IBS - Irritable Bowel SyndromeNCT05192603
Comparison Between Low FODMAP and SSRD in IBS
A study testing low FODMAP or SSRD in people with IBS - Irritable Bowel Syndrome, run by Region Skane at 1 site in Sweden.
Trial summary
The aim of the present study is to compare the efficiency of low FODMAP and SSRD to reduce symptoms in IBS, and to study the mechanisms and consequences of the two diets. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- low FODMAP or SSRD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2022to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Verified IBS according to Rom IV criteria.
Who cannot join
- Serious mental disease
- Serious somatic disease
- Abuse
- Inability to understand the Swedish language
- Already on a diet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison in the Effects and Mechanisms Between Low Fermentable-, Oligo-, di-, and Monosaccharides and Polyols (FODMAP) and Starch- and Sucrose-reduced Diet (SSRD) in Irritable Bowel Syndrome (IBS)
The aim of the present study is to compare the efficiency of low FODMAP and SSRD to reduce symptoms in IBS, and to study the mechanisms and consequences of the two diets.
Read the detailed description
The investigator will perform a study on 200 subjects with verified irritable bowel syndrome (IBS). Participants will be recruited from the clinic of Gastroenterology or Internal medicine as well as primary health care centers. At the start of the study, participants will complete protocols concerning Rom IV criteria (to validate that the IBS criteria are ful-filled) as well as IBS symptom rating scales irritable bowel syndrome-symptoms severity scores (IBS-SSS) and visual analog scale for irritable bowel syndrome (VAS-IBS). The Item Health Survey 1.0 (distributed by RAND), RAND-36, includes the same items as those in the Short-Form Health Survey (SF-36), and evaluates the quality of Life. SCOFF is a brief questionnaire that asks the five questions about eating disturbances (Do you make yourself Sick because you feel uncomfortably full? Do you worry you have lost Control over how much you eat? Have you recently lost more than One stone in a 3 month period? Do you believe yourself to be Fat when others say you are too thin? Would you say that Food dominates your life?). Participants will be examined by an investigator who will complete protocols of clinical data. Blood and fecal samples will be collected by the investigator.
Study participants will thereafter be randomized to receive either low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=100), or a SSRD diet (starch ans sucrose-reduced diet) (n=100). After 4 weeks of dietary intervention, there will be a follow-up where blood and fecal samples are once again collected. At this point in time, participants will also fill in IBS symptom rating scales again.
The participants are then free to eat whatever they want to, and another 5 months later, they will be examined again, the same protocols will be completed, and blood and fecal samples are collected.
The investigator will use samples from baseline, 4 weeks and 6 months, for genetic/epigenetic (including genomic-wide association studies), metabolomics, proteomics, nutritional data, gut microbiota, and inflammatory parameter analyses.
