Irritable Bowel SyndromeNCT05159115
Sucrase-isomaltase Deficiency as a Cause of Irritable Bowel Syndrome
A study testing Low-FODMAP diet and Starch- and Sucrose Reduced Diet (SSRD) in people with Irritable Bowel Syndrome and Sucrose Intolerance Due to Sucrase-Isomaltase Deficiency, run by Lovisenberg Diakonale Hospital.
Trial summary
Irritable bowel syndrome (IBS) is a functional disorder causing troublesome symptoms and reduced quality of life. It affects 10-20% of the population, hence creates large costs for society. About 30-40% of all IBS patients do not benefit from current treatment options. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Irritable Bowel Syndrome, Sucrose Intolerance Due to Sucrase-Isomaltase Deficiency, Carbohydrate; Malabsorption
- What is being tested?
- Low-FODMAP diet and Starch- and Sucrose Reduced Diet (SSRD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2022to 31 Dec 2027
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- BMI 18-30 kg/m2
- Referred for gastroscopic examination with suspected GI disorder
- Signed informed consent
- BMI 18-30 kg/m2
- IBS diagnosis according to Rome IV criteria
Who cannot join
- Unwilling or not capable of signing the informed consent
- Sucrase-isomaltase deficiency as a cause of symptoms in patients with irritable bowel syndrome (n=80)
- Inflammatory bowel disease, celiac disease or diabetes mellitus
- Chronic immune diseases affecting the GI-system
- Unwilling/unable to maintain a stable diet throughout the study period
- Use of antibiotic treatment for the last 4 weeks
- Currently on a restrictive diet
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Irritable bowel syndrome (IBS) is a functional disorder causing troublesome symptoms and reduced quality of life. It affects 10-20% of the population, hence creates large costs for society. About 30-40% of all IBS patients do not benefit from current treatment options. Sucrase-isomaltase (SI) deficiency is an unexplored condition, that may explain symptoms in IBS patients who experience no effect from today's treatments. Currently, a duodenal biopsy is the gold standard for the diagnosis of SI deficiency, however the condition is not well investigated. A 13C-labelled breath test holds promise as a non-invasive alternative, but it has not previously been validated.
This project will address the knowledge gap related to a possible association between SI deficiency and IBS by addressing two research questions that have never been answered before. We aim to:
- Validate the 13C-labelled breath test as a diagnostic tool by assessing the strength of the association between the breath test and SI activity measured in duodenal biopsies
- Use the 13C-labelled breath test in a randomized dietary crossover trial comparing a starch and sucrose reduced diet (SSRD) with the standard low-FODMAP diet in IBS patients, to evaluate whether SI activity is associated with dietary changes according to symptom severity and gut microbiota composition
Read the detailed description
The projects includes two studies:
Study 1: Validation of the 13C-labelled breath test to diagnose sucrase-isomaltase deficiency
Background: In order to validate the 13C-sucrose breath test to diagnose SI deficiency, the test result must be compared to the "gold standard" method for diagnosis; i.e. measurements of enzyme activity from intestinal biopsies by "The Dahlquist Method", and a reference material must be established.
Objective: To compare results from the 13C-labelled breath test to enzyme activity measured in biopsies collected from the proximal small intestine in a limited patient group referred for a gastroscopic examination.
Design: A cross-sectional study.
Primary endpoint: SI activity as measured with a breath test and enzyme activity with assay of biopsy material.
Recruitment and patient characteristics: Patients referred for gastroscopic examination with duodenal biopsies and with suspected GI disorder, will be included consecutively.
Sample size: We aim to include 40 patients. No studies validating breath test results in our patient group are available. However, based on preliminary results suggesting that 35% of IBS patients have SI deficiency,13 we are 95% likely to find between 8 and 21 patients with SI deficiency when examining 40 patients. Assuming 80% concordance between the two methods to (correct proportion of successes), we would need 12 positive cases. Thus, if 40 individuals are included, the study is sufficiently powered (alpha=5% and beta=20%, using McNemar's test of concordance).
