Inflammatory Bowel DiseasesFODMAPsNCT03644602
Low FODMAPs Diet in Gastrointestinal Disorders
A study testing low FODMAPs diet in people with Inflammatory Bowel Diseases and Irritable Bowel Syndrome, run by Federico II University at 1 site in Italy.
Trial summary
Recent studies have shown that FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) free diet is efficient in subjects with Irritable Bowel Syndrome (IBS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Coeliac Disease
- What is being tested?
- low FODMAPs diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2016to Dec 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- IBS patients
- IBD patients in remission
- Coeliac patients on gluten free diet
Who cannot join
- Active IBD
- Coeliac patients non compliant to gluten free diet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Beneficial Effects of a Low FODMAPs Diet in Different Gastrointestinal Disorders
Recent studies have shown that FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) free diet is efficient in subjects with Irritable Bowel Syndrome (IBS). Patients with Inflammatory Bowel Diseases (IBD) and celiac disease (CD) can experience functional gastrointestinal symptoms not related to inflammation, but data about the use of low FODMAPs diet in these settings are still scarce. The aim of the present study was to evaluate the usefulness of a low FODMAPs diet in patients with IBS, non-active IBD and CD on strict gluten-free diet (GFD). A low FODMAPs diet could be a valid option to contrast abdominal symptoms in patients with IBS, non-active IBD and CD on GFD, thus improving the quality of life and the social relations.
Read the detailed description
Recurrent gastrointestinal symptoms (bloating, constipation, abdominal pain, diarrhea and flatulence) often interfere with patients' quality of life (QoL) and daily activities. These symptoms have been noted in various diseases such as irritable bowel syndrome (IBS), celiac disease (CD) and inflammatory bowel diseases (IBD). IBS is the most common diagnosis made by gastroenterologists and affects up to 15% of the population. About 60% of patients with IBS claims that certain foods can exacerbate their symptoms, so pharmacological treatment is often accompanied by dietary measures. Very recently, a diet for the management of functional symptoms associated with IBS has been developed: the low FODMAPs diet. FODMAPs (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) is a collective term that indicates a family of poorly absorbed short-chain carbohydrates. The low FODMAPs diet is a relatively novel area of interest and the majority of studies have been performed in patients with IBS; most of them showed that limiting FODMAPs led to an improvement of intestinal symptoms. Patients with Crohn's disease (CrD) and ulcerative colitis (UC) often experience symptoms related to concomitant functional disease, such as bloating, abdominal pain and flatulence, in the absence of active inflammation. These symptoms are less likely to respond to the common anti-inflammatory drugs and it is important to recognize them, in order to avoid inappropriate therapy and improve QoL. In effect, the cause of these symptoms is related to altered function of the gut and the enteric nervous system, rather than to the inflammatory activity of disease. In these patients, carbohydrate malabsorption has been considered a candidate mechanism by which the diet can induce gut symptoms: lactose and fructose malabsorption has been recognized as a potential cause of symptoms due to the high osmotic activity and fermentability of malabsorbed lactose.
The management of this condition could benefit of a dietary intervention, but data regarding the effect of a low FODMAPs diet in IBD are limited.
Also in coeliac patients, despite a lifelong GFD, some abdominal symptoms such as flatulence, bloating, diarrhea and abdominal pain can persist. However data regarding the effect of a low FODMAPs diet in these subjects are still scarce.
On the basis of these considerations, the aim of this study was to evaluate the clinical impact of a low FODMAPs diet in patients with IBS, CD on GFD and IBD in remission.
Each subject who respected the inclusion criteria was enrolled in the study and was submitted to a diet low in FODMAPs content, after filling out questionnaires on quality of life and symptoms (IBS-SSS and SF-36) (T0).
The IBS-SSS questionnaire consists of 5 questions on: the severity and frequency of abdominal pain, the severity of the bloating, the level of satisfaction in bowel habits and quality of life. Patients give an estimate from 0 to 100 and the results of each question are summed to obtain the final score (theoretical range of 0-500, with a higher score indicating worse condition). Previous studies have established that scores below 175 represents mild IBS symptoms, 175-300 represents moderate severity, and scores above 300 represent severe IBS.
The SF-36 is a questionnaire on the patient's state of health consisting of 36 questions related to eight health domains: AF-physical activity (10 questions), RP-role limitations due to physical health (4 questions) and RE-role limitations due to emotional problems (3 questions), BP-physical pain (2 questions), GH-perception of general health (5 questions), VT-vitality (4 questions), SF-social activities (2 questions), MH-mental health (5 questions) and a single question about the change in health status. All SF-36 questions, except one, are referred to a previous four-week period of the compilation of questionnaire. The eight-scaled scores are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight: the lower the score the more disability; the higher the score the less disability.
After the administration of the questionnaires and the collection of anthropometric measurements (weight and height), patients were put on a low FODMAPs diet (T0). Each regimen was specific for the patient's energy requirement (calculated by BMI) and for its content in FODMAPs, realized in conformity with the food reference tables. This low FODMAPs diet was prescribed by a dietitian for 12 weeks and patients were instructed to eat according to their appetite, received a summary diagram with substances to be taken and those to be avoided and were educated to interpret food labels/ingredients lists.
