Irritable Bowel SyndromeNCT05646186
Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome
A study testing Personalized dietary intervention based on microbiome analysis and Low-FODMAP diet in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome With Diarrhea, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
irritable bowel syndrome (IBS) is a well-known risk factor for diseases of the anal region (hemorrhoids, anal fissures, etc.) and large intestine (colon cancer, diverticular disease). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation
- What is being tested?
- Personalized dietary intervention based on microbiome analysis and Low-FODMAP diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 31 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be between the ages of 18-65
- To be diagnosed with IBS (IBS-D, IBS-C, IBS-M) according to the Rome IV Criteria
- To give consent to participate in the study voluntarily
- Being a smartphone and/or internet user (for dietitian follow-up and clinical follow-up)
- Not meeting any of the exclusion criteria
Who cannot join
- Pregnant or planning to become pregnant
- Having another known diagnosis of gastrointestinal disease (inflammatory bowel disease, malabsorption of any macronutrient, intestinal resection, celiac disease, etc.)
- Colonoscopy history (in the last 1 year)
- History of abdominal surgery other than appendectomy or hysterectomy
- Psychiatric comorbidity
- Chronic diseases that will affect the microbiome (cancer, diabetes, cardiovascular disease, liver diseases, neurological diseases, etc.)
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- Use of drugs that may affect digestive function in the 4 weeks prior to the study (antibiotics (including use in the last 4 weeks), probiotics, narcotic analgesics, lactulose (prebiotics))
- Patients taking dietary supplements
- Excluded from the study if following a restricted diet.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medipol University Bahcelievler Hospital
Istanbul, 34196
Osman Civil, MD, +905058334286, dr.ocivil@hotmail.com
Naciye Cigdem Arslan, MD
About this study
Official title: Comparison of Personalized Diet Implementation Based on Microbiome Analysis and FODMAP Diet Efficacy in Irritable Bowel Syndrome
irritable bowel syndrome (IBS) is a well-known risk factor for diseases of the anal region (hemorrhoids, anal fissures, etc.) and large intestine (colon cancer, diverticular disease). Untreatable IBS disease not only impairs the patient's quality of life but also reduces the success of surgical treatment in these diseases.
Today, only one-third of IBS patients achieve successful results with the treatment methods and diets used routinely. Balancing the composition of the gut microbiota may yield satisfactory results in this patient group. With the results of our study, we aim to reveal the effect of microbiome analysis and personalized diet on symptoms and its place in treatment in patients with IBS disease.
Patients applying to Gastroenterology outpatient clinics in respective centers due to IBS will be randomized into two groups. The patients in the control group will follow the FODMAP diet protocol for IBS; In the study group, a personalized diet will be applied according to the gut microbiota. No nutritional supplements will be used in either group. Changes in defecation habits and quality of life scale of both groups will be evaluated at the end of 6 weeks and the results will be compared.
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome Mixed
- Being tested
- Personalized dietary intervention based on microbiome analysis, Low-FODMAP diet
- Keywords
- Microbiome, Microbiota, Personalised medicine, Artificial intelligence
- 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.
Personalized dietary intervention based on microbiome analysisDietary supplement
Also called Enbiosis IBS Scheme
Personalized dietary intervention based on individual microbiome analysis
Low-FODMAP dietDietary supplement
Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet
| Study group | Role | What they receive |
|---|---|---|
| Personalised diet based on microbiome analysis | Experimental | Personalized diet application based on artificial intelligence-assisted microbiome analysis. After the microbiome analysis is made from the stool samples to be taken from the individuals, a personalized diet program will be created with an artificial intelligence-based algorithm and a diet will be applied for 6 weeks with the support of a professional dietitian. Receives: Dietary Supplement: Personalized dietary intervention based on microbiome analysis |
| Low FODMAP diet | Active comparator | After the microbiome analysis is made from the stool samples to be taken from the individuals, low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet will be applied for 6 weeks with the support of a professional dietitian. Receives: Dietary Supplement: Low-FODMAP diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IBS Symptom severity score
Change in IBS Symptom severity score after 6 weeks of dietary intervention
Measured: 6 weeks
Change in IBS quality of life scale
Change in IBS quality of life scale after 6 weeks of dietary intervention
Measured: 6 weeks
Change in Anxiety-depression scale
Change in Anxiety and depression scale after 6 weeks of dietary intervention
Measured: 6 weeks
Secondary outcomes (1)
Difference between study and control arms
A statistically significant difference between study and control groups based on the IBS-SSS, IBS-QOL and Anxiety depression scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Oct 2022
- Primary completion30 Jan 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bozyaka Training and Research Hospital, Tepecik Training and Research Hospital, Dr. Ersin Arslan Education and Training Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646186
- Sponsor's protocol ID
- E-10840098-772.02-5763
- Status last verified
- Sep 2022
- First submitted
- 6 Oct 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data will be made available in a data repository
Publications
Tunali V, Arslan NC, Ermis BH, Dervis Hakim G, Gundogdu A, Hora M, Nalbantoglu OU. A Multicenter Randomized Controlled Trial of Microbiome-Based Artificial Intelligence-Assisted Personalized Diet vs Low-Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols Diet: A Novel Approach for the Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2024 Sep 1;119(9):1901-1912. doi: 10.14309/ajg.0000000000002862. Epub 2024 May 8.
