Irritable Bowel SyndromeDIETSINIBSNCT03423069
Low FODMAPs Diet vs. Specific Dietary Advice in Patients With IBS Diarrheal Variant
A study testing Diet low in FODMAPs and Specific dietary advice for IBS in people with Irritable Bowel Syndrome, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial summary
A reduced content of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) in the diet may be beneficial for patients with IBS diarrheal variant, but so far few randomized trials have reported data in favor of the effective therapeutic superiority of a low-FODMAPs diet compared to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Diet low in FODMAPs and Specific dietary advice for IBS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- 5 Feb 2018to 31 Dec 2020
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rome IV criteria for IBS diarrhea variant (IBS-D).
- Low-lactose diet is allowed, provided that patients agree to keep this intake constant throughout the study period, except in the case of randomization in the treatment arm with a low-FODMAPs diet.
- The use of probiotic products is permitted, and patients who consume probiotic products must be instructed to continue taking the same amount previously taken throughout the study period.
- The drugs used to treat IBS, including antidepressants, will be admitted provided they are used regularly and have a stable dosage for at least one month prior to inclusion in the study.
- Patients must be willing to change their current diet to participate in the study for the whole study period.
Who cannot join
- Serious cardiac, hepatic, neurological or psychiatric diseases.
- GI diseases other than IBS (e.g., inflammatory bowel disease, celiac disease) that could explain current symptoms.
- Patients who previously had a low-content diet of particular substances (for example, low FODMAPs content, vegan diet, gluten-free diet). - This last category of subjects will be able to return to the study provided they suspend the gluten-free diet until thes symptoms reappear.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Diet Low in Fructose, Oligosaccharides, Disaccharides, Monosaccharides, Alcohols and Polyols in Patients With Irritable Bowel Syndrome Diarrheal Variant Respect to Dietary Advice: Randomized, Single Blind Clinical Trial.
A reduced content of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) in the diet may be beneficial for patients with IBS diarrheal variant, but so far few randomized trials have reported data in favor of the effective therapeutic superiority of a low-FODMAPs diet compared to specific IBS dietary advice. On this basis, the present study is aimed, in a multidisciplinary perspective, at investigating possible changes in the symptom profile and intestinal permeability, GI peptides concentrations, metabolic and lipidomic profiles induced by these different diets in patients with IBS diarrheal variant.
Read the detailed description
Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disease (GI) affecting 10% -20% of the population and is composed of abdominal pain/discomfort, in combination with alterations of the stool habit. This is a functional disorder prevalent in Italy with double percentages in urban areas (13.7%) compared to rural ones (5.9%). IBS is still one of the main reasons for patients to seek for gastroenterological advice. The diagnosis of IBS is mainly based on the evaluation of symptom profiles by using different scales of assessment and also taking into account non-GI symptoms (e.g. insomnia, anxiety, and depression), as well as the characteristics of the stools. IBS is classified in different subtypes, namely: IBS diarrheal variant (IBS-D), IBS with constipation (IBS-C), IBS mixed variant (IBS-M) and non-classifiable. The pathophysiology is only partially understood and an abnormal motility, together with alterations in gut-brain communication, a low-grade inflammation, and psychosocial factors, have been variously involved. On the other hand, the therapeutic choices are still scarce. The majority of IBS subjects believe that some foods are responsible for their symptoms, tending to exclude them without, however, compromising their nutritional status [14]. Many dietary approaches have been proposed, but only a few controlled studies have been performed in this field. Recent evidence suggests that the intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) may trigger GI symptoms in patients with IBS. These carbohydrates are poorly absorbed in the small intestine and can pass intact in the colon, where they increase the endoluminal water through the osmotic activity and induce the production of gas due to their fermentation by intestinal bacterial flora. This, in turn, can cause abdominal distension and diarrhea. Data in the literature suggest that a diet with a reduced content in FODMAPs may be beneficial for patients with IBS and diarrhea, but so far few randomized trials have reported data in favor of the effective superiority of a low-FODMAPs diet compared to the specific dietary advice for patients with IBS. On this basis, the present study is aimed at comparing these two diets in a randomized, single-blind clinical trial in IBS patients with diarrhea.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Diet low in FODMAPs, Specific dietary advice for IBS
- Keywords
- Irritable bowel syndrome, FODMAPs, Dietary advice, Gastrointestinal symptoms, Intestinal permeability, Gastrointestinal peptides, Microbiome, Lipidomic profile
- 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.