In order to cover the needs of micro and macronutrients, the administered dietary patterns maintained the contents of oligosaccharides, fructose and polyols not more than 0.5 g.
The questionnaires and the clinical evaluation of the patients were repeated one month (T1) and three months (T3) after the beginning of the diet.
- Being tested
- low FODMAPs diet
- Keywords
- low FODMAPs diet, Adherence, Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Coeliac Disease
- Medical subject headings
- Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low FODMAPs dietDietary supplement
Low FODMAPs diet was a diet containing low amount of poorly absorbed short-chain carbohydrates (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols)
| Study group | Role | What they receive |
|---|---|---|
| IBD patients | Active comparator | All subjects with Crohn's disease in clinical remission (defined in the presence of a Crohn's Disease Activity Index, CDAI <150), and with Ulcerative colitis in clinical remission (defined in the presence of <3 evacuations / day without blood, in the absence of endoscopic alterations) received a low FODMAPs diet.
The low FODMAPs diet was administered for 3 months. Receives: Dietary Supplement: low FODMAPs diet |
| Coeliac patients | Active comparator | Celiac patients on a gluten free diet for at least one year received a low FODMAPs diet. The low FODMAPs diet was administered for 3 months. Receives: Dietary Supplement: low FODMAPs diet |
| IBS patients | Active comparator | Patients with Irritable Bowel Syndrome received a low FODMAPs diet. The low FODMAPs diet was administered for 3 months. Receives: Dietary Supplement: low FODMAPs diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of IBS-SSS after 3 months
to evaluate the clinical impact of a low FODMAPs diet in patients with IBS, CD on GFD and IBD in remission. Each subject who respected the inclusion criteria was enrolled in the study and was submitted to a diet low in FODMAPs content, after filling out questionnaire on quality of life and symptoms (IBS-SSS).
The questionnaire was re-administered after 1 month and 3 months of low FODMAPs diet.
Measured: 1 month and 3 months
Secondary outcomes (1)
Improvement of SF-36 after 3 months
to evaluate the clinical impact of a low FODMAPs diet in patients with IBS, CD on GFD and IBD in remission. Each subject who respected the inclusion criteria was enrolled in the study and was submitted to a diet low in FODMAPs content, after filling out questionnaire on quality of life and symptoms (SF-36).
The questionnaire was re-administered after 1 month and 3 months of low FODMAPs diet.
Measured: 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study startJul 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Federico II 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabiana Castiglione, Federico II University
- Investigators
- Fabiana Castiglione, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644602
- Sponsor's protocol ID
- 285/16
- Acronym
- FODMAPs
- Status last verified
- Aug 2018
- First submitted
- 4 Jul 2017
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of a Low FODMAPs Diet in Different Gastrointestinal Disorders
- ClinicalTrials.gov ID
- NCT03644602
- Acronym / sponsor ID
- FODMAPs / 285/16
- Keywords
- low FODMAPs diet, Adherence, Inflammatory Bowel Diseases, Irritable Bowel Syndrome, Coeliac Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Aug 2018 (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.
Recent studies have shown that FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) free diet is efficient in subjects with Irritable Bowel Syndrome (IBS). Patients with Inflammatory Bowel Diseases (IBD) and celiac disease (CD) can experience functional gastrointestinal symptoms not related to inflammation, but data about the use of low FODMAPs diet in these settings are still scarce. The aim of the present study was to evaluate the usefulness of a low FODMAPs diet in patients with IBS, non-active IBD and CD on strict gluten-free diet (GFD). A low FODMAPs diet could be a valid option to contrast abdominal symptoms in patients with IBS, non-active IBD and CD on GFD, thus improving the quality of life and the social relations.
Detailed description
Recurrent gastrointestinal symptoms (bloating, constipation, abdominal pain, diarrhea and flatulence) often interfere with patients' quality of life (QoL) and daily activities. These symptoms have been noted in various diseases such as irritable bowel syndrome (IBS), celiac disease (CD) and inflammatory bowel diseases (IBD). IBS is the most common diagnosis made by gastroenterologists and affects up to 15% of the population. About 60% of patients with IBS claims that certain foods can exacerbate their symptoms, so pharmacological treatment is often accompanied by dietary measures. Very recently, a diet for the management of functional symptoms associated with IBS has been developed: the low FODMAPs diet. FODMAPs (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) is a collective term that indicates a family of poorly absorbed short-chain carbohydrates. The low FODMAPs diet is a relatively novel area of interest and the majority of studies have been performed in patients with IBS; most of them showed that limiting FODMAPs led to an improvement of intestinal symptoms. Patients with Crohn's disease (CrD) and ulcerative colitis (UC) often experience symptoms related to concomitant functional disease, such as bloating, abdominal pain and flatulence, in the absence of active inflammation. These symptoms are less likely to respond to the common anti-inflammatory drugs and it is important to recognize them, in order to avoid inappropriate therapy and improve QoL. In effect, the cause of these symptoms is related to altered function of the gut and the enteric nervous system, rather than to the inflammatory activity of disease. In these patients, carbohydrate malabsorption has been considered a candidate mechanism by which the diet can induce gut symptoms: lactose and fructose malabsorption has been recognized as a potential cause of symptoms due to the high osmotic activity and fermentability of malabsorbed lactose.
