Sucrase Isomaltase DeficiencyGenMalCarb2NCT06770907
Genetic Carbohydrate Maldigestion As Model to Study Food Hypersensitivity Mechanism (WORK PACKAGE 2)
An observational study of Sucrase Isomaltase Deficiency, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
Irritable bowel syndrome (IBS) affects one in seven people with gastrointestinal (GI) symptoms that are detected without an established underlying organic cause. IBS strongly impacts quality of life, is a leading cause of work absenteeism, and consumes 0.5% of the healthcare annual budget. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sucrase Isomaltase Deficiency
- What is being tested?
- Blood, stool and saliva collection, Questionnaire completion and Magnetic Resonance Imaging (MRI) and Breath test
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2025to Mar 2026
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Single-centre study. CSID subjects will be identified and recruited either with the help of the PPI group through advertisements on social media or flyers at Clinical Genetics and Genomic Conferences and Adult Metabolic Disorder Conferences. Healthy participants will be recruited through social media advertisements and posters.
Who may be able to join
- Aged ≥18 (all groups)
- Subjects with genetically proven CSID
- Previous negative endoscopy with biopsies excluding IBD or microscopic colitis in people above 50 years old.
- Negative relevant additional screening (including exclusion of coeliac disease with TTG and IgA)
- Ability to conform to the study protocol including the sucrose challenge.
- Aged ≥18 years
Show all 9Show fewer
- Absence of Rome III IBS criteria
- Non-SI variant confirmed (group 1) or Single-SI variants confirmed (group 2) or Double - SI variants confirmed (group 3)
- Ability to conform to the study protocol including the sucrose challenge
Who cannot join
- Subjects on opioids and use of drugs known to alter GI motility for the duration of the study.
- Presence of concurrent organic gastrointestinal disease (inflammatory bowel disease, coeliac disease, cancer), or a major disease such as diabetes, uncontrolled thyroid disease
- Any history of bowel surgery (not appendectomy or cholecystectomy)
- Contraindication to MRI scanning
- Having taken part in another interventional research study within 3 months
- Concurrent major confounding condition (e.g. alcohol or substance abuse in the last 2 years) based on the study clinician's judgement.
Show all 12Show fewer
- Person presenting with a functional or organic GI disorder.
- Person presenting with underlying disease that may involve the GI tract (e.g. Parkinson's disease) or be associated with GI symptoms (e.g. anorexia nervosa, major depression).
- Any history of bowel surgery (not appendectomy or cholecystectomy)
- Contraindication to MRI scanning
- Having taken part in another interventional research study within 3 months
- Concurrent major confounding condition (e.g. alcohol or substance abuse in the last 2 years) based on the clinician's judgement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
University of Nottingham
Nottingham, NG7 2UH
Maura Corsetti, Medical Doctor, 0044 7976448821, maura.corsetti@nottingham.ac.uk
About this study
Official title: Genetic Carbohydrate Maldigestion As a Model to Study Food Hypersensitivity Mechanism and Guide Personalised Treatment Using a Non-invasive Multiparametric Test (WORK PACKAGE 2)
Irritable bowel syndrome (IBS) affects one in seven people with gastrointestinal (GI) symptoms that are detected without an established underlying organic cause. IBS strongly impacts quality of life, is a leading cause of work absenteeism, and consumes 0.5% of the healthcare annual budget. It manifests in women more than men with symptoms including abdominal pain, bloating, constipation (IBS-C), diarrhoea (IBS-D), and mixed presentations (IBS-M). The development of therapeutic options is hampered by the heterogeneity of IBS, the lack of specificity of its symptom-based definitions, and the poor understanding of the underlying pathophysiological mechanisms.
Many people with IBS find that certain foods (particularly carbohydrates) trigger their symptoms and avoiding such foods has been shown to be effective in IBS. An example of such a diet is the low-FODMAP (fermentable oligo-, di-, monosaccharides and polyols) exclusion diet, developed by researchers at Monash University. This has suggested that the food-symptom relation may involve malabsorption of carbohydrates due to inefficient enzymatic breakdown of polysaccharides. However, only a percentage of subjects respond to this diet. Overall, the current findings relating to SI, suggest a strong potential for effective personalized therapeutic (dietary) interventions in subgroups of IBS subjects and suggest similar mechanisms should be investigated in relation to other genes involved in the digestion and absorption of carbohydrates (CDGs). This project aims to understand what the mechanisms for GI symptoms in subjects with these genetic alterations are. Aim of the study is to assess the gut response to a sucrose challenge in single-and double-carriers of the common hypomorphic sucrase-isomaltase variant p. (Val15Phe) vs non- carriers (negative controls) and CSID subjects (positive controls), applying an MRI multiparametric test combined with a breath test.