Diet low in FODMAPsDietary supplement
A strict restriction of all high FODMAP foods for the time of observation. All these foods will be identified by appropriate nutritional visits and alternatives will be suggested to ensure the diet is nutritionally adequate.
Specific dietary advice for IBSDietary supplement
Dietary recommendations such as limitation of alcohol, spicy food and fatty foods, caffeine, carbonated drinks; avoidance of chewing gums and sweeteners containing polyols; small and frequent meals; avoidance of stressful conditions and eating slowly.
| Study group | Role | What they receive |
|---|---|---|
| Diet low in FODMAPs | Experimental | Diet low in FODMAPs (diet A) during 12 weeks (with intermediate nutritional checks every 4 weeks) before returning to the final study visit. Receives: Dietary Supplement: Diet low in FODMAPs |
| Specific dietary advice for IBS | Active comparator | Dietary advice for IBS (diet B) during 12 weeks (with intermediate nutritional checks every 4 weeks) before returning to the final study visit. Receives: Dietary Supplement: Specific dietary advice for IBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the total score of the irritable bowel syndrome - severity scoring system (IBS-SSS) questionnaire
IBS-SSS contains 5 specific questions with instructions on how to score them. Each of the five questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) ranges from 0 to a maximum score of 100 using a visual analog scale (VAS), leading to a total possible score of 500.
The primary outcome corresponds to a change in the total score of the IBS-SSS questionnaire at the end of the treatment period compared to baseline, and the proportion of patients who will achieve a difference in the total symptom score of IBS-SSS ≥50 after diet. Such difference is considered a significant clinical improvement.
Measured: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
Secondary outcomes (4)
Change in the score of the single symptom items of the irritable bowel syndrome - severity scoring system (IBS-SSS) questionnaire
IBS-SSS contains 5 specific questions with instructions on how to score them. Each of the five questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) ranges from 0 to a maximum score of 100 using a visual analog scale (VAS). The secondary outcome is the measure of the effects of the dietary interventions on the individual symptom items score of IBS-SSS, as well as on the characteristics of the stool habit through the administration of the diaries.
Measured: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
Change in the intestinal permeabily evaluation
For the evaluation of intestinal permeability, a test solution is prepared with 40 g sucrose (Su), 10 g lactulose (La) and 5 g mannitol (Ma) dissolved in 100 ml of water.
The participants drink the test solution in the morning after an overnight fast and all urine samples are collected for the subsequent 5 h. Urine samples were stored at -80°C until analysis. The detection and measurement of the three sugar probes, Su, La, and Ma, in urine are performed by high-performance anion exchange chromatography coupled with pulsed amperometric detection.
Measured: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
Change in the GI peptide concentrations
To evaluate GI peptide, blood samples are collected in ice chilled tubes containing Aprotinin and EDTA. The separated plasma are stored at -70 °C until assay. Plasma levels of spexin, copeptin, meteorin, somatostatin and serotonin, are measured by enzyme immunoassay technique using commercial kits before and after the dietary interventions
Measured: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
Change in the lipidomic profile.
To evaluate the lipidomic, profile blood samples are collected in vacutainer tubes containing ethylenediaminetetraacetic acid (EDTA). The erythrocytes are separated from the plasma by centrifugation, suspended in pure water, vortexed and subsequently centrifuged to isolate the membrane pellets. Lipid extraction and lipid transesterification to fatty acid methyl esters (FAMEs) are performed using an automated protocol. Phospholipidsare will be trans-esterified to FAMEs by treatment with a potassium hydroxide (KOH)/methyl alcohol (MeOH) solution and are extracted using n-hexane. Fatty acids quantification will be performed by using a gas chromatography equipment. Quantification of fatty acid methyl esters is performed using a mixture of standards. The amount of each fatty acid is calculated before and after the dietary interventions, as a percentage of the total fatty acid content (relative %).
