Irritable Bowel SyndromePROT-IBSNCT03869359
The Effect of Gluten in Patients With Irritable Bowel Syndrome and Healthy Volunteers
A study testing Gluten-free diet with gluten powder in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Patients with Irritable Bowel Syndrome (IBS) often link their symptoms to foods. Interest in dietary management recently increased, including the use of a gluten-free diet. To investigate relation of gluten-free diet (GFD) and IBS, a randomized, double-blind, placebo-controlled cross-over trial will be carried out in… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Gluten-free diet with gluten powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2018to 1 Oct 2019
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients with IBS according to Rome IV criteria
Who cannot join
- allergy or documented intolerance to food,
- severe cardiovascular, hepatic, neurological or psychiatric disease
- serious gastrointestinal disease: including celiac disease and inflammatory bowel diseases (IBD),
- diabetes
- bowel dysfunction related to previous surgery
- pregnant or lactating women
- usage of antibiotics within 4 weeks before inclusion
- strict avoidance of foods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Gluten in Patients With Irritable Bowel Syndrome and Healthy Volunteers: a Randomized, Placebo-controlled Double-blind Cross-over Trial
Patients with Irritable Bowel Syndrome (IBS) often link their symptoms to foods. Interest in dietary management recently increased, including the use of a gluten-free diet.
To investigate relation of gluten-free diet (GFD) and IBS, a randomized, double-blind, placebo-controlled cross-over trial will be carried out in adults (>18) and patients with IBS according to Rome IV criteria. The aim is to assess gluten-free versus gluten-containing diet in IBS patients and Healthy Volunteers.
Read the detailed description
The study is a randomized, double-blind, placebo-controlled, cross-over trial.
The aim is to assess the effects of gluten-free diet (GFD) compared to gluten-containing diet (GCD) in IBS patients and Healthy Volunteers on gastrointestinal symptoms, visceral sensitivity, bacterial fermentation, psychological factors and quality of life. The primary hypothesis is that GFD decreases gastrointestinal symptoms compared to GCD and that this change is accompanied with reduced visceral sensitivity and change in bacterial fermentation. The secondary hypothesis is that GFD positively influences psychological factors and quality of life.
IBS patients (Rome IV) and Healthy Volunteers are challenged with gluten in this randomized, double-blind, placebo-controlled, cross-over study. They start with GFD or GCD and cross over to the other intervention (both for 14 days). In between there is a wash-out period of at least 14 days. The subjects will get gluten-free meals (lunch and dinner) and have to sprinkle powder over the meals, concealed in sachets with either gluten (vital gluten) or placebo (rice starch). The subjects will follow a strict GFD during the GFD and GCD periods. The subjects will eat and drink as before the study during the washout period.
Primary outcomes are change in gastrointestinal symptoms, assessed by questionnaires, including IBS Severity Scoring System (IBS-SSS) and Gastrointestinal Symtom Rating Scale-IBS (GSRS-IBS). A 50-point reduction in IBS-SSS indicates clinical response. Bacterial fermentation (exhaled hydrogen and methane) and visceral sensitivity will be measured using the Lactulose-Nutrient Challenge Test. Secondary outcomes are change in psychological factors and quality of life assessed by questionnaires, including CSI, HADS, HSPS, IBSQOL, PHQ-15 and VSI.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Gluten-free diet with gluten powder, Gluten-free diet with placebo powder
- Keywords
- gluten-free diet, gluten-containing diet, microbiota, metabolomics, healthy volunteers
- 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.
Gluten-free diet with gluten powderOther
The subjects will sprinkle gluten powder over their meals, twice a day. (14 g/day vital gluten: Real Foods, Edinburgh, United Kingdom). Plastic sachet marked with B (WePack, Derbyshire, United Kingdom). Free of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs).
Gluten-free diet with placebo powderOther
The subjects will sprinkle placebo powder over their meals, twice a day. (14 g/day rice starch: Doves Farm Foods Ltd., Berkshire, United Kingdom) Plastic sachets marked with A (WePack, Derbyshire, United Kingdom). Low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Gluten-free diet with placebo powder vs Gluten-free diet with gluten powder Receives: Other: Gluten-free diet with gluten powder; Other: Gluten-free diet with placebo powder |
| Group B | Experimental | Gluten-free diet with gluten powder vs Gluten-free diet with placebo powder Receives: Other: Gluten-free diet with gluten powder; Other: Gluten-free diet with placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS)
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) is a validated questionnaire that incorporates typical IBS symptoms such as abdominal pain, abdominal distension and bowel dysfunction, as well as quality of life. Subjects rated their symptoms on a visual analogue scale. The maximum achievable score is 500 points (sum of the 5 scales). A reduction in the total IBS-SSS score of at least 50 points is considered to indicate a clinically significant improvement in symptoms. The scale can also be used to classify IBS symptoms severity: <75 points (no symptoms), 75-175 points (mild symptoms), 175-300 points (moderate symptoms) and >300 points (severe symptoms). Measured after both dietary periods and at baseline of both periods.
