IBS - Irritable Bowel SyndromeLeguComfNCT05118243
Innovative Tools to Produce Legume-based Foods for Increased Consumer Acceptance
A study testing Enzyme-treated cracker in people with IBS - Irritable Bowel Syndrome, run by University of Helsinki at 1 site in Finland.
Trial summary
The aim of this study is to investigate the effects of enzymatic treatment to reduce GOS (galactooligosaccharides) in legume-based crackers in IBS (irritable bowel syndrome) persons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Enzyme-treated cracker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 6 Sep 2021to Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS (Rome IV criteria) or functional bloating
- over 18 years old
Who cannot join
- IBD (inflammatory bowel disease)
- coeliac disease
- pregnancy or breastfeeding
- antibiotics within the last 3 months
- colonoscopy and preparations for it within 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the effects of enzymatic treatment to reduce GOS (galactooligosaccharides) in legume-based crackers in IBS (irritable bowel syndrome) persons. The crackers are pea-based: the control crackers contain high amounts of GOS, while the enzymatically treated crackers contain a minimal amount of GOS. The participants will eat each type of cracker for three days (daily dose of 12 crackers) and report their gut symptoms (e.g. flatulence, stomach pain, bloating) by using a mobile app. There is a washout period of four days between the different crackers. In addition, the participants will keep food records on the cracker eating days as well as collect five fecal samples during the study. The participants will also report their physical activity and the number of defecations on each day. The study is carried out in a double-blinded crossover setting.
Read the detailed description
A human intervention study with volunteers suffering from either irritable bowel syndrome (IBS) or functional bloating (FB) will be carried out to investigate the effects of enzymatic treatment of pea-based product on gastrointestinal symptoms and gut microbiota composition as well as hydrogen production due to carbohydrate fermentation. Enzyme-treated product will be compared to a control product.
The aim of the study is to investigate, whether enzyme-treated cracker, compared to a control product, will reduce gastrointestinaI symptoms, or have an impact on fecal microbiome or carbohydrate fermentation measured by breath hydrogen concentration. The effects of eating enzyme-treated crackers on food intake, exercise and stool frequency will also be investigated.
The study is carried out in a randomized, double-blinded, placebo-controlled crossover design. The study includes two 1-week treatment periods with 1-week run-in period before the intervention. Participants (N=35 at the maximum) are adult males and females who meet Rome IV criteria for IBS or FB.
Exclusion criteria will be as follows:
- coeliac disease
- inflammatory bowel disease
- pregnancy or breastfeeding
- antibiotics within the last 3 months
- colonoscopy and preparations for it within 4 weeks
During both treatment weeks each participant will receive three-day portion of either α-galactosidase-treated or control pea-based crackers. The participants will be advised to avoid foods that trigger their gastrointestinaI symptoms and otherwise follow their habitual diets for the whole 3-week study period. They will be asked to report severity of nine gastrointestinaI symptoms, keep food record, collect fecal samples, measure breath hydrogen and report their physical activity as well as stool frequency.
The participants will report their gastrointestinal symptoms throughout the study weeks (twice a day on cracker eating days, once on washout days). Physical activity and stool frequency will also be reported daily. Fecal samples will be collected during the run-in period (at baseline) and on third and seventh day of each treatment week. Breath hydrogen will be measured on second day of both treatment weeks. Nutrient intake and food consumption will be analyzed from 3-day food records during the run-in week and each treatment week (total 9 days). Nutrient intake will be calculated using a new Finnish 'Aromi Diet' software.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Control cracker, Enzyme-treated cracker
- 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.