Measured: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start5 Feb 2018
- Primary completion30 Jul 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- 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
- Model description
- Randomized, single blind clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Riezzo, Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Investigators
- Francesco Russo, Principal investigator, National Institute for Digestive Diseases IRCCS " Saverio de Bellis"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423069
- Sponsor's protocol ID
- RC2018B
- Acronym
- DIETSINIBS
- Status last verified
- Mar 2022
- First submitted
- 22 Jan 2018
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
PubMed 22426087Mearin Manrique F. Irritable bowel syndrome (IBS) subtypes: Nothing resembles less an IBS than another IBS. Rev Esp Enferm Dig. 2016 Feb;108(2):57-8. doi: 10.17235/reed.2016.4195/2016.
PubMed 26838485Gonzalez-Castro AM, Martinez C, Salvo-Romero E, Fortea M, Pardo-Camacho C, Perez-Berezo T, Alonso-Cotoner C, Santos J, Vicario M. Mucosal pathobiology and molecular signature of epithelial barrier dysfunction in the small intestine in irritable bowel syndrome. J Gastroenterol Hepatol. 2017 Jan;32(1):53-63. doi: 10.1111/jgh.13417.
PubMed 27087165Mazzawi T, El-Salhy M. Changes in duodenal enteroendocrine cells in patients with irritable bowel syndrome following dietary guidance. Exp Biol Med (Maywood). 2017 Jul;242(13):1355-1362. doi: 10.1177/1535370217699537. Epub 2017 Mar 17.
PubMed 28737477Shepherd SJ, Lomer MC, Gibson PR. Short-chain carbohydrates and functional gastrointestinal disorders. Am J Gastroenterol. 2013 May;108(5):707-17. doi: 10.1038/ajg.2013.96. Epub 2013 Apr 16.
PubMed 23588241Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25.
PubMed 24076059McKee AM, Prior A, Whorwell PJ. Exclusion diets in irritable bowel syndrome: are they worthwhile? J Clin Gastroenterol. 1987 Oct;9(5):526-8. doi: 10.1097/00004836-198710000-00007.
PubMed 3680901Linsalata M, Prospero L, Ignazzi A, Riezzo G, D'Attoma B, Mallardi D, Goscilo F, Notarnicola M, De Nunzio V, Pinto G, Russo F. Depression in Diarrhea-Predominant IBS Patients: Exploring the Link Between Gut Barrier Dysfunction and Erythrocyte Polyunsaturated Fatty Acid Levels. J Clin Med. 2025 Apr 5;14(7):2483. doi: 10.3390/jcm14072483.
PubMed 40217932Prospero L, Riezzo G, Linsalata M, Orlando A, D'Attoma B, Di Masi M, Martulli M, Russo F. Somatization in patients with predominant diarrhoea irritable bowel syndrome: the role of the intestinal barrier function and integrity. BMC Gastroenterol. 2021 May 22;21(1):235. doi: 10.1186/s12876-021-01820-7.
PubMed 34022802
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Diet Low in Fructose, Oligosaccharides, Disaccharides, Monosaccharides, Alcohols and Polyols in Patients With Irritable Bowel Syndrome Diarrheal Variant Respect to Dietary Advice: Randomized, Single Blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT03423069
- Acronym / sponsor ID
- DIETSINIBS / RC2018B
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome, FODMAPs, Dietary advice, Gastrointestinal symptoms, Intestinal permeability, Gastrointestinal peptides, Microbiome, Lipidomic profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Feb 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.
A reduced content of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) in the diet may be beneficial for patients with IBS diarrheal variant, but so far few randomized trials have reported data in favor of the effective therapeutic superiority of a low-FODMAPs diet compared to specific IBS dietary advice. On this basis, the present study is aimed, in a multidisciplinary perspective, at investigating possible changes in the symptom profile and intestinal permeability, GI peptides concentrations, metabolic and lipidomic profiles induced by these different diets in patients with IBS diarrheal variant.
