Irritable Bowel Syndrome With DiarrheaFIBSNCT04830410
The Effects of Carbohydrates in Irritable Bowel Syndrome
A study testing Fructan reintroduction in people with Irritable Bowel Syndrome With Diarrhea, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Food and their components are often reported as gastrointestinal (GI) symptom triggers in patients with IBS. The current interest in dietary management in IBS, has largely focused on the negative effect of poorly absorbed and subsequently fermented carbohydrates (FODMAP - Fermentable Oligo-, Di-, Mono-saccharides And… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Fructan reintroduction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteSweden
- Study dates
- 30 Mar 2021to 2 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- IBS according to ROME IV criteria (with diarrhoea)
Who cannot join
- Celiac disease or any other gastroenterology disease (such as inflammatory bowel disease, celiac disease, microscopic colitis, diverticulitis, radiation enteritis).
- Suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastric bezoar.
- Appendicectomy and cholecystectomy <3 months.
- Heart-, liver-, neurological-, or current psychiatric disease, diabetes, obesity (BMI>30), other disease or surgery to the abdomen that affected intestinal function.
- Implantable or portable electro-mechanical medical devices, e.g. pacemakers.
- Swallowing disorders/dysphagia to food or pills.
Show all 13Show fewer
- Allergy or intolerances to foods.
- Compliance to a special diet (including vegan, vegetarian, gluten-free or low FODMAP diet).
- Pregnant or breast feeding.
- Usage of antibiotics within 4 weeks prior to inclusion
- Usage of alcohol more than 14 units per week.
- No new pharmacological treatment during the study period.
- Medications: laxatives, neuromodulators or opioids (morphine, codeine, tramadol…)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Fructans in Irritable Bowel Syndrome
Food and their components are often reported as gastrointestinal (GI) symptom triggers in patients with IBS. The current interest in dietary management in IBS, has largely focused on the negative effect of poorly absorbed and subsequently fermented carbohydrates (FODMAP - Fermentable Oligo-, Di-, Mono-saccharides And Polyols). These unabsorbed carbohydrates can generate GI symptoms through osmosis, with increased amount of fluid in the gut lumen, and via modification of gut microbiota composition and function (fermentation and production of gas).
Studies assessing diets low in FODMAPs have shown promising results in symptom improvement in some IBS patients, but not in all. The low FODMAP diet, as it is used today, is restrictive and difficult for patients to accommodate in their daily life. Moreover, the effect of this diet on microbiota composition and function is not defined, and there are also concerns that restrictive diets may lead to nutritional inadequacy.
Read more
Fructan is a specific FODMAP which is built of fructose polymers. Examples of foods that contain fructans are wheat, onion, garlic and banana. The daily dietary intake of fructans varies approximately between 3 and 6 grams. Fructans are potential triggers of GI symptoms in IBS however, they are currently also used as prebiotic supplements. A recent systematic review and meta-analysis concluded that low dosages of fructans do not worsen GI symptoms, but they do increase the beneficial bifidobacteria. It remains unclear whether the potential benefits of fructans outweigh the potential harmful effects in patients with IBS.
The investigators are aiming to assess the effects of fructans, as well as predictive factors and mechanisms involved, and to compare with placebo in IBS patients. The investigators will assess GI symptom severity, visceral sensitivity, intestinal gas production, gut immunity and microbiota, and metabolites produced in the gut.
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- Fructan reintroduction, Placebo reintroduction
- Keywords
- Fructans, FODMAP, carbohydrates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fructan reintroductionDietary supplement
Patients will reintroduce fructan powder after 14-day of a low FODMAP diet
Placebo reintroductionDietary supplement
Patients will reintroduce placebo powder after 14-day of a low FODMAP diet
| Study