- Conditions
- Sucrase Isomaltase Deficiency
- Being tested
- Blood, stool and saliva collection, Questionnaire completion, Magnetic Resonance Imaging (MRI) and Breath test
- Keywords
- sucrose isomaltase deficiency
- Medical subject headings
- Sucrase-isomaltase deficiency, congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood, stool and saliva collectionOther
Blood, stool and saliva collection
Questionnaire completionOther
Questionnaire on:
- Hospital Anxiety and Depression Score (HADS) for adults
- Total glucose and fructose and excess fructose, lactose, sorbitol, mannitol, oligosaccharides (Fructans and GOS) as measured by CNAQ questionnaire for adults and children
- Patient Health Questionnaire 12 (PHQ-12) Somatic Symptom scale
Magnetic Resonance Imaging (MRI) and Breath testDiagnostic test
MRI scans and breath test samples collected after drink test with sucrose
| Study group | Role | What they receive |
|---|---|---|
| Congenital Sucrase-Isomaltase Deficiency | Subjects with congenital sucrase-isomaltase deficiency (CSID) who report symptoms Receives: Other: Blood, stool and saliva collection; Other: Questionnaire completion; Diagnostic Test: Magnetic Resonance Imaging (MRI) and Breath test | |
| Healthy subjects | Subjects without CSID Receives: Other: Blood, stool and saliva collection; Other: Questionnaire completion; Diagnostic Test: Magnetic Resonance Imaging (MRI) and Breath test | |
| Asymptomatic controls single carriers | Subjects single carriers for sucrose isomaltase deficiency without symptoms Receives: Other: Blood, stool and saliva collection; Other: Questionnaire completion; Diagnostic Test: Magnetic Resonance Imaging (MRI) and Breath test | |
| Asymptomatic controls double carriers | Subjects double carriers for sucrose isomaltase deficiency without symptoms Receives: Other: Blood, stool and saliva collection; Other: Questionnaire completion; Diagnostic Test: Magnetic Resonance Imaging (MRI) and Breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve
Area under curve (AUC) of the change from baseline for the MRI measured small bowel water content after the drink test with sucrose
Measured: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Secondary outcomes (20)
Habitual diet questionnaire
subject will report food eaten at each meal
Measured: during 4 days before the MRI study
MRI measured colon free water content
MRI measured colon free water content, (in arbitrary units) after the drink test
Measured: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
MRI measured small bowel and colon gas content
small bowel and colon gas content (in arbitrary units) after the drink test
Measured: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
MRI measured small bowel and colon volume
small bowel and colon volume in arbritary units after drink test
Measured: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
MRI measured oro-caecal transit time
oro-caecal transit time (OCTT), (in arbitrary units) after the drink test
Measured: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Breath hydrogen and methane concentration measured in parts per million after drink test
Measured: baseline and then 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Symptoms of nausea, gas/flatulence, bloating and pain/discomfort measured using a Composite Symptom Score after the drink test
Measured: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Total glucose and fructose and excess fructose, lactose, sorbitol, mannitol, oligosaccharides (Fructans and GOS) as measured by Comprehensive Nutrition Assessment Questionnaire
CNAQ questionnaires results
Measured: time 0
Hospital Anxiety and Depression Score
scale measuring the score of anxiety and depression
Measured: time 0
The Patient Health Questionnaire 12
Scale measuring the psychosomatic score
Measured: Time 0
Stool microbiota taxonomic
Analysis of of microbiota taxonomic in the two stool samples collected by patient during the day before the MRI study day
Measured: Up to 3 days before the MRI study
Stool microbiota alpha and beta diversity measurements
Analysis of alfa and beta diversity of microbiota in the two stool samples collected by patient before the study day
Measured: Up to three days before the MRI study day
Serum levels of short chain fatty acids
Serum levels
Measured: At baseline and 0, 60, 120, 180, 240, 300 minutes after the drink test
Circulating blood glucose levels
Measured: Baseline and then 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Serum levels of surrogates of intestinal permeability (occludin, lipopolysaccharide binding protein)
Serum levels
Measured: At baseline and 0, 60, 120, 180, 240, 300 minutes after the drink test
Serum levels of lipidome and free fatty acids
Serum levels
Measured: At baseline and 0, 60, 120, 180, 240, 300 minutes after the drink test
Serum levels of total serum N-glycome and glucose
Serum levels
Measured: At baseline and 0, 60, 120, 180, 240, 300 minutes after the drink test
Food and drink avoidance questionnaire
patients will respond to the below questions:
- Name of the food or drink you try to avoid.