Detailed description
Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disease (GI) affecting 10% -20% of the population and is composed of abdominal pain/discomfort, in combination with alterations of the stool habit. This is a functional disorder prevalent in Italy with double percentages in urban areas (13.7%) compared to rural ones (5.9%). IBS is still one of the main reasons for patients to seek for gastroenterological advice. The diagnosis of IBS is mainly based on the evaluation of symptom profiles by using different scales of assessment and also taking into account non-GI symptoms (e.g. insomnia, anxiety, and depression), as well as the characteristics of the stools. IBS is classified in different subtypes, namely: IBS diarrheal variant (IBS-D), IBS with constipation (IBS-C), IBS mixed variant (IBS-M) and non-classifiable. The pathophysiology is only partially understood and an abnormal motility, together with alterations in gut-brain communication, a low-grade inflammation, and psychosocial factors, have been variously involved. On the other hand, the therapeutic choices are still scarce. The majority of IBS subjects believe that some foods are responsible for their symptoms, tending to exclude them without, however, compromising their nutritional status [14]. Many dietary approaches have been proposed, but only a few controlled studies have been performed in this field. Recent evidence suggests that the intake of fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) may trigger GI symptoms in patients with IBS. These carbohydrates are poorly absorbed in the small intestine and can pass intact in the colon, where they increase the endoluminal water through the osmotic activity and induce the production of gas due to their fermentation by intestinal bacterial flora. This, in turn, can cause abdominal distension and diarrhea. Data in the literature suggest that a diet with a reduced content in FODMAPs may be beneficial for patients with IBS and diarrhea, but so far few randomized trials have reported data in favor of the effective superiority of a low-FODMAPs diet compared to the specific dietary advice for patients with IBS. On this basis, the present study is aimed at comparing these two diets in a randomized, single-blind clinical trial in IBS patients with diarrhea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, single blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Diet low in FODMAPs | Experimental | Dietary Supplement: Diet low in FODMAPsDiet low in FODMAPs (diet A) during 12 weeks (with intermediate nutritional checks every 4 weeks) before returning to the final study visit. |
| Specific dietary advice for IBS | Active comparator | Dietary Supplement: Specific dietary advice for IBSDietary advice for IBS (diet B) during 12 weeks (with intermediate nutritional checks every 4 weeks) before returning to the final study visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Rome IV criteria for IBS diarrhea variant (IBS-D).
- Low-lactose diet is allowed, provided that patients agree to keep this intake constant throughout the study period, except in the case of randomization in the treatment arm with a low-FODMAPs diet.
- The use of probiotic products is permitted, and patients who consume probiotic products must be instructed to continue taking the same amount previously taken throughout the study period.
- The drugs used to treat IBS, including antidepressants, will be admitted provided they are used regularly and have a stable dosage for at least one month prior to inclusion in the study.
- Patients must be willing to change their current diet to participate in the study for the whole study period.
Key exclusion criteria (3 listed)
- Serious cardiac, hepatic, neurological or psychiatric diseases.
- GI diseases other than IBS (e.g., inflammatory bowel disease, celiac disease) that could explain current symptoms.
- Patients who previously had a low-content diet of particular substances (for example, low FODMAPs content, vegan diet, gluten-free diet). - This last category of subjects will be able to return to the study provided they suspend the gluten-free diet until thes symptoms reappear.
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 |
|---|---|---|
| Diet low in FODMAPsA strict restriction of all high FODMAP foods for the time of observation. All these foods will be identified by appropriate nutritional visits and alternatives will be suggested to ensure the diet is nutritionally adequate. | Dietary supplement | Diet low in FODMAPs |
| Specific dietary advice for IBSDietary recommendations such as limitation of alcohol, spicy food and fatty foods, caffeine, carbonated drinks; avoidance of chewing gums and sweeteners containing polyols; small and frequent meals; avoidance of stressful conditions and eating slowly. | Dietary supplement | Specific dietary advice for IBS |
Primary outcome
Change in the total score of the irritable bowel syndrome - severity scoring system (IBS-SSS) questionnaire
Time frame: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
IBS-SSS contains 5 specific questions with instructions on how to score them. Each of the five questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) ranges from 0 to a maximum score of 100 using a visual analog scale (VAS), leading to a total possible score of 500. The primary outcome corresponds to a change in the total score of the IBS-SSS questionnaire at the end of the treatment period compared to baseline, and the proportion of patients who will achieve a difference in the total symptom score of IBS-SSS ≥50 after diet. Such difference is considered a significant clinical improvement.