Measured: Baseline(day 0), day 14, day 28, day 42
Change in Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRS-IBS)
Change in Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRS-IBS) measures symptom severity and symptom frequency in IBS patients and is a reliable and validated questionnaire. Thirteen questions are evaluated and rated from 1 (no discomfort at all) to 7 (very severe discomfort) on a Likert scale. The total scores can range from 13 to 91 (sum of the domains). The GSRS-IBS evaluates 5 domains: abdominal pain, bloating, constipation, diarrhea and satiety. Measured after both dietary periods and at baseline of both periods.
Measured: Baseline(day 0), day 14, day 28, day 42
Change in stool frequency, measured by Bristol Stool Form (BSF)
Change in Bristol Stool Form, stool frequency per day after both dietary periods
Measured: Day 14, Day 42
Change in Visceral Sensitivity and Bacterial Fermentation
Visceral Sensitivity and Bacterial Fermentation measured by the Lactulose-Nutrient Challenge Test.
Measured: Baseline(day 0), day 14, day 28, day 42
Secondary outcomes (9)
Change in Central Sensitization Inventory (CSI) score
The Central Sensitization Inventory (CSI) measures central sensitization related symptoms with 25 questions with a maximum score of 100. A high score indicates high likelihood of central sensitization. Measured after both dietary periods and at baseline of both periods.
Measured: Baseline(day 0), day 14, day 28, day 42
Change in Hospital Anxiety and Depression Scale (HADS) score
The Hospital Anxiety and Depression Scale (HADS) contains 7 items for depression and 7 for anxiety. Each item is scored from 0 to 3, and therefore the total score per subscale can range from 0 to 21. When subjects score >10 on 1 or 2 of the subscales, clinically significant psychological distress (anxiety or depression) is likely present. Measured after both dietary periods and at baseline of both periods.
Measured: Baseline(day 0), day 14, day 28, day 42
Change in Highly Sensitive Person Scale (HSPS)
The Highly Sensitive Person Scale (HSPS) contains 27 items and is a valid and reliable questionnaire that measures sensory-processing sensitivity in individuals. Each item is scored from 1 to 7, and therefore the total score can range from 27 to 189. Higher scores indicate high sensory-processing sensitivity. Measured after both dietary periods and at baseline of both periods.
Measured: Baseline(day 0), day 14, day 28, day 42
Change in Irritable Bowel Syndrome Quality of Life Questionnaire (IBSQOL)
The Irritable Bowel Syndrome Quality of Life Questionnaire (IBSQOL) is a 30-item questionnaire that measures quality of life specific to IBS. The IBSQOL is validated and can be used to assess the impact of IBS and possible treatment interventions on quality of life. The following domains are measured: emotional health, mental health, energy, sleep, food/diet, social role, physical functioning, physical role and sexual relations. Scores range from 0 to 100% per domain. Higher scores indicate that IBS influences quality of life greater. Measured after both dietary periods and at baseline of both periods.
Measured: Baseline(day 0), day 14, day 28, day 42
Change in Patient health questionnaire-15 (PHQ-15)
The (PHQ-15) is a validated questionnaire that evaluates 15 somatic symptoms and can be used as a screening tool for somatization in clinical research. The maximum score for men is 28 and 30 for women due to a question about menstrual problems. Measured after both dietary periods and at baseline of both periods.
Measured: Baseline(day 0), day 14, day 28, day 42
Change in Visceral Sensitivity Index (VSI)
The Visceral Sensitivity Index (VSI) is a validated and reliable psychometric instrument which assesses gastrointestinal symptom-specific anxiety. The VSI contains 15 items that are scored from 0 to 5, therefore the total score can range from 0 to 75. Higher scores indicate more severe gastrointestinal symptom-specific anxiety. Measured after both dietary periods and at baseline of both periods.
Measured: Baseline(day 0), day 14, day 28, day 42
Change in immunological profile of frozen serum samples
Frozen serum samples will be analyzed in the future by immunological testing (e.g. ELISA-kit, assays). The future analyses will include interleukins 6 and 8 (IL-6,8) as well as tumor necrosis factor-alpha (TNF-alpha) and immunological markers such as lipopolysaccharide-binding protein (LBP), sCD14, anti-gliadin antibodies (AGA), fibroblast growth factors, fatty acid-binding protein 2, anti-flagellin immunoglobulin G (IgG) and endotoxin-core antibodies immunoglobulin M (IgM). Analyses will be done on samples from before and after both dietary periods.