- Please tell us if you try to avoid this food or drink partially or completely? Approximately how long you have tried to avoid this food or drink partially or completely.
Why do you try to avoid this food or drink partially or completely (including if you have been told to avoid it by a health care professional such as a doctor or dietitian)
Measured: at time 0
Leeds Food Preference Questionnaire
The LFPQ consists of two tasks requiring different interaction from the participant. One task requires an explicit evaluation of each food item using visual analogue scales. The other requires a quick choice to be made between paired combinations of foods. The order of task completion is randomised.
Measured: at time 0
Food Craving Questionnaire - State (FCQ-S)
participants respond to 14 questions about sugary food and they will respond with a scale from 1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree.
Measured: at time 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
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 University of NottinghamThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- cic bioGune, Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel, University of Veterinary Medicine Hannover
- Responsible party
- Principal investigator, Maura Corsetti, University of Nottingham
- Investigators
- Maura Corsetti, Medical Doctor, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770907
- Sponsor's protocol ID
- FMHS 215-0624
- Acronym
- GenMalCarb2
- Status last verified
- Jan 2025
- First submitted
- 21 Nov 2024
- Last updated
- 13 Jan 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 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Carbohydrate Maldigestion As a Model to Study Food Hypersensitivity Mechanism and Guide Personalised Treatment Using a Non-invasive Multiparametric Test (WORK PACKAGE 2)
- ClinicalTrials.gov ID
- NCT06770907
- Acronym / sponsor ID
- GenMalCarb2 / FMHS 215-0624
- Conditions
- Sucrase Isomaltase Deficiency
- Keywords
- sucrose isomaltase deficiency
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- cic bioGune, Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel, University of Veterinary Medicine Hannover
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 13 Jan 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.
Irritable bowel syndrome (IBS) affects one in seven people with gastrointestinal (GI) symptoms that are detected without an established underlying organic cause. IBS strongly impacts quality of life, is a leading cause of work absenteeism, and consumes 0.5% of the healthcare annual budget. It manifests in women more than men with symptoms including abdominal pain, bloating, constipation (IBS-C), diarrhoea (IBS-D), and mixed presentations (IBS-M). The development of therapeutic options is hampered by the heterogeneity of IBS, the lack of specificity of its symptom-based definitions, and the poor understanding of the underlying pathophysiological mechanisms.
Many people with IBS find that certain foods (particularly carbohydrates) trigger their symptoms and avoiding such foods has been shown to be effective in IBS. An example of such a diet is the low-FODMAP (fermentable oligo-, di-, monosaccharides and polyols) exclusion diet, developed by researchers at Monash University. This has suggested that the food-symptom relation may involve malabsorption of carbohydrates due to inefficient enzymatic breakdown of polysaccharides. However, only a percentage of subjects respond to this diet. Overall, the current findings relating to SI, suggest a strong potential for effective personalized therapeutic (dietary) interventions in subgroups of IBS subjects and suggest similar mechanisms should be investigated in relation to other genes involved in the digestion and absorption of carbohydrates (CDGs). This project aims to understand what the mechanisms for GI symptoms in subjects with these genetic alterations are. Aim of the study is to assess the gut response to a sucrose challenge in single-and double-carriers of the common hypomorphic sucrase-isomaltase variant p. (Val15Phe) vs non- carriers (negative controls) and CSID subjects (positive controls), applying an MRI multiparametric test combined with a breath test.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Congenital Sucrase-Isomaltase Deficiency | – | Other: Blood, stool and saliva collection, Other: Questionnaire completion, Diagnostic Test: Magnetic Resonance Imaging (MRI) and Breath testSubjects with congenital sucrase-isomaltase deficiency (CSID) who report symptoms |
| Healthy subjects | – | Other: Blood, stool and saliva collection, Other: Questionnaire completion, Diagnostic Test: Magnetic Resonance Imaging (MRI) and Breath testSubjects without CSID |
| Asymptomatic controls single carriers | – | Other: Blood, stool and saliva collection, Other: Questionnaire completion, Diagnostic Test: Magnetic Resonance Imaging (MRI) and Breath testSubjects single carriers for sucrose isomaltase deficiency without symptoms |
| Asymptomatic controls double carriers | – | Other: Blood, stool and saliva collection, Other: Questionnaire completion, Diagnostic Test: Magnetic Resonance Imaging (MRI) and Breath testSubjects double carriers for sucrose isomaltase deficiency without symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Single-centre study. CSID subjects will be identified and recruited either with the help of the PPI group through advertisements on social media or flyers at Clinical Genetics and Genomic Conferences and Adult Metabolic Disorder Conferences. Healthy participants will be recruited through social media advertisements and posters.