4 secondary outcomes
Change in the score of the single symptom items of the irritable bowel syndrome - severity scoring system (IBS-SSS) questionnaire
Time frame: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
Change in the intestinal permeabily evaluation
Time frame: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
Change in the GI peptide concentrations
Time frame: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
Change in the lipidomic profile.
Time frame: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).
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 22 Mar 2022.
- Background: PubMed 22426087Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012 Jul;10(7):712-721.e4. doi: 10.1016/j.cgh.2012.02.029. Epub 2012 Mar 15.
- Background: PubMed 26838485Mearin Manrique F. Irritable bowel syndrome (IBS) subtypes: Nothing resembles less an IBS than another IBS. Rev Esp Enferm Dig. 2016 Feb;108(2):57-8. doi: 10.17235/reed.2016.4195/2016.
- Background: PubMed 27087165Gonzalez-Castro AM, Martinez C, Salvo-Romero E, Fortea M, Pardo-Camacho C, Perez-Berezo T, Alonso-Cotoner C, Santos J, Vicario M. Mucosal pathobiology and molecular signature of epithelial barrier dysfunction in the small intestine in irritable bowel syndrome. J Gastroenterol Hepatol. 2017 Jan;32(1):53-63. doi: 10.1111/jgh.13417.
- Background: PubMed 28737477Mazzawi T, El-Salhy M. Changes in duodenal enteroendocrine cells in patients with irritable bowel syndrome following dietary guidance. Exp Biol Med (Maywood). 2017 Jul;242(13):1355-1362. doi: 10.1177/1535370217699537. Epub 2017 Mar 17.
- Background: PubMed 23588241Shepherd SJ, Lomer MC, Gibson PR. Short-chain carbohydrates and functional gastrointestinal disorders. Am J Gastroenterol. 2013 May;108(5):707-17. doi: 10.1038/ajg.2013.96. Epub 2013 Apr 16.
- Background: PubMed 24076059Halmos EP, Power VA, Shepherd SJ, Gibson PR, Muir JG. A diet low in FODMAPs reduces symptoms of irritable bowel syndrome. Gastroenterology. 2014 Jan;146(1):67-75.e5. doi: 10.1053/j.gastro.2013.09.046. Epub 2013 Sep 25.
- Background: PubMed 3680901McKee AM, Prior A, Whorwell PJ. Exclusion diets in irritable bowel syndrome: are they worthwhile? J Clin Gastroenterol. 1987 Oct;9(5):526-8. doi: 10.1097/00004836-198710000-00007.
- Derived from this study: PubMed 40217932Linsalata M, Prospero L, Ignazzi A, Riezzo G, D'Attoma B, Mallardi D, Goscilo F, Notarnicola M, De Nunzio V, Pinto G, Russo F. Depression in Diarrhea-Predominant IBS Patients: Exploring the Link Between Gut Barrier Dysfunction and Erythrocyte Polyunsaturated Fatty Acid Levels. J Clin Med. 2025 Apr 5;14(7):2483. doi: 10.3390/jcm14072483.
- Derived from this study: PubMed 34022802Prospero L, Riezzo G, Linsalata M, Orlando A, D'Attoma B, Di Masi M, Martulli M, Russo F. Somatization in patients with predominant diarrhoea irritable bowel syndrome: the role of the intestinal barrier function and integrity. BMC Gastroenterol. 2021 May 22;21(1):235. doi: 10.1186/s12876-021-01820-7.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Francesco Russo principal investigator
National Institute for Digestive Diseases IRCCS " Saverio de Bellis"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet low in FODMAPs and Specific dietary advice for IBS in people with Irritable Bowel Syndrome, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis 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 5 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: finished, as of the sponsor's last update on 22 Mar 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 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?
Change in the total score of the irritable bowel syndrome - severity scoring system (IBS-SSS) questionnaire (time frame: Time frame: Before the start of the study (time 0) and after 90 days of treatment (time 90).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03423069, which also lists 9 linked publications.
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 22 Mar 2022.