Statistics
The investigator will use Mann-Whitney U-test and Wilcoxon test to study differences in the above-mentioned parameters between the two treatment groups, as well as before and after dietary intervention, respectively. For analyses of genetic/epigenetics, metabolomics, proteomics, and microbiota, the investigator will use bioinformatics and biostatistics.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- low FODMAP or SSRD
- Keywords
- IBS, low FODMAP, SSRD
- 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 or SSRDDietary supplement
The participants are given oral and written information about each diet. No food is delivered from the investigator to the participant
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention with Low FODMAP | Experimental | The participants are given oral and written instructions on which diet that contains low contents of FODMAP. Receives: Dietary Supplement: low FODMAP or SSRD |
| Dietary intervention with SSRD | Experimental | The participants are given oral and written instructions on which diet that contains SSRD. Receives: Dietary Supplement: low FODMAP or SSRD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency on bowel and extra-intestinal symptoms
To assess bowel symptoms and extra-intestinal symptoms after the dietary interventions by evaluation of irritable bowel syndrome-symptom severity score (IBS-SSS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Measured: 4 weeks dietary intervention
Efficiency on bowel and extra-intestinal symptoms
To assess bowel symptoms and extra-intestinal symptoms after the dietary interventions by evaluation of IBS-SSS. This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Measured: A follow-up 5 months after the end of the intervention
Efficiency on bowel symptoms
To assess bowel symptoms after the dietary interventions by evaluation of visual analog scale for irritable bowel syndrome (VAS-IBS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Measured: 4 weeks dietary intervention
Efficiency on bowel symptoms
To assess bowel symptoms after the dietary interventions by evaluation of visual analog scale for irritable bowel syndrome (VAS-IBS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Measured: A follow-up 5 months after the end of the intervention
Secondary outcomes (23)
Effects on plasminogen activator inhibitor-1 (PAI-1)
The investigator will analyze plasminogen activator inhibitor-1 (PAI-1) by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on C-peptide
The investigator will analyze C-peptide by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on insulin
The investigator will analyze insulin by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on leptin
The investigator will analyze leptin by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on gastric inhibitory peptide (GIP)
The investigator will analyze GIP by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on visfatin
The investigator will analyze visfatin by mesoscale to see and compare the effects of the two different diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on ghrelin
The investigator will analyze ghrelin by mesoscale to see and compare the effects of the two different diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on gut microbiota by whole genome sequencing of feces
The investigator will analyze fecal microbiota by whole genome sequencing to see and compare the effects of the two different diets
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on microRNA
The investigator will analyze microRNA to see and compare the effects of the two different diets
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on DNA methylation
The investigator will analyze DNA methylation to see and compare the effects of the two different diets
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects depending on genetics
The investigator will analyze sucrase-isomaltase (SI) genes to see if the genetic profile hais of importance for the clinical effect of the two diets
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on vitamin A
The investigator will analyze values of vitamin A in blood before and after the study to compare the effects on the nutritional status by the two diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on vitamin B
The investigator will analyze values of vitamin B in blood before and after the study to compare the effects on the nutritional status by the two diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on vitamin C
The investigator will analyze values of vitamin C in blood before and after the study to compare the effects on the nutritional status by the two diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on vitamin D
The investigator will analyze values of vitamin D in blood before and after the study to compare the effects on the nutritional status by the two diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on phosphorous
The investigator will analyze values of phosphorous in blood before and after the study to compare the effects on the nutritional status by the two diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on zinc
The investigator will analyze values of zinc in blood before and after the study to compare the effects on the nutritional status by the two diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on magnesium
The investigator will analyze values of magnesium in blood before and after the study to compare the effects on the nutritional status by the two diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on albumin
The investigator will analyze values of albumin in blood before and after the study to compare the effects on the nutritional status by the two diets.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on metabolomics and proteomics
The investigator will analyze metabolomics and proteomics in blood to see and compare the effects of the two different diets
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on quality of life by RAND-36 (comprehensive short-form generic profile for health-related quality of life (HRQoL))
The investigator will analyze how the two different diets influence quality of life, measured by RAND-36, to compare the effects of the two different diets. RAND-36 is comprised of 36 items on 5-point Likert scale, the higher score the better quality of life, that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on eating disturbances
The investigator will analyze how the two different diets influence eating disturbances measured by SCOFF, to compare the effects of the two different diets. SCOFF contains 5 questions answered by "yes" or "no": 1) Do you make yourself Sick because you feel uncomfortably full?, 2) Do you worry that you have lost Control over how much you eat?, 3)Have you recently lost more than One stone (14 lb) in a 3-month period?, 4)Do you believe yourself to be Fat when others say you are too thin?, and 5) Would you say that Food dominates your life?
