Effects of Low FODMAP Diet Versus Gluten-free Diet on IBS Symptoms in ChildrenNCT02302703
Low FODMAP (Fermentable Oligo-,di-,Mono-saccharides and Polyols) Versus Gluten-free Diet in Pediatric IBS Patients; a Cross-over Randomized Trial.
A study testing low FODMAP diet vs Gluten free diet in people with Effects of Low FODMAP Diet Versus Gluten-free Diet on IBS Symptoms in Children, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Background: IBS (irritable bowel syndrome) describes chronic abdominal pain, which may be relieved with defecation and a change in stool frequency and consistency. Its prevalence among children and adolescents is estimated to be 10-15%. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Effects of Low FODMAP Diet Versus Gluten-free Diet on IBS Symptoms in Children
- What is being tested?
- low FODMAP diet vs Gluten free diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- May 2015to Jan 2017
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children who answer the pediatric ROME III criteria for IBS
Who cannot join
- Other diagnosis (e.g. inflammatory bowel disease, celiac disease).
- Patient receiving chronic medical therapy.
- Patient already on a restrictive diet (e.g. gluten-free, lactose-free)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Organization
Jerusalem
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
Maor Chavkin, MD
About this study
Background: IBS (irritable bowel syndrome) describes chronic abdominal pain, which may be relieved with defecation and a change in stool frequency and consistency. Its prevalence among children and adolescents is estimated to be 10-15%. Non-Celiac Gluten Sensitivity is defined as gastrointestinal symptoms which increase with eating gluten-containing foods and improve with a gluten-free diet. FODMAP (fermentable oligo-,di-,mono-saccharides and polyols) are carbohydrates that are not absorbed well in the small intestines, therefore fermented by gut microbiota, increasing osmotic load at the intestine causing fluid shift and gas production. The patient suffers bloating, abdominal pain, flatulence and change of stool consistency. Many foods are FODMAP-rich, including fruit and vegetables, legumes, artificial sweeteners and soft drinks.
Working hypothesis and aims: To study the effect of Low FODMAP diet vs. Gluten free on gastrointestinal symptoms in children with IBS, assuming a beneficial effect based on research in adults.
Read more
Methods: 40 children with IBS, aged 6-18 years, will be examined by the pediatric gastroenterology team at Hadassah. All children will record one week of baseline diet and symptoms, then will be randomly selected into a low-FODMAP or Gluten-free diet for one week, together with a washout period of one week between the diets. During the two weeks of intervention diets, the children aided by their parents will document and score symptoms (bowel movements, abdominal pain, flatulence). An analysis of the symptom score will measure the anticipated influence of each diet against baseline diet and symptoms.
Expected results: In previous studies, a change in symptoms was viewed within a few days. We expect to see a reduction of symptoms in one or other of the diets, to prove our hypothesis.
Read the detailed description
Outline of Study Design, including Plan of the Study and Methods:
Aims: comparing the effects of low FODMAP diet versus gluten-free diet on IBS symptoms in children.
Study design: prospective randomized, crossover trial. Study Population: we are aiming to recruit 40 children aged 6-18 years who answer the pediatric ROME III criteria for IBS. Children will be recruited to the study by physicians at pediatric gastroenterology clinics.
Exclusion criteria:
- Other diagnosis (e.g. inflammatory bowel disease, celiac disease).
- Patient receiving chronic medical therapy.
- Patient already on a restrictive diet (e.g. gluten-free, lactose-free) All patients will document baseline diet - a diary of 7 days by parents/patient specifying exact contents of meals. They will document and score baseline symptoms including stool consistency and frequency, abdominal pain, bloating and flatulence. The baseline documentation will be performed by the child, or by his parents, according to the patient's age and ability.
The patients will be randomly selected to one of the intervention groups. A clinical dietitian has created interventional diets. Half of the patients will start with the low FODMAP diet and half will start with Gluten free. After 7 days, the participants will return to a 7 days washout period of their regular diet. After this period, the groups will switch between the intervention diets, for additional 7 days. During the two weeks of intervention diets, the patients will document and score symptoms as described for the baseline documentation.
-There will be special consideration to several dietary elements in the baseline diet, e.g. patients who may regularly consume high lactose, gluten or FODMAP in their daily diet.