The management of this condition could benefit of a dietary intervention, but data regarding the effect of a low FODMAPs diet in IBD are limited.
Also in coeliac patients, despite a lifelong GFD, some abdominal symptoms such as flatulence, bloating, diarrhea and abdominal pain can persist. However data regarding the effect of a low FODMAPs diet in these subjects are still scarce.
On the basis of these considerations, the aim of this study was to evaluate the clinical impact of a low FODMAPs diet in patients with IBS, CD on GFD and IBD in remission.
Each subject who respected the inclusion criteria was enrolled in the study and was submitted to a diet low in FODMAPs content, after filling out questionnaires on quality of life and symptoms (IBS-SSS and SF-36) (T0).
The IBS-SSS questionnaire consists of 5 questions on: the severity and frequency of abdominal pain, the severity of the bloating, the level of satisfaction in bowel habits and quality of life. Patients give an estimate from 0 to 100 and the results of each question are summed to obtain the final score (theoretical range of 0-500, with a higher score indicating worse condition). Previous studies have established that scores below 175 represents mild IBS symptoms, 175-300 represents moderate severity, and scores above 300 represent severe IBS.
The SF-36 is a questionnaire on the patient's state of health consisting of 36 questions related to eight health domains: AF-physical activity (10 questions), RP-role limitations due to physical health (4 questions) and RE-role limitations due to emotional problems (3 questions), BP-physical pain (2 questions), GH-perception of general health (5 questions), VT-vitality (4 questions), SF-social activities (2 questions), MH-mental health (5 questions) and a single question about the change in health status. All SF-36 questions, except one, are referred to a previous four-week period of the compilation of questionnaire. The eight-scaled scores are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight: the lower the score the more disability; the higher the score the less disability.
After the administration of the questionnaires and the collection of anthropometric measurements (weight and height), patients were put on a low FODMAPs diet (T0). Each regimen was specific for the patient's energy requirement (calculated by BMI) and for its content in FODMAPs, realized in conformity with the food reference tables. This low FODMAPs diet was prescribed by a dietitian for 12 weeks and patients were instructed to eat according to their appetite, received a summary diagram with substances to be taken and those to be avoided and were educated to interpret food labels/ingredients lists.
In order to cover the needs of micro and macronutrients, the administered dietary patterns maintained the contents of oligosaccharides, fructose and polyols not more than 0.5 g.
The questionnaires and the clinical evaluation of the patients were repeated one month (T1) and three months (T3) after the beginning of the diet.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBD patients | Active comparator | Dietary Supplement: low FODMAPs dietAll subjects with Crohn's disease in clinical remission (defined in the presence of a Crohn's Disease Activity Index, CDAI <150), and with Ulcerative colitis in clinical remission (defined in the presence of <3 evacuations / day without blood, in the absence of endoscopic alterations) received a low FODMAPs diet. The low FODMAPs diet was administered for 3 months. |
| Coeliac patients | Active comparator | Dietary Supplement: low FODMAPs dietCeliac patients on a gluten free diet for at least one year received a low FODMAPs diet. The low FODMAPs diet was administered for 3 months. |
| IBS patients | Active comparator | Dietary Supplement: low FODMAPs dietPatients with Irritable Bowel Syndrome received a low FODMAPs diet. The low FODMAPs diet was administered for 3 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- IBS patients
- IBD patients in remission
- Coeliac patients on gluten free diet
Key exclusion criteria (2 listed)
- Active IBD
- Coeliac patients non compliant to gluten free diet
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 FODMAPs dietLow FODMAPs diet was a diet containing low amount of poorly absorbed short-chain carbohydrates (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) | Dietary supplement | Coeliac patients, IBD patients, IBS patients |
Primary outcome
Improvement of IBS-SSS after 3 months
Time frame: 1 month and 3 months
to evaluate the clinical impact of a low FODMAPs diet in patients with IBS, CD on GFD and IBD in remission. Each subject who respected the inclusion criteria was enrolled in the study and was submitted to a diet low in FODMAPs content, after filling out questionnaire on quality of life and symptoms (IBS-SSS). The questionnaire was re-administered after 1 month and 3 months of low FODMAPs diet.
1 secondary outcome
Improvement of SF-36 after 3 months
Time frame: 1 month and 3 months
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 23 Aug 2018.
- 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.
Fabiana Castiglione principal investigator
Federico II 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 FODMAPs diet in people with Inflammatory Bowel Diseases and Irritable Bowel Syndrome, run by Federico II University at 1 site in Italy.
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 3 inclusion and 2 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 23 Aug 2018. 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 Italy. 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?
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 IBS-SSS after 3 months (time frame: 1 month and 3 months). 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 23 Aug 2018.