Study 2: Sucrase-isomaltase deficiency as a cause of symptoms in patients with irritable bowel syndrome
Objectives: To examine the effect of a 4-week SSRD on GI- and extraintestinal symptoms, gut microbiota composition and fecal fermentation in patients with IBS (with and without SI deficiency), and compare the SSRD with a 4-week low-FODMAP diet to investigate whether the patients with a breath test result indicating SI deficiency respond better to the SSRD than the patients with normal SI activity. Gut microbiota have been suggested to have a central role in IBS etiology, hence evaluation of gut microbiota composition and fecal fermentation will be included to increase the knowledge regarding the effects of dietary change on gut microbiota composition and activity related to SI deficiency.
Design: A randomized, open clinical crossover trial with a dietary intervention in a group of IBS patients, lasting for 4+4 weeks (SSRD vs. low-FODMAP) with a 1-week wash-out period in between. Breath tests will be taken at inclusion, but the results will be "blinded", e.g. not available for anyone conducting the trial before end of the study. A SSRD will be compared to the low-FODMAP diet. All participants will be given dietary advice from a registered clinical dietitian. Briefly, all forms of sucrose-containing foods (e.g. sweets, jam, and cakes) should be avoided, and foods rich in starch should be reduced on the SSRD.
Primary endpoint: Symptom severity by IBS-Symptom Severity Scale (IBS-SSS).
Secondary endpoints: Gut microbiota composition, fecal fermentation measured by short chain fatty acids (SCFAs) and assessment of quality of life by the Patient Reported Outcome Measurement Information System (PROMIS-29).
Recruitment and patient characteristics: IBS patients referred to the outpatient clinic at the Department of Gastroenterology at Lovisenberg Diaconal Hospital for dietary guidance by a registered dietitian will be consecutively included.
Sample size: The primary end point is change in IBS symptom severity (IBS-SSS) at the end of the treatment period relative to baseline, and the proportion of responders to the dietary intervention is based on the recommended cut-off of a reduction (ie, improvement) in total IBS-SSS score of 50 points, which is considered to be clinically meaningful improvement. To plan our sample size, we performed a power calculation based on the ability to detect a difference between the two diets in reduction of IBS-SSS score of at least 50 points with 80% power, assuming an SD of 100. The calculation indicated that we would need 64 patients. To allow for 15-20% drop-out, we aim to include 80 patients.
- Conditions
- Irritable Bowel Syndrome, Sucrose Intolerance Due to Sucrase-Isomaltase Deficiency, Carbohydrate; Malabsorption, Sucrase Isomaltase Deficiency, Functional Gastrointestinal Disorders
- Being tested
- Low-FODMAP diet, Starch- and Sucrose Reduced Diet (SSRD)
- Medical subject headings
- Irritable Bowel Syndrome, Malabsorption Syndromes, Sucrase-isomaltase deficiency, congenital, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-FODMAP dietOther
4 weeks of a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs)
Starch- and Sucrose Reduced Diet (SSRD)Other
4 weeks of a diet low in starch and sucrose
| Study group | Role | What they receive |
|---|---|---|
| Low-FODMAP diet | Active comparator | Patients with IBS on a 4-week low-FODMAP diet. Receives: Other: Low-FODMAP diet |
| Starch- and Sucrose Reduced Diet | Experimental | Patients with IBS on a s 4-week Starch- and Sucrose Reduced Diet (SSRD). Receives: Other: Starch- and Sucrose Reduced Diet (SSRD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS symptom severity
Symptom severity measured by the IBS-Symptom Severity Scale (IBS-SSS)
Measured: 4 weeks
Secondary outcomes (3)
Gut microbiota composition
Analysis of fecal samples for evaluation of microbiota composition in fecal samples collected at baseline and after each 4-week diet intervention
Measured: 4 weeks
Fecal fermentation measured by short chain fatty acids (SCFAs)
Analysis of SCFAs in fecal samples collected at baseline and after each 4-week diet intervention
Measured: 4 weeks
Quality of life in IBS
Assessment of quality of life by the Patient Reported Outcome Measurement Information System (PROMIS-29)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start14 Mar 2022 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lovisenberg Diakonale Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159115