- Being tested
- low FODMAP diet vs Gluten free diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low FODMAP diet vs Gluten free dietOther
| Study group | Role | What they receive |
|---|---|---|
| the low FODMAP diet | Active comparator | Not described Receives: Other: low FODMAP diet vs Gluten free diet |
| Gluten free diet | Active comparator | Not described Receives: Other: low FODMAP diet vs Gluten free diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
abdominal pain score
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startMay 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Low FODMAP Diet Versus Gluten-free Diet on IBS Symptoms in ChildrenStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Crossover
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302703
- Sponsor's protocol ID
- fodmap1-HMO-CTIL
- Status last verified
- Nov 2014
- First submitted
- 25 Nov 2014
- Last updated
- 3 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low FODMAP (Fermentable Oligo-,di-,Mono-saccharides and Polyols) Versus Gluten-free Diet in Pediatric IBS Patients; a Cross-over Randomized Trial.
- ClinicalTrials.gov ID
- NCT02302703
- Acronym / sponsor ID
- fodmap1-HMO-CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017
- First posted
- 27 Nov 2014 (estimated)
- 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.
Background: IBS (irritable bowel syndrome) describes chronic abdominal pain, which may be relieved with defecation and a change in stool frequency and consistency. Its prevalence among children and adolescents is estimated to be 10-15%. Non-Celiac Gluten Sensitivity is defined as gastrointestinal symptoms which increase with eating gluten-containing foods and improve with a gluten-free diet. FODMAP (fermentable oligo-,di-,mono-saccharides and polyols) are carbohydrates that are not absorbed well in the small intestines, therefore fermented by gut microbiota, increasing osmotic load at the intestine causing fluid shift and gas production. The patient suffers bloating, abdominal pain, flatulence and change of stool consistency. Many foods are FODMAP-rich, including fruit and vegetables, legumes, artificial sweeteners and soft drinks.
Working hypothesis and aims: To study the effect of Low FODMAP diet vs. Gluten free on gastrointestinal symptoms in children with IBS, assuming a beneficial effect based on research in adults.
Methods: 40 children with IBS, aged 6-18 years, will be examined by the pediatric gastroenterology team at Hadassah. All children will record one week of baseline diet and symptoms, then will be randomly selected into a low-FODMAP or Gluten-free diet for one week, together with a washout period of one week between the diets. During the two weeks of intervention diets, the children aided by their parents will document and score symptoms (bowel movements, abdominal pain, flatulence). An analysis of the symptom score will measure the anticipated influence of each diet against baseline diet and symptoms.
Expected results: In previous studies, a change in symptoms was viewed within a few days. We expect to see a reduction of symptoms in one or other of the diets, to prove our hypothesis.
Detailed description
Outline of Study Design, including Plan of the Study and Methods:
Aims: comparing the effects of low FODMAP diet versus gluten-free diet on IBS symptoms in children.
Study design: prospective randomized, crossover trial. Study Population: we are aiming to recruit 40 children aged 6-18 years who answer the pediatric ROME III criteria for IBS. Children will be recruited to the study by physicians at pediatric gastroenterology clinics.
Exclusion criteria:
- Other diagnosis (e.g. inflammatory bowel disease, celiac disease).
- Patient receiving chronic medical therapy.
- Patient already on a restrictive diet (e.g. gluten-free, lactose-free) All patients will document baseline diet - a diary of 7 days by parents/patient specifying exact contents of meals. They will document and score baseline symptoms including stool consistency and frequency, abdominal pain, bloating and flatulence. The baseline documentation will be performed by the child, or by his parents, according to the patient's age and ability.
The patients will be randomly selected to one of the intervention groups. A clinical dietitian has created interventional diets. Half of the patients will start with the low FODMAP diet and half will start with Gluten free. After 7 days, the participants will return to a 7 days washout period of their regular diet. After this period, the groups will switch between the intervention diets, for additional 7 days. During the two weeks of intervention diets, the patients will document and score symptoms as described for the baseline documentation.
-There will be special consideration to several dietary elements in the baseline diet, e.g. patients who may regularly consume high lactose, gluten or FODMAP in their daily diet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the low FODMAP diet | Active comparator | Other: low FODMAP diet vs Gluten free diet |
| Gluten free diet | Active comparator | Other: low FODMAP diet vs Gluten free diet |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children who answer the pediatric ROME III criteria for IBS
Key exclusion criteria (3 listed)
- Other diagnosis (e.g. inflammatory bowel disease, celiac disease).
- Patient receiving chronic medical therapy.
- Patient already on a restrictive diet (e.g. gluten-free, lactose-free)
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 diet vs Gluten free diet | Other | Gluten free diet, the low FODMAP diet |
Primary outcome
abdominal pain score
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2016.
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.
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 vs Gluten free diet in people with Effects of Low FODMAP Diet Versus Gluten-free Diet on IBS Symptoms in Children, run by Hadassah Medical Organization at 1 site in Israel.
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 3 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 3 Mar 2016. 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 Israel. 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 Michael Wilschanski, Prof (9722-5845039, michaelwil@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abdominal pain score (time frame: 7 days). 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 3 Mar 2016.