Sucrase-Isomaltase DeficiencyNCT05688826
The Effect of Sugar Load in IBS Patients Depending on Sucrase-isomaltase Genes
A study testing Sugar in people with Sucrase-Isomaltase Deficiency and Irritable Bowel Syndrome, run by Region Skane at 1 site in Sweden.
Trial summary
The investigators know that many patients with irritable bowel syndrome (IBS) have functional variants of genes coding for sucrase-isomaltase enzymes. The investigators will now examine whether these functional variants are associated with defect degradation of sucrose and associated gastrointestinal symptoms Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sucrase-Isomaltase Deficiency, Irritable Bowel Syndrome
- What is being tested?
- Sugar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 4 Jan 2023to 23 Jun 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of our previous clinical trial with SSRD diet (NCT03306381)
Who cannot join
- Difficulties in taking blood samples
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Internal Medicine, Skåne University Hospital
Malmö, 20502
About this study
Official title: Comparison of Sugar Load Between Normal and Functional Variants of Sucrase-isomaltase Genes in IBS
The investigators know that many patients with irritable bowel syndrome (IBS) have functional variants of genes coding for sucrase-isomaltase enzymes. The investigators will now examine whether these functional variants are associated with defect degradation of sucrose and associated gastrointestinal symptoms
Read the detailed description
The investigators have in a previous study included IBS patients for treatment with a starch- and sucrose reduced diet (SSRD). The investigators found a great improvement of symptoms. The investigators gene-tested those patients, and now have the full identification of all functional variants encoding sucrase-isomaltase enzymes.
The investigators will invite patients from this previous study with normal genes and functional variants of genes. The patients will come fasting over night to the department of clinical research. The participants will ingest 75 g sugar dissolved in 0.8 dl water and flavored with lemon, to ingest during 5 minutes. After that, glucose will determined repeatedly up to 2 hours afterwards. At the same time, the participants have to assess their gastrointestinal sympotms on visual analogue scales (VAS).
The investigators will compare the raise in b-glucose and symptoms between the groups of patients, divided into gene expression.
- Being tested
- Sugar
- Keywords
- gastrointestinal symptoms, glucose
- Medical subject headings
- Sucrase-isomaltase deficiency, congenital, Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SugarDietary supplement
75 g sugar dissolved in 0.8 dl water and flavored with lemon. Ingested during 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| Sugar load | Experimental | Sugar dissolved in water will be ingested during 5 minutes Receives: Dietary Supplement: Sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline of blood glucose levels
Measurement of glucose levels in blood drawn from an intravenous needle and analyzed at the Department of Clinical Chemostry
Measured: From distribution repeatedly up to 2 hours
Change from baseline of gastrointestinal symptoms
Measurment of gastrointestinal symptoms on a visual analog scale measuring symptoms, range 0-100 mm, repeatedly at the same time points as blood glucose is measured. The higher scores, the worse symptoms.
Measured: From baseline and up to 2 hours, at the same time points as blood glucose is measured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start4 Jan 2023
- Primary completion27 Sep 2023
- Study completion23 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sucrase-Isomaltase DeficiencyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with normal genes and with functional variants of sucrase-isomaltase genes
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bodil Ohlsson, Region Skane
- Investigators
- Cecilia Kennback, Nurse, Study director, Department of Internal Medicine, Skåne University Hospital, Malmö
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688826
- Sponsor's protocol ID
- Sugarload-2023
- Status last verified
- Jun 2025
- First submitted
- 9 Jan 2023
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sugar Load Between Normal and Functional Variants of Sucrase-isomaltase Genes in IBS
- ClinicalTrials.gov ID
- NCT05688826
- Acronym / sponsor ID
- Sugarload-2023
- Keywords
- gastrointestinal symptoms, glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 4 Jan 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 23 Jun 2025 (actual)
- First posted
- 18 Jan 2023 (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 investigators know that many patients with irritable bowel syndrome (IBS) have functional variants of genes coding for sucrase-isomaltase enzymes. The investigators will now examine whether these functional variants are associated with defect degradation of sucrose and associated gastrointestinal symptoms
Detailed description
The investigators have in a previous study included IBS patients for treatment with a starch- and sucrose reduced diet (SSRD). The investigators found a great improvement of symptoms. The investigators gene-tested those patients, and now have the full identification of all functional variants encoding sucrase-isomaltase enzymes.
The investigators will invite patients from this previous study with normal genes and functional variants of genes. The patients will come fasting over night to the department of clinical research. The participants will ingest 75 g sugar dissolved in 0.8 dl water and flavored with lemon, to ingest during 5 minutes. After that, glucose will determined repeatedly up to 2 hours afterwards. At the same time, the participants have to assess their gastrointestinal sympotms on visual analogue scales (VAS).
The investigators will compare the raise in b-glucose and symptoms between the groups of patients, divided into gene expression.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with normal genes and with functional variants of sucrase-isomaltase genes
| Arm | Type | Receives |
|---|---|---|
| Sugar load | Experimental | Dietary Supplement: SugarSugar dissolved in water will be ingested during 5 minutes |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants of our previous clinical trial with SSRD diet (NCT03306381)
Key exclusion criteria (1 listed)
- Difficulties in taking blood samples
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 |
|---|---|---|
| Sugar75 g sugar dissolved in 0.8 dl water and flavored with lemon. Ingested during 5 minutes | Dietary supplement | Sugar load |
Primary outcome
Changes from baseline of blood glucose levels
Time frame: From distribution repeatedly up to 2 hours
Measurement of glucose levels in blood drawn from an intravenous needle and analyzed at the Department of Clinical Chemostry
Change from baseline of gastrointestinal symptoms
Time frame: From baseline and up to 2 hours, at the same time points as blood glucose is measured
Measurment of gastrointestinal symptoms on a visual analog scale measuring symptoms, range 0-100 mm, repeatedly at the same time points as blood glucose is measured. The higher scores, the worse symptoms.
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 27 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia Kennback, Nurse study director
Department of Internal Medicine, Skåne University Hospital, 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 Sugar in people with Sucrase-Isomaltase Deficiency and 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 1 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 27 Jun 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?
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?
Changes from baseline of blood glucose levels (time frame: From distribution repeatedly up to 2 hours). The study lists 2 primary outcomes in all. 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 27 Jun 2025.