Control crackerOther
The gut symptoms caused by control crackers are studied in IBS persons
Enzyme-treated crackerOther
The gut symptoms caused by enzyme-treated crackers are studied in IBS persons
| Study group | Role | What they receive |
|---|---|---|
| Control cracker | Active comparator | All participants eat control crackers, which contain high amounts of GOS (approx. 5g GOS/daily portion of crackers) Receives: Other: Control cracker |
| Enzyme-treated cracker | Active comparator | All participants eat enzyme-treated crackers, which contain minimal amounts of GOS (less than 1g GOS/daily portion of crackers) Receives: Other: Enzyme-treated cracker |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intensity of stomach pain measured by a visual analogue scale
Study participants report the intensity of experienced stomach pain on a scale of zero (no pain at all) to 100 (very intense pain) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
Measured: 2 weeks
The intensity of stomach cramps measured by a visual analogue scale
Study participants report the intensity of experienced stomach cramps on a scale of zero (no cramps at all) to 100 (very intense cramps) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
Measured: 2 weeks
The intensity of bloating measured by a visual analogue scale
Study participants report the intensity of experienced bloating on a scale of zero (no bloating) to 100 (very bloated) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
Measured: 2 weeks
The intensity of flatulence measured by a visual analogue scale
Study participants report the intensity of experienced flatulence on a scale of zero (no flatulence at all) to 100 (very intense flatulence) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
Measured: 2 weeks
The intensity of stomach noise measured by a visual analogue scale
Study participants report the intensity of experienced stomach noise on a scale of zero (no noise at all) to 100 (very loud noise) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
Measured: 2 weeks
The intensity of nausea measured by a visual analogue scale
Study participants report the intensity of experienced nausea on a scale of zero (no nausea at all) to 100 (very intense nausea) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
Measured: 2 weeks
The intensity of heartburn measured by a visual analogue scale
Study participants report the intensity of experienced heartburn on a scale of zero (no heartburn at all) to 100 (very intense heartburn) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
Measured: 2 weeks
The intensity of an unpleasant feeling in the upper abdomen or the feeling of feeling full fast related to eating measured by a visual analogue scale
Study participants report the intensity of an unpleasant feeling in the upper abdomen or the feeling of feeling full fast related to eating on a scale of zero (no no described unpleasant feeling at all) to 100 (very intense unpleasant feeling) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
Measured: 2 weeks
The intensity of a sudden need to defecate measured by a visual analogue scale
Study participants report the intensity of a sudden need to defecate on a scale of zero (no need to defecate at all) to 100 (very intense need to defecate) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
Measured: 2 weeks
The composition of gut microbiota analyzed from fecal samples using 16S rRNA amplicon sequencing
The composition of gut microbiota is analyzed from fecal samples using 16S rRNA amplicon sequencing and qPCR (quantitative polymerase chain reaction). The differences between the treatments will be analyzed statistically.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start6 Sep 2021
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Maria Pajari, University of Helsinki
- Investigators
- Anne-Maria Pajari, Principal investigator, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118243
- Sponsor's protocol ID
- LeguComf-HY
- Acronym
- LeguComf
- Status last verified
- May 2022
- First submitted
- 8 Oct 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data cannot be shared
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Tools to Produce Legume-based Foods for Increased Consumer Acceptance
- ClinicalTrials.gov ID
- NCT05118243
- Acronym / sponsor ID
- LeguComf / LeguComf-HY
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Nov 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.
The aim of this study is to investigate the effects of enzymatic treatment to reduce GOS (galactooligosaccharides) in legume-based crackers in IBS (irritable bowel syndrome) persons. The crackers are pea-based: the control crackers contain high amounts of GOS, while the enzymatically treated crackers contain a minimal amount of GOS. The participants will eat each type of cracker for three days (daily dose of 12 crackers) and report their gut symptoms (e.g. flatulence, stomach pain, bloating) by using a mobile app. There is a washout period of four days between the different crackers. In addition, the participants will keep food records on the cracker eating days as well as collect five fecal samples during the study. The participants will also report their physical activity and the number of defecations on each day. The study is carried out in a double-blinded crossover setting.
Detailed description
A human intervention study with volunteers suffering from either irritable bowel syndrome (IBS) or functional bloating (FB) will be carried out to investigate the effects of enzymatic treatment of pea-based product on gastrointestinal symptoms and gut microbiota composition as well as hydrogen production due to carbohydrate fermentation. Enzyme-treated product will be compared to a control product.
The aim of the study is to investigate, whether enzyme-treated cracker, compared to a control product, will reduce gastrointestinaI symptoms, or have an impact on fecal microbiome or carbohydrate fermentation measured by breath hydrogen concentration. The effects of eating enzyme-treated crackers on food intake, exercise and stool frequency will also be investigated.
The study is carried out in a randomized, double-blinded, placebo-controlled crossover design. The study includes two 1-week treatment periods with 1-week run-in period before the intervention. Participants (N=35 at the maximum) are adult males and females who meet Rome IV criteria for IBS or FB.
Exclusion criteria will be as follows:
- coeliac disease
- inflammatory bowel disease
- pregnancy or breastfeeding
- antibiotics within the last 3 months
- colonoscopy and preparations for it within 4 weeks
During both treatment weeks each participant will receive three-day portion of either α-galactosidase-treated or control pea-based crackers. The participants will be advised to avoid foods that trigger their gastrointestinaI symptoms and otherwise follow their habitual diets for the whole 3-week study period. They will be asked to report severity of nine gastrointestinaI symptoms, keep food record, collect fecal samples, measure breath hydrogen and report their physical activity as well as stool frequency.
