IBS - Irritable Bowel SyndromeSI IBSNCT07309601
Sucrase-Isomaltase (SI) Genes and Meal Load
A study testing Meal load in people with IBS - Irritable Bowel Syndrome and Sucrase-Isomaltase Deficiency, run by Region Skane at 1 site in Sweden.
Trial summary
The goal of this interventional study is to examine whether those patients with irritable bowel syndrome (IBS) and a reduced abitility do degrade starch and sugar (lowe levels of enzymes) have lower raise in blood glucose after a meal than those with normal expression of enzymes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome, Sucrase-Isomaltase Deficiency
- What is being tested?
- Meal load
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSweden
- Study dates
- 1 Feb 2026to 1 Feb 2030
- 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
- Diagnosis of irritable bowel syndrome (IBS)
- Gene testing has been conducted regarding genes regulating the production of sucrase-isomaltase ensymes in previous dietary interventions using the starch- and sucrose reduced diet (SSRD) or multi-center study.
Who cannot join
- Diagnosis of inflammatory bowel disease, celiac disease, bile salt malabsorption, gastroenteritis or enteric dysmotility
- Severe food allergy
- Serious heart-, lung-, cardiovascular-, malignant- or mental illness
- Ongoing eating disorder
- Pregnancy
- Recent major gastrointestinal surgery
- Alcohol and/or drug addiction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mauro D'Amato Professor contact
Sweden1 site, 1 recruiting
- Recruiting
Skåne University Hospital
Malmö, Skåne County, 20502
Bodil Ohlsson, Professor, MD, PhD, +46402712660, bodil.ohlsson@med.lu.se
Cecilia Kennbäck, Nurse, cecilia.kennback@skane.se
About this study
Official title: Comparison of a Meal Load Between Normal and Functional Variants of the Sucrase-isomaltase (SI) Gene in IBS
The goal of this interventional study is to examine whether those patients with irritable bowel syndrome (IBS) and a reduced abitility do degrade starch and sugar (lowe levels of enzymes) have lower raise in blood glucose after a meal than those with normal expression of enzymes. We also want to examine whether those IBS patients with reduced enzyme levels have increased bowel symptom in relation to this meal.
The main questions it aims to answer are:
Does reduced ability to degrade starch and sugar due to less enzyme activity lead to lower increase in blood glucose after a meal? Does reduced ability to degrade starch and sugar due to less enzyme activity lead to increased bowel symptoms after a meal?
Read the detailed description
All IBS patients who have been included in the previous studies (Dnr 2017/171, Dnr 2021-05407-01 and Dnr 2023-01377-01) and have been genetically tested for the sucrase-isomaltse enzyme (SI gene) and other genes encoding enzymes important for carbohydrate absorption will be called and asked if they want to participate in the present study.
The patient receives a basic questionnaire about lifestyle, health and symptoms over the past 2 weeks, including Rome IV questionnaire, irritable bowel syndrome-severity scoring system (IBS-SSS), and visual analog scale for irritable bowel syndrome (VAS-IBS) to be completed at home and brought to the test. The patient comes to the clinic fasting (only allowed to drink water at home in the morning). A plastic tube is placed in the arm, and the patient has to eat a sugar-rich meal during 15 minutes. Blood samples are drawn 10 minutes before start, at the start of the meal, and 10, 20, 30, 45, 60, 90, och 120 minutes aftrewards. Blood samples are analyzed for glucose levels in blood at the Department of Clinical Chemistry, at the hospital. At the same time points as blood sampling, the patient has to complete a questionnaire about bowel symptoms.
Raise in blood glucose and bowel symptoms will be compared between those with reduced enzyme activity and those with normal enzyme activity. The correlation between blood glucose levels and symptoms will be calculated.
- Being tested
- Meal load
- Keywords
- IBS, SI genes, Starch and sucrose, blood glucose levels, bowel symptoms
- Medical subject headings
- Irritable Bowel Syndrome, Sucrase-isomaltase deficiency, congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal loadDietary supplement
Meal load during 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Meal intake | Experimental | Not described Receives: Dietary Supplement: Meal load |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of blood glucose after a meal intake
We will measure blood glucose levels in plasma through a plastic tube. Two samples will be collected before the meal start. One sample 10 minutes before the meal intake and one immediately prior the meal intake. The meal consists of a sugar-rich breakfast, which must be ingested within 15 minutes. Blood samples will then be collected at 10, 20, 30, 45, 60, 90, and 120 minutes afterwards. Blood glucose will be measured at the Department of Clinical Chemistry at the hospital, according to clinical routines.
Measured: 2 hours
Secondary outcomes (1)
Changes of gastrointestinal and extraintestinal symptoms after a meal intake assesssed by self-reported completion on visual analog scales
The assessment of changes of gastrointestinal and extraintestinal symptoms will be registered during the breakfast meal. The degree of the symptoms abdominal pain; diarrhea; constipation; bloating/flatulence; vomiting/nausea; belching/excess wind; reflux; headache; back pain; muscle/joint pain; and fatigue will be rated by the participants on 100 mm visual analg scales (VAS); one scale for each symptom. 0 mm means no symptoms and 100 means maximal symptoms. The symptoms will be registered at the same tima as the blood samples will be collected. Thus, participants have to register the symptoms 10 minutes before the meal intake, immediately prior the meal intake, and then 10, 20, 30, 45, 60, 90, and 120 minutes afterwards. These VAS scales are extracted from the validated questionnaires the irritable bowel syndrome-severity symptom score (IBS-SSS) and the visual analg scale for irritable bowel syndrome (VAS-IBS).