Measured: Baseline(day 0), day 14, day 28, day 42
Change in metabolic profile of frozen urine samples
Frozen urine samples will be analyzed in the future by metabolome analysis and urine mass spectrometry. For example the metabolites p-hydroxybenzoic acid, histamine and azelaic acid will be measured. Analyses of samples from before and after both dietary periods. Analyses will be done on samples from before and after both dietary periods.
Measured: Baseline(day 0), day 14, day 28, day 42
Change in microbiota content of frozen fecal samples
Fecal microbiota analysis using 16 S RNA technique and Dysbiosis Test. Analyses will be done on samples from before and after both dietary periods.
Measured: Baseline(day 0), day 14, day 28, day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Oct 2018
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, Double-blind, Placebo-controlled, Cross-over Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magnus Simrén, Sahlgrenska University Hospital
- Investigators
- Magnus Simrén, MD, PhD, Study director, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869359
- Sponsor's protocol ID
- 627-17
- Acronym
- PROT-IBS
- Status last verified
- Oct 2020
- First submitted
- 1 Mar 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Algera JP, Magnusson MK, Ohman L, Storsrud S, Simren M, Tornblom H. Randomised controlled trial: effects of gluten-free diet on symptoms and the gut microenvironment in irritable bowel syndrome. Aliment Pharmacol Ther. 2022 Nov;56(9):1318-1327. doi: 10.1111/apt.17239. Epub 2022 Sep 29.
PubMed 36173041
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gluten in Patients With Irritable Bowel Syndrome and Healthy Volunteers: a Randomized, Placebo-controlled Double-blind Cross-over Trial
- ClinicalTrials.gov ID
- NCT03869359
- Acronym / sponsor ID
- PROT-IBS / 627-17
- Conditions
- Irritable Bowel Syndrome
- Keywords
- gluten-free diet, gluten-containing diet, microbiota, metabolomics, healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 11 Mar 2019 (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.
Patients with Irritable Bowel Syndrome (IBS) often link their symptoms to foods. Interest in dietary management recently increased, including the use of a gluten-free diet.
To investigate relation of gluten-free diet (GFD) and IBS, a randomized, double-blind, placebo-controlled cross-over trial will be carried out in adults (>18) and patients with IBS according to Rome IV criteria. The aim is to assess gluten-free versus gluten-containing diet in IBS patients and Healthy Volunteers.
Detailed description
The study is a randomized, double-blind, placebo-controlled, cross-over trial.
The aim is to assess the effects of gluten-free diet (GFD) compared to gluten-containing diet (GCD) in IBS patients and Healthy Volunteers on gastrointestinal symptoms, visceral sensitivity, bacterial fermentation, psychological factors and quality of life. The primary hypothesis is that GFD decreases gastrointestinal symptoms compared to GCD and that this change is accompanied with reduced visceral sensitivity and change in bacterial fermentation. The secondary hypothesis is that GFD positively influences psychological factors and quality of life.
IBS patients (Rome IV) and Healthy Volunteers are challenged with gluten in this randomized, double-blind, placebo-controlled, cross-over study. They start with GFD or GCD and cross over to the other intervention (both for 14 days). In between there is a wash-out period of at least 14 days. The subjects will get gluten-free meals (lunch and dinner) and have to sprinkle powder over the meals, concealed in sachets with either gluten (vital gluten) or placebo (rice starch). The subjects will follow a strict GFD during the GFD and GCD periods. The subjects will eat and drink as before the study during the washout period.