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on healthcare consumption
The investigator will analyze how the two different diets influence healthcare consumption by asking the participants about how many times they have visited a Healthcare giver before, during and after the study, to compare the effects of the two different diets
Measured: 4 weeks dietary intervention, with a follow-up after another 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Mar 2022
- Primary completion13 Feb 2024
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Parallel groups
- Model description
- Randomized, open study for dietary intervention
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bodil Ohlsson, Region Skane
- Investigators
- Bodil Ohlsson, Professor, Principal investigator, Department of Internal MedicineBodil Roth, PhD, Study chair, Department of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192603
- Sponsor's protocol ID
- IBS-2021
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2021
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roth B, Ohlsson B. Overweight and vitamin D deficiency are common in patients with irritable bowel syndrome - a cross-sectional study. BMC Gastroenterol. 2024 Sep 3;24(1):296. doi: 10.1186/s12876-024-03373-x.
PubMed 39227769Roth B, Ohlsson B. Challenges of recruitment processes to a randomized dietary trial in irritable bowel syndrome. F1000Res. 2024 Jun 24;13:323. doi: 10.12688/f1000research.147710.2. eCollection 2024.
PubMed 38939366Roth B, Ohlsson B. A starch- and sucrose-reduced diet may lead to improvement of intestinal and extraintestinal symptoms in more conditions than irritable bowel syndrome and congenital sucrase-isomaltase deficiency. Nutrition. 2024 Jan;117:112254. doi: 10.1016/j.nut.2023.112254. Epub 2023 Oct 8.
PubMed 37924624
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison in the Effects and Mechanisms Between Low Fermentable-, Oligo-, di-, and Monosaccharides and Polyols (FODMAP) and Starch- and Sucrose-reduced Diet (SSRD) in Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT05192603
- Acronym / sponsor ID
- IBS-2021
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- IBS, low FODMAP, SSRD
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 14 Jan 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.
The aim of the present study is to compare the efficiency of low FODMAP and SSRD to reduce symptoms in IBS, and to study the mechanisms and consequences of the two diets.
Detailed description
The investigator will perform a study on 200 subjects with verified irritable bowel syndrome (IBS). Participants will be recruited from the clinic of Gastroenterology or Internal medicine as well as primary health care centers. At the start of the study, participants will complete protocols concerning Rom IV criteria (to validate that the IBS criteria are ful-filled) as well as IBS symptom rating scales irritable bowel syndrome-symptoms severity scores (IBS-SSS) and visual analog scale for irritable bowel syndrome (VAS-IBS). The Item Health Survey 1.0 (distributed by RAND), RAND-36, includes the same items as those in the Short-Form Health Survey (SF-36), and evaluates the quality of Life. SCOFF is a brief questionnaire that asks the five questions about eating disturbances (Do you make yourself Sick because you feel uncomfortably full? Do you worry you have lost Control over how much you eat? Have you recently lost more than One stone in a 3 month period? Do you believe yourself to be Fat when others say you are too thin? Would you say that Food dominates your life?). Participants will be examined by an investigator who will complete protocols of clinical data. Blood and fecal samples will be collected by the investigator.
Study participants will thereafter be randomized to receive either low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=100), or a SSRD diet (starch ans sucrose-reduced diet) (n=100). After 4 weeks of dietary intervention, there will be a follow-up where blood and fecal samples are once again collected. At this point in time, participants will also fill in IBS symptom rating scales again.
The participants are then free to eat whatever they want to, and another 5 months later, they will be examined again, the same protocols will be completed, and blood and fecal samples are collected.
The investigator will use samples from baseline, 4 weeks and 6 months, for genetic/epigenetic (including genomic-wide association studies), metabolomics, proteomics, nutritional data, gut microbiota, and inflammatory parameter analyses.
Statistics
The investigator will use Mann-Whitney U-test and Wilcoxon test to study differences in the above-mentioned parameters between the two treatment groups, as well as before and after dietary intervention, respectively. For analyses of genetic/epigenetics, metabolomics, proteomics, and microbiota, the investigator will use bioinformatics and biostatistics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open study for dietary intervention
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention with Low FODMAP | Experimental | Dietary Supplement: low FODMAP or SSRDThe participants are given oral and written instructions on which diet that contains low contents of FODMAP. |
| Dietary intervention with SSRD | Experimental | Dietary Supplement: low FODMAP or SSRDThe participants are given oral and written instructions on which diet that contains SSRD. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Verified IBS according to Rom IV criteria.