- Sponsor's protocol ID
- MED 358
- Status last verified
- Nov 2021
- First submitted
- 6 Dec 2021
- Last updated
- 2 Feb 2022
- Results posted
- 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 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sucrase-isomaltase Deficiency as a Cause of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT05159115
- Acronym / sponsor ID
- MED 358
- Conditions
- Irritable Bowel Syndrome, Sucrose Intolerance Due to Sucrase-Isomaltase Deficiency, Carbohydrate; Malabsorption, Sucrase Isomaltase Deficiency, Functional Gastrointestinal Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Lovisenberg Diakonale HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- 14 Mar 2022 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Dec 2021 (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 functional disorder causing troublesome symptoms and reduced quality of life. It affects 10-20% of the population, hence creates large costs for society. About 30-40% of all IBS patients do not benefit from current treatment options. Sucrase-isomaltase (SI) deficiency is an unexplored condition, that may explain symptoms in IBS patients who experience no effect from today's treatments. Currently, a duodenal biopsy is the gold standard for the diagnosis of SI deficiency, however the condition is not well investigated. A 13C-labelled breath test holds promise as a non-invasive alternative, but it has not previously been validated.
This project will address the knowledge gap related to a possible association between SI deficiency and IBS by addressing two research questions that have never been answered before. We aim to:
- Validate the 13C-labelled breath test as a diagnostic tool by assessing the strength of the association between the breath test and SI activity measured in duodenal biopsies
- Use the 13C-labelled breath test in a randomized dietary crossover trial comparing a starch and sucrose reduced diet (SSRD) with the standard low-FODMAP diet in IBS patients, to evaluate whether SI activity is associated with dietary changes according to symptom severity and gut microbiota composition
Detailed description
The projects includes two studies:
Study 1: Validation of the 13C-labelled breath test to diagnose sucrase-isomaltase deficiency
Background: In order to validate the 13C-sucrose breath test to diagnose SI deficiency, the test result must be compared to the "gold standard" method for diagnosis; i.e. measurements of enzyme activity from intestinal biopsies by "The Dahlquist Method", and a reference material must be established.
Objective: To compare results from the 13C-labelled breath test to enzyme activity measured in biopsies collected from the proximal small intestine in a limited patient group referred for a gastroscopic examination.
Design: A cross-sectional study.
Primary endpoint: SI activity as measured with a breath test and enzyme activity with assay of biopsy material.
Recruitment and patient characteristics: Patients referred for gastroscopic examination with duodenal biopsies and with suspected GI disorder, will be included consecutively.
Sample size: We aim to include 40 patients. No studies validating breath test results in our patient group are available. However, based on preliminary results suggesting that 35% of IBS patients have SI deficiency,13 we are 95% likely to find between 8 and 21 patients with SI deficiency when examining 40 patients. Assuming 80% concordance between the two methods to (correct proportion of successes), we would need 12 positive cases. Thus, if 40 individuals are included, the study is sufficiently powered (alpha=5% and beta=20%, using McNemar's test of concordance).
Study 2: Sucrase-isomaltase deficiency as a cause of symptoms in patients with irritable bowel syndrome
Objectives: To examine the effect of a 4-week SSRD on GI- and extraintestinal symptoms, gut microbiota composition and fecal fermentation in patients with IBS (with and without SI deficiency), and compare the SSRD with a 4-week low-FODMAP diet to investigate whether the patients with a breath test result indicating SI deficiency respond better to the SSRD than the patients with normal SI activity. Gut microbiota have been suggested to have a central role in IBS etiology, hence evaluation of gut microbiota composition and fecal fermentation will be included to increase the knowledge regarding the effects of dietary change on gut microbiota composition and activity related to SI deficiency.