The participants will report their gastrointestinal symptoms throughout the study weeks (twice a day on cracker eating days, once on washout days). Physical activity and stool frequency will also be reported daily. Fecal samples will be collected during the run-in period (at baseline) and on third and seventh day of each treatment week. Breath hydrogen will be measured on second day of both treatment weeks. Nutrient intake and food consumption will be analyzed from 3-day food records during the run-in week and each treatment week (total 9 days). Nutrient intake will be calculated using a new Finnish 'Aromi Diet' software.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control cracker | Active comparator | Other: Control crackerAll participants eat control crackers, which contain high amounts of GOS (approx. 5g GOS/daily portion of crackers) |
| Enzyme-treated cracker | Active comparator | Other: Enzyme-treated crackerAll participants eat enzyme-treated crackers, which contain minimal amounts of GOS (less than 1g GOS/daily portion of crackers) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IBS (Rome IV criteria) or functional bloating
- over 18 years old
Key exclusion criteria (5 listed)
- IBD (inflammatory bowel disease)
- coeliac disease
- pregnancy or breastfeeding
- antibiotics within the last 3 months
- colonoscopy and preparations for it within 4 weeks
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 |
|---|---|---|
| Control crackerThe gut symptoms caused by control crackers are studied in IBS persons | Other | Control cracker |
| Enzyme-treated crackerThe gut symptoms caused by enzyme-treated crackers are studied in IBS persons | Other | Enzyme-treated cracker |
Primary outcome
The intensity of stomach pain measured by a visual analogue scale
Time frame: 2 weeks
Study participants report the intensity of experienced stomach pain on a scale of zero (no pain at all) to 100 (very intense pain) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of stomach cramps measured by a visual analogue scale
Time frame: 2 weeks
Study participants report the intensity of experienced stomach cramps on a scale of zero (no cramps at all) to 100 (very intense cramps) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of bloating measured by a visual analogue scale
Time frame: 2 weeks
Study participants report the intensity of experienced bloating on a scale of zero (no bloating) to 100 (very bloated) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of flatulence measured by a visual analogue scale
Time frame: 2 weeks
Study participants report the intensity of experienced flatulence on a scale of zero (no flatulence at all) to 100 (very intense flatulence) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of stomach noise measured by a visual analogue scale
Time frame: 2 weeks
Study participants report the intensity of experienced stomach noise on a scale of zero (no noise at all) to 100 (very loud noise) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of nausea measured by a visual analogue scale
Time frame: 2 weeks
Study participants report the intensity of experienced nausea on a scale of zero (no nausea at all) to 100 (very intense nausea) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of heartburn measured by a visual analogue scale
Time frame: 2 weeks
Study participants report the intensity of experienced heartburn on a scale of zero (no heartburn at all) to 100 (very intense heartburn) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of an unpleasant feeling in the upper abdomen or the feeling of feeling full fast related to eating measured by a visual analogue scale
Time frame: 2 weeks
Study participants report the intensity of an unpleasant feeling in the upper abdomen or the feeling of feeling full fast related to eating on a scale of zero (no no described unpleasant feeling at all) to 100 (very intense unpleasant feeling) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The intensity of a sudden need to defecate measured by a visual analogue scale
Time frame: 2 weeks
Study participants report the intensity of a sudden need to defecate on a scale of zero (no need to defecate at all) to 100 (very intense need to defecate) using a mobile application. The data will be summarized in Excel form and the differences between the treatments will be analyzed statistically.
The composition of gut microbiota analyzed from fecal samples using 16S rRNA amplicon sequencing
Time frame: 2 weeks
The composition of gut microbiota is analyzed from fecal samples using 16S rRNA amplicon sequencing and qPCR (quantitative polymerase chain reaction). The differences between the treatments will be analyzed statistically.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No. Data cannot be shared
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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.
Anne-Maria Pajari principal investigator
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enzyme-treated cracker in people with IBS - Irritable Bowel Syndrome, run by University of Helsinki at 1 site in Finland.
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 5 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: status not confirmed, as of the sponsor's last update on 18 May 2022. 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 Finland. 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?
Results are not available in the source record.
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?
The intensity of stomach pain measured by a visual analogue scale (time frame: 2 weeks). The study lists 10 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 18 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.