Key exclusion criteria (5 listed)
- Serious mental disease
- Serious somatic disease
- Abuse
- Inability to understand the Swedish language
- Already on a 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 FODMAP or SSRDThe participants are given oral and written information about each diet. No food is delivered from the investigator to the participant | Dietary supplement | Dietary intervention with Low FODMAP, Dietary intervention with SSRD |
Primary outcome
Efficiency on bowel and extra-intestinal symptoms
Time frame: 4 weeks dietary intervention
To assess bowel symptoms and extra-intestinal symptoms after the dietary interventions by evaluation of irritable bowel syndrome-symptom severity score (IBS-SSS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Efficiency on bowel and extra-intestinal symptoms
Time frame: A follow-up 5 months after the end of the intervention
To assess bowel symptoms and extra-intestinal symptoms after the dietary interventions by evaluation of IBS-SSS. This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Efficiency on bowel symptoms
Time frame: 4 weeks dietary intervention
To assess bowel symptoms after the dietary interventions by evaluation of visual analog scale for irritable bowel syndrome (VAS-IBS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Efficiency on bowel symptoms
Time frame: A follow-up 5 months after the end of the intervention
To assess bowel symptoms after the dietary interventions by evaluation of visual analog scale for irritable bowel syndrome (VAS-IBS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
23 secondary outcomes
Effects on plasminogen activator inhibitor-1 (PAI-1)
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on C-peptide
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on insulin
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on leptin
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on gastric inhibitory peptide (GIP)
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on visfatin
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on ghrelin
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on gut microbiota by whole genome sequencing of feces
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on microRNA
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on DNA methylation
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects depending on genetics
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on vitamin A
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on vitamin B
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on vitamin C
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on vitamin D
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on phosphorous
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on zinc
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on magnesium
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on albumin
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on metabolomics and proteomics
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on quality of life by RAND-36 (comprehensive short-form generic profile for health-related quality of life (HRQoL))
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on eating disturbances
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Effects on healthcare consumption
Time frame: 4 weeks dietary intervention, with a follow-up after another 5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Derived from this study: PubMed 39227769Roth B, Ohlsson B. Overweight and vitamin D deficiency are common in patients with irritable bowel syndrome - a cross-sectional study. BMC Gastroenterol. 2024 Sep 3;24(1):296. doi: 10.1186/s12876-024-03373-x.
- Derived from this study: PubMed 38939366Roth B, Ohlsson B. Challenges of recruitment processes to a randomized dietary trial in irritable bowel syndrome. F1000Res. 2024 Jun 24;13:323. doi: 10.12688/f1000research.147710.2. eCollection 2024.
- Derived from this study: PubMed 37924624Roth B, Ohlsson B. A starch- and sucrose-reduced diet may lead to improvement of intestinal and extraintestinal symptoms in more conditions than irritable bowel syndrome and congenital sucrase-isomaltase deficiency. Nutrition. 2024 Jan;117:112254. doi: 10.1016/j.nut.2023.112254. Epub 2023 Oct 8.
- 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.
Bodil Ohlsson, Professor principal investigator
Department of Internal Medicine
Bodil Roth, PhD study chair
Department of Internal Medicine
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 or SSRD in people with IBS - Irritable Bowel Syndrome, run by Region Skane at 1 site in Sweden.
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 5 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: enrolling by invitation, as of the sponsor's last update on 9 Dec 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Efficiency on bowel and extra-intestinal symptoms (time frame: 4 weeks dietary intervention). The study lists 4 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 NCT05192603, which also lists 3 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 9 Dec 2025; AzTrials last refreshed its copy on 2 Nov 2026.