bowel syndrome according to ROME IV criteria in a group of patients in pediatric Hospital at Ain Shams University Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- low fodmap diet and NICE guidelines for IBS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Oct 2020to 30 Jan 2022
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis
Who cannot join
- Patients presenting with :
- Abdominal pain or diarrhea that wakes the child from sleep
- Delay in onset or progression of puberty.
- Faltering growth.
- Family history of inflammatory bowel disease, celiac disease.
- History of significant weight loss .
Show all 11Show fewer
- Bleeding per rectum.
- Persistence of severe vomiting or diarrhea
- . Persistent joint pain.
- Recurrent unexplained fever.
- Unexplained pallor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Low Fodmap Diet on Control of Pediatric Irritable Bowel Syndrome
To evaluate the impact of low FODMAP diet on Health related Quality of life in children with Irritable bowel syndrome according to ROME IV criteria in a group of patients in pediatric Hospital at Ain Shams University
Read the detailed description
Single blinded randomized two-arm intervention study in which 42 patients with irritable bowel syndrome were enrolled to study the effect of LOW FODMAP diet ( intervention group) on their gastrointestinal symptoms and their quality of life another group of 42 patients of IBS were enrolled as a control group who were received general diet instructions and they followed the NICE guide lines for IBS management
- Conditions
- Irritable Bowel Syndrome
- Being tested
- low fodmap diet, NICE guidelines for IBS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low fodmap dietOther
elimination of high fodmap diet - High FODMAP diet: ice cream, soft cheese , yoghurt, cabbage , cauliflower, green bean, garlic, okra, onions, snow peas, broccoli, avocado , apple, mango , dates, watermelon, legumes , pulses, wheat , pasta , artificial sweeteners
NICE guidelines for IBSOther
follow NICE guidelines for IBS :have regular meals and take time to eat. avoid missing meals or leaving long gaps between eating. drink at least 8 cups of fluid per day, especially water or other non-caffeinated drinks, for example herbal teas.
restrict tea and coffee to 3 cups per day. reduce intake of alcohol and fizzy drinks.
| Study group | Role | What they receive |
|---|---|---|
| LOW FODMAP Diet group | Experimental | 42 Children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis, and didn't have any of the following :o Abdominal pain or diarrhea that wakes the child from sleep
* Delay in onset or progression of puberty.
* Faltering growth.
* Family history of inflammatory bowel disease, celiac disease.
* History of significant weight loss .
* Bleeding per rectum.
* Persistence of severe vomiting or diarrhea
* . Persistent joint pain.
* Recurrent unexplained fever.
* Unexplained pallor they followed the low fodmapdiet for 6 weeks Receives: Other: low fodmap diet |
| NICE guidelines group | Placebo comparator | 42 Children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis and didn't have one of the following : o Abdominal pain or diarrhea that wakes the child from sleep
* Delay in onset or progression of puberty.
* Faltering growth.
* Family history of inflammatory bowel disease, celiac disease.
* History of significant weight loss .
* Bleeding per rectum.
* Persistence of severe vomiting or diarrhea
* . Persistent joint pain.
* Recurrent unexplained fever.
* Unexplained pallor
they followed NICE guidelines for irritable bowel syndrome for 6 weeks Receives: Other: NICE guidelines for IBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of irritable bowel syndrome symproms
Change in Pediactric Quality of life inventory (PedsQL) gastrointestinal symptoms module score
Measured: 6 weeks
Secondary outcomes (1)
improve patients quality of life
Change in Pediatric quality of life inventory (PEDSQL) Generic core l score
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start2 Oct 2020
- Primary completion13 Jun 2021
- Study completion30 Jan 2022
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Abdelrahman El Ezaby
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Abdelrahman El Ezaby, Ain Shams University
- Investigators
- Diaa a Marzouk, professor, Study director, faculty of medicine ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396651
- Sponsor's protocol ID
- FMASU319/2019
- Status last verified
- May 2022
- First submitted
- 6 Mar 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Fodmap Diet on Control of Pediatric Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05396651
- Acronym / sponsor ID
- FMASU319/2019
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sarah Abdelrahman El EzabyUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 13 Jun 2021 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 31 May 2022 (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.
To evaluate the impact of low FODMAP diet on Health related Quality of life in children with Irritable bowel syndrome according to ROME IV criteria in a group of patients in pediatric Hospital at Ain Shams University
Detailed description
Single blinded randomized two-arm intervention study in which 42 patients with irritable bowel syndrome were enrolled to study the effect of LOW FODMAP diet ( intervention group) on their gastrointestinal symptoms and their quality of life another group of 42 patients of IBS were enrolled as a control group who were received general diet instructions and they followed the NICE guide lines for IBS management
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LOW FODMAP Diet group | Experimental | Other: low fodmap diet42 Children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis, and didn't have any of the following :o Abdominal pain or diarrhea that wakes the child from sleep * Delay in onset or progression of puberty. * Faltering growth. * Family history of inflammatory bowel disease, celiac disease. * History of significant weight loss . * Bleeding per rectum. * Persistence of severe vomiting or diarrhea * . Persistent joint pain. * Recurrent unexplained fever. * Unexplained pallor they followed the low fodmapdiet for 6 weeks |
| NICE guidelines group | Placebo comparator | Other: NICE guidelines for IBS42 Children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis and didn't have one of the following : o Abdominal pain or diarrhea that wakes the child from sleep * Delay in onset or progression of puberty. * Faltering growth. * Family history of inflammatory bowel disease, celiac disease. * History of significant weight loss . * Bleeding per rectum. * Persistence of severe vomiting or diarrhea * . Persistent joint pain. * Recurrent unexplained fever. * Unexplained pallor they followed NICE guidelines for irritable bowel syndrome for 6 weeks |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children aged 5-15 years old fulfilling ROME IV criteria of IBS diagnosis
Key exclusion criteria (11 listed)
- Abdominal pain or diarrhea that wakes the child from sleep
- Delay in onset or progression of puberty.
- Faltering growth.
- Family history of inflammatory bowel disease, celiac disease.
- History of significant weight loss .
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 |
|---|---|---|
| low fodmap dietelimination of high fodmap diet - High FODMAP diet: ice cream, soft cheese , yoghurt, cabbage , cauliflower, green bean, garlic, okra, onions, snow peas, broccoli, avocado , apple, mango , dates, watermelon, legumes , pulses, wheat , pasta , artificial sweeteners | Other | LOW FODMAP Diet group |
| NICE guidelines for IBSfollow NICE guidelines for IBS :have regular meals and take time to eat. avoid missing meals or leaving long gaps between eating. drink at least 8 cups of fluid per day, especially water or other non-caffeinated drinks, for example herbal teas. restrict tea and coffee to 3 cups per day. reduce intake of alcohol and fizzy drinks. | Other | NICE guidelines group |
Primary outcome
improvement of irritable bowel syndrome symproms
Time frame: 6 weeks
Change in Pediactric Quality of life inventory (PedsQL) gastrointestinal symptoms module score
1 secondary outcome
improve patients quality of life
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Diaa a Marzouk, professor study director
faculty of medicine ain shams 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 low fodmap diet and NICE guidelines for IBS in people with Irritable Bowel Syndrome, run by Sarah Abdelrahman El Ezaby 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 1 inclusion and 11 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: finished, as of the sponsor's last update on 1 Jun 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of irritable bowel syndrome symproms (time frame: 6 weeks). 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 1 Jun 2022.