Design: A randomized, open clinical crossover trial with a dietary intervention in a group of IBS patients, lasting for 4+4 weeks (SSRD vs. low-FODMAP) with a 1-week wash-out period in between. Breath tests will be taken at inclusion, but the results will be "blinded", e.g. not available for anyone conducting the trial before end of the study. A SSRD will be compared to the low-FODMAP diet. All participants will be given dietary advice from a registered clinical dietitian. Briefly, all forms of sucrose-containing foods (e.g. sweets, jam, and cakes) should be avoided, and foods rich in starch should be reduced on the SSRD.
Primary endpoint: Symptom severity by IBS-Symptom Severity Scale (IBS-SSS).
Secondary endpoints: Gut microbiota composition, fecal fermentation measured by short chain fatty acids (SCFAs) and assessment of quality of life by the Patient Reported Outcome Measurement Information System (PROMIS-29).
Recruitment and patient characteristics: IBS patients referred to the outpatient clinic at the Department of Gastroenterology at Lovisenberg Diaconal Hospital for dietary guidance by a registered dietitian will be consecutively included.
Sample size: The primary end point is change in IBS symptom severity (IBS-SSS) at the end of the treatment period relative to baseline, and the proportion of responders to the dietary intervention is based on the recommended cut-off of a reduction (ie, improvement) in total IBS-SSS score of 50 points, which is considered to be clinically meaningful improvement. To plan our sample size, we performed a power calculation based on the ability to detect a difference between the two diets in reduction of IBS-SSS score of at least 50 points with 80% power, assuming an SD of 100. The calculation indicated that we would need 64 patients. To allow for 15-20% drop-out, we aim to include 80 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-FODMAP diet | Active comparator | Other: Low-FODMAP dietPatients with IBS on a 4-week low-FODMAP diet. |
| Starch- and Sucrose Reduced Diet | Experimental | Other: Starch- and Sucrose Reduced Diet (SSRD)Patients with IBS on a s 4-week Starch- and Sucrose Reduced Diet (SSRD). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent
- BMI 18-30 kg/m2
- Referred for gastroscopic examination with suspected GI disorder
- Signed informed consent
- BMI 18-30 kg/m2
Key exclusion criteria (7 listed)
- Unwilling or not capable of signing the informed consent
- Sucrase-isomaltase deficiency as a cause of symptoms in patients with irritable bowel syndrome (n=80)
- Inflammatory bowel disease, celiac disease or diabetes mellitus
- Chronic immune diseases affecting the GI-system
- Unwilling/unable to maintain a stable diet throughout the study period
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 diet4 weeks of a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) | Other | Low-FODMAP diet |
| Starch- and Sucrose Reduced Diet (SSRD)4 weeks of a diet low in starch and sucrose | Other | Starch- and Sucrose Reduced Diet |
Primary outcome
IBS symptom severity
Time frame: 4 weeks
Symptom severity measured by the IBS-Symptom Severity Scale (IBS-SSS)
3 secondary outcomes
Gut microbiota composition
Time frame: 4 weeks
Fecal fermentation measured by short chain fatty acids (SCFAs)
Time frame: 4 weeks
Quality of life in IBS
Time frame: 4 weeks
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 2 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Questions about this trial
What is this clinical trial studying?
A study testing Low-FODMAP diet and Starch- and Sucrose Reduced Diet (SSRD) in people with Irritable Bowel Syndrome and Sucrose Intolerance Due to Sucrase-Isomaltase Deficiency, run by Lovisenberg Diakonale Hospital.
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 6 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: opening soon, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Jørgen Valeur, PhD (0047 23225140, jorgen.valeur@lds.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS symptom severity (time frame: 4 weeks). 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 2 Feb 2022.