Key inclusion criteria (9 listed)
- Aged ≥18 (all groups)
- Subjects with genetically proven CSID
- Previous negative endoscopy with biopsies excluding IBD or microscopic colitis in people above 50 years old.
- Negative relevant additional screening (including exclusion of coeliac disease with TTG and IgA)
- Ability to conform to the study protocol including the sucrose challenge.
Key exclusion criteria (12 listed)
- Subjects on opioids and use of drugs known to alter GI motility for the duration of the study.
- Presence of concurrent organic gastrointestinal disease (inflammatory bowel disease, coeliac disease, cancer), or a major disease such as diabetes, uncontrolled thyroid disease
- Any history of bowel surgery (not appendectomy or cholecystectomy)
- Contraindication to MRI scanning
- Having taken part in another interventional research study within 3 months
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 |
|---|---|---|
| Blood, stool and saliva collectionBlood, stool and saliva collection | Other | Asymptomatic controls double carriers, Asymptomatic controls single carriers, Congenital Sucrase-Isomaltase Deficiency, Healthy subjects |
| Questionnaire completionQuestionnaire on: * Hospital Anxiety and Depression Score (HADS) for adults * Total glucose and fructose and excess fructose, lactose, sorbitol, mannitol, oligosaccharides (Fructans and GOS) as measured by CNAQ questionnaire for adults and children * Patient Health Questionnaire 12 (PHQ-12) Somatic Symptom scale | Other | Asymptomatic controls double carriers, Asymptomatic controls single carriers, Congenital Sucrase-Isomaltase Deficiency, Healthy subjects |
| Magnetic Resonance Imaging (MRI) and Breath testMRI scans and breath test samples collected after drink test with sucrose | Diagnostic test | Asymptomatic controls double carriers, Asymptomatic controls single carriers, Congenital Sucrase-Isomaltase Deficiency, Healthy subjects |
Primary outcome
Area under the curve
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Area under curve (AUC) of the change from baseline for the MRI measured small bowel water content after the drink test with sucrose
20 secondary outcomes
Habitual diet questionnaire
Time frame: during 4 days before the MRI study
MRI measured colon free water content
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
MRI measured small bowel and colon gas content
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
MRI measured small bowel and colon volume
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
MRI measured oro-caecal transit time
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Breath hydrogen and methane concentration measured in parts per million after drink test
Time frame: baseline and then 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Symptoms of nausea, gas/flatulence, bloating and pain/discomfort measured using a Composite Symptom Score after the drink test
Time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Total glucose and fructose and excess fructose, lactose, sorbitol, mannitol, oligosaccharides (Fructans and GOS) as measured by Comprehensive Nutrition Assessment Questionnaire
Time frame: time 0
Hospital Anxiety and Depression Score
Time frame: time 0
The Patient Health Questionnaire 12
Time frame: Time 0
Stool microbiota taxonomic
Time frame: Up to 3 days before the MRI study
Stool microbiota alpha and beta diversity measurements
Time frame: Up to three days before the MRI study day
Serum levels of short chain fatty acids
Time frame: At baseline and 0, 60, 120, 180, 240, 300 minutes after the drink test
Circulating blood glucose levels
Time frame: Baseline and then 0, 15, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test
Serum levels of surrogates of intestinal permeability (occludin, lipopolysaccharide binding protein)
Time frame: At baseline and 0, 60, 120, 180, 240, 300 minutes after the drink test
Serum levels of lipidome and free fatty acids
Time frame: At baseline and 0, 60, 120, 180, 240, 300 minutes after the drink test
Serum levels of total serum N-glycome and glucose
Time frame: At baseline and 0, 60, 120, 180, 240, 300 minutes after the drink test
Food and drink avoidance questionnaire
Time frame: at time 0
Leeds Food Preference Questionnaire
Time frame: at time 0
Food Craving Questionnaire - State (FCQ-S)
Time frame: at time 0
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 13 Jan 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.
Maura Corsetti, Medical Doctor principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sucrase Isomaltase Deficiency, run by University of Nottingham at 1 site in United Kingdom.
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 9 inclusion and 12 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: opening soon, as of the sponsor's last update on 13 Jan 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 United Kingdom. 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 Maura Corsetti, Medical Doctor (+447976448821, maura.corsetti@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (time frame: 0, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes after the drink test). 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 13 Jan 2025.