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Feb 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bodil Ohlsson, Region Skane
- Investigators
- Cecilia Kennbäck, Registered Nurse, Study chair, Department of Internal Medicine, Skåne University Hospital, 20502 Malmö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309601
- Sponsor's protocol ID
- 2025-07563-01
- Other IDs
- 2025
- Acronym
- SI IBS
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical rules in Sweden, we can not share individual data. The participants have written an informed concent that data will be presented group wise.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Meal Load Between Normal and Functional Variants of the Sucrase-isomaltase (SI) Gene in IBS
- ClinicalTrials.gov ID
- NCT07309601
- Acronym / sponsor ID
- SI IBS / 2025-07563-01
- Keywords
- IBS, SI genes, Starch and sucrose, blood glucose levels, bowel symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 30 Dec 2025 (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 goal of this interventional study is to examine whether those patients with irritable bowel syndrome (IBS) and a reduced abitility do degrade starch and sugar (lowe levels of enzymes) have lower raise in blood glucose after a meal than those with normal expression of enzymes. We also want to examine whether those IBS patients with reduced enzyme levels have increased bowel symptom in relation to this meal.
The main questions it aims to answer are:
Does reduced ability to degrade starch and sugar due to less enzyme activity lead to lower increase in blood glucose after a meal? Does reduced ability to degrade starch and sugar due to less enzyme activity lead to increased bowel symptoms after a meal?
Detailed description
All IBS patients who have been included in the previous studies (Dnr 2017/171, Dnr 2021-05407-01 and Dnr 2023-01377-01) and have been genetically tested for the sucrase-isomaltse enzyme (SI gene) and other genes encoding enzymes important for carbohydrate absorption will be called and asked if they want to participate in the present study.
The patient receives a basic questionnaire about lifestyle, health and symptoms over the past 2 weeks, including Rome IV questionnaire, irritable bowel syndrome-severity scoring system (IBS-SSS), and visual analog scale for irritable bowel syndrome (VAS-IBS) to be completed at home and brought to the test. The patient comes to the clinic fasting (only allowed to drink water at home in the morning). A plastic tube is placed in the arm, and the patient has to eat a sugar-rich meal during 15 minutes. Blood samples are drawn 10 minutes before start, at the start of the meal, and 10, 20, 30, 45, 60, 90, och 120 minutes aftrewards. Blood samples are analyzed for glucose levels in blood at the Department of Clinical Chemistry, at the hospital. At the same time points as blood sampling, the patient has to complete a questionnaire about bowel symptoms.
Raise in blood glucose and bowel symptoms will be compared between those with reduced enzyme activity and those with normal enzyme activity. The correlation between blood glucose levels and symptoms will be calculated.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meal intake | Experimental | Dietary Supplement: Meal load |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of irritable bowel syndrome (IBS)
- Gene testing has been conducted regarding genes regulating the production of sucrase-isomaltase ensymes in previous dietary interventions using the starch- and sucrose reduced diet (SSRD) or multi-center study.
Key exclusion criteria (7 listed)
- Diagnosis of inflammatory bowel disease, celiac disease, bile salt malabsorption, gastroenteritis or enteric dysmotility
- Severe food allergy
- Serious heart-, lung-, cardiovascular-, malignant- or mental illness
- Ongoing eating disorder
- Pregnancy
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 |
|---|---|---|
| Meal loadMeal load during 15 minutes | Dietary supplement | Meal intake |
Primary outcome
Changes of blood glucose after a meal intake
Time frame: 2 hours
We will measure blood glucose levels in plasma through a plastic tube. Two samples will be collected before the meal start. One sample 10 minutes before the meal intake and one immediately prior the meal intake. The meal consists of a sugar-rich breakfast, which must be ingested within 15 minutes. Blood samples will then be collected at 10, 20, 30, 45, 60, 90, and 120 minutes afterwards. Blood glucose will be measured at the Department of Clinical Chemistry at the hospital, according to clinical routines.
1 secondary outcome
Changes of gastrointestinal and extraintestinal symptoms after a meal intake assesssed by self-reported completion on visual analog scales
Time frame: 2 hours
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 29 Apr 2026.
- Individual participant dataSharing planned: No. Due to ethical rules in Sweden, we can not share individual data. The participants have written an informed concent that data will be presented group wise.
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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.
Mauro D'Amato Professor contact
Cecilia Kennbäck, Registered Nurse study chair
Department of Internal Medicine, Skåne University Hospital, 20502 Malmö
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal load in people with IBS - Irritable Bowel Syndrome and Sucrase-Isomaltase Deficiency, 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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?
Contact Bodil Ohlsson C Professor, MD, PhD (+46+402712660, bodil.ohlsson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of blood glucose after a meal intake (time frame: 2 hours). 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 29 Apr 2026.