PubMed 38717025
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Personalized Diet Implementation Based on Microbiome Analysis and FODMAP Diet Efficacy in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05646186
- Acronym / sponsor ID
- E-10840098-772.02-5763
- Conditions
- Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome Mixed
- Keywords
- Microbiome, Microbiota, Personalised medicine, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Bozyaka Training and Research Hospital, Tepecik Training and Research Hospital, Dr. Ersin Arslan Education and Training Hospital
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 12 Dec 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.
irritable bowel syndrome (IBS) is a well-known risk factor for diseases of the anal region (hemorrhoids, anal fissures, etc.) and large intestine (colon cancer, diverticular disease). Untreatable IBS disease not only impairs the patient's quality of life but also reduces the success of surgical treatment in these diseases.
Today, only one-third of IBS patients achieve successful results with the treatment methods and diets used routinely. Balancing the composition of the gut microbiota may yield satisfactory results in this patient group. With the results of our study, we aim to reveal the effect of microbiome analysis and personalized diet on symptoms and its place in treatment in patients with IBS disease.
Patients applying to Gastroenterology outpatient clinics in respective centers due to IBS will be randomized into two groups. The patients in the control group will follow the FODMAP diet protocol for IBS; In the study group, a personalized diet will be applied according to the gut microbiota. No nutritional supplements will be used in either group. Changes in defecation habits and quality of life scale of both groups will be evaluated at the end of 6 weeks and the results will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalised diet based on microbiome analysis | Experimental | Dietary Supplement: Personalized dietary intervention based on microbiome analysisPersonalized diet application based on artificial intelligence-assisted microbiome analysis. After the microbiome analysis is made from the stool samples to be taken from the individuals, a personalized diet program will be created with an artificial intelligence-based algorithm and a diet will be applied for 6 weeks with the support of a professional dietitian. |
| Low FODMAP diet | Active comparator | Dietary Supplement: Low-FODMAP dietAfter the microbiome analysis is made from the stool samples to be taken from the individuals, low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet will be applied for 6 weeks with the support of a professional dietitian. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To be between the ages of 18-65
- To be diagnosed with IBS (IBS-D, IBS-C, IBS-M) according to the Rome IV Criteria
- To give consent to participate in the study voluntarily
- Being a smartphone and/or internet user (for dietitian follow-up and clinical follow-up)
- Not meeting any of the exclusion criteria
Key exclusion criteria (9 listed)
- Pregnant or planning to become pregnant
- Having another known diagnosis of gastrointestinal disease (inflammatory bowel disease, malabsorption of any macronutrient, intestinal resection, celiac disease, etc.)
- Colonoscopy history (in the last 1 year)
- History of abdominal surgery other than appendectomy or hysterectomy
- Psychiatric comorbidity
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 |
|---|---|---|
| Personalized dietary intervention based on microbiome analysisAlso: Enbiosis IBS SchemePersonalized dietary intervention based on individual microbiome analysis | Dietary supplement | Personalised diet based on microbiome analysis |
| Low-FODMAP dietLow fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet | Dietary supplement | Low FODMAP diet |
Primary outcome
Change in IBS Symptom severity score
Time frame: 6 weeks
Change in IBS Symptom severity score after 6 weeks of dietary intervention
Change in IBS quality of life scale
Time frame: 6 weeks
Change in IBS quality of life scale after 6 weeks of dietary intervention
Change in Anxiety-depression scale
Time frame: 6 weeks
Change in Anxiety and depression scale after 6 weeks of dietary intervention
1 secondary outcome
Difference between study and control arms
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Derived from this study: PubMed 38717025Tunali V, Arslan NC, Ermis BH, Dervis Hakim G, Gundogdu A, Hora M, Nalbantoglu OU. A Multicenter Randomized Controlled Trial of Microbiome-Based Artificial Intelligence-Assisted Personalized Diet vs Low-Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols Diet: A Novel Approach for the Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2024 Sep 1;119(9):1901-1912. doi: 10.14309/ajg.0000000000002862. Epub 2024 May 8.
- Individual participant dataSharing planned: Undecided. Individual participant data will be made available in a data repository
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized dietary intervention based on microbiome analysis and Low-FODMAP diet in people with Irritable Bowel Syndrome and Irritable Bowel Syndrome With Diarrhea, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 9 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 12 Dec 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 Turkey (Türkiye). 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 Varol TUNALI, Dr. (00905556303231, varoltunali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IBS Symptom severity score (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 NCT05646186, which also lists 1 linked publication.
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 12 Dec 2022.