Primary outcomes are change in gastrointestinal symptoms, assessed by questionnaires, including IBS Severity Scoring System (IBS-SSS) and Gastrointestinal Symtom Rating Scale-IBS (GSRS-IBS). A 50-point reduction in IBS-SSS indicates clinical response. Bacterial fermentation (exhaled hydrogen and methane) and visceral sensitivity will be measured using the Lactulose-Nutrient Challenge Test. Secondary outcomes are change in psychological factors and quality of life assessed by questionnaires, including CSI, HADS, HSPS, IBSQOL, PHQ-15 and VSI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, Double-blind, Placebo-controlled, Cross-over Trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Gluten-free diet with gluten powder, Other: Gluten-free diet with placebo powderGluten-free diet with placebo powder vs Gluten-free diet with gluten powder |
| Group B | Experimental | Other: Gluten-free diet with gluten powder, Other: Gluten-free diet with placebo powderGluten-free diet with gluten powder vs Gluten-free diet with placebo powder |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with IBS according to Rome IV criteria
Key exclusion criteria (8 listed)
- allergy or documented intolerance to food,
- severe cardiovascular, hepatic, neurological or psychiatric disease
- serious gastrointestinal disease: including celiac disease and inflammatory bowel diseases (IBD),
- diabetes
- bowel dysfunction related to previous surgery
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 |
|---|---|---|
| Gluten-free diet with gluten powderThe subjects will sprinkle gluten powder over their meals, twice a day. (14 g/day vital gluten: Real Foods, Edinburgh, United Kingdom). Plastic sachet marked with B (WePack, Derbyshire, United Kingdom). Free of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs). | Other | Group A, Group B |
| Gluten-free diet with placebo powderThe subjects will sprinkle placebo powder over their meals, twice a day. (14 g/day rice starch: Doves Farm Foods Ltd., Berkshire, United Kingdom) Plastic sachets marked with A (WePack, Derbyshire, United Kingdom). Low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs). | Other | Group A, Group B |
Primary outcome
Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS)
Time frame: Baseline(day 0), day 14, day 28, day 42
Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) is a validated questionnaire that incorporates typical IBS symptoms such as abdominal pain, abdominal distension and bowel dysfunction, as well as quality of life. Subjects rated their symptoms on a visual analogue scale. The maximum achievable score is 500 points (sum of the 5 scales). A reduction in the total IBS-SSS score of at least 50 points is considered to indicate a clinically significant improvement in symptoms. The scale can also be used to classify IBS symptoms severity: <75 points (no symptoms), 75-175 points (mild symptoms), 175-300 points (moderate symptoms) and >300 points (severe symptoms). Measured after both dietary periods and at baseline of both periods.
Change in Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRS-IBS)
Time frame: Baseline(day 0), day 14, day 28, day 42
Change in Gastrointestinal Symptom Rating Scale - Irritable Bowel Syndrome (GSRS-IBS) measures symptom severity and symptom frequency in IBS patients and is a reliable and validated questionnaire. Thirteen questions are evaluated and rated from 1 (no discomfort at all) to 7 (very severe discomfort) on a Likert scale. The total scores can range from 13 to 91 (sum of the domains). The GSRS-IBS evaluates 5 domains: abdominal pain, bloating, constipation, diarrhea and satiety. Measured after both dietary periods and at baseline of both periods.
Change in stool frequency, measured by Bristol Stool Form (BSF)
Time frame: Day 14, Day 42
Change in Bristol Stool Form, stool frequency per day after both dietary periods
Change in Visceral Sensitivity and Bacterial Fermentation
Time frame: Baseline(day 0), day 14, day 28, day 42
Visceral Sensitivity and Bacterial Fermentation measured by the Lactulose-Nutrient Challenge Test.
9 secondary outcomes
Change in Central Sensitization Inventory (CSI) score
Time frame: Baseline(day 0), day 14, day 28, day 42
Change in Hospital Anxiety and Depression Scale (HADS) score
Time frame: Baseline(day 0), day 14, day 28, day 42
Change in Highly Sensitive Person Scale (HSPS)
Time frame: Baseline(day 0), day 14, day 28, day 42
Change in Irritable Bowel Syndrome Quality of Life Questionnaire (IBSQOL)
Time frame: Baseline(day 0), day 14, day 28, day 42
Change in Patient health questionnaire-15 (PHQ-15)
Time frame: Baseline(day 0), day 14, day 28, day 42
Change in Visceral Sensitivity Index (VSI)
Time frame: Baseline(day 0), day 14, day 28, day 42
Change in immunological profile of frozen serum samples
Time frame: Baseline(day 0), day 14, day 28, day 42
Change in metabolic profile of frozen urine samples
Time frame: Baseline(day 0), day 14, day 28, day 42
Change in microbiota content of frozen fecal samples
Time frame: Baseline(day 0), day 14, day 28, day 42
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 22 Oct 2020.
- Derived from this study: PubMed 36173041Algera JP, Magnusson MK, Ohman L, Storsrud S, Simren M, Tornblom H. Randomised controlled trial: effects of gluten-free diet on symptoms and the gut microenvironment in irritable bowel syndrome. Aliment Pharmacol Ther. 2022 Nov;56(9):1318-1327. doi: 10.1111/apt.17239. Epub 2022 Sep 29.
- Individual participant dataSharing planned: Undecided
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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.
Magnus Simrén, MD, PhD study director
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten-free diet with gluten powder in people with Irritable Bowel Syndrome, run by Sahlgrenska University Hospital 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 8 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 22 Oct 2020. 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?
Change in Irritable Bowel Syndrome-Severity Scoring System (IBS-SSS) (time frame: Baseline(day 0), day 14, day 28, day 42). 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 NCT03869359, which also lists 1 linked publication.
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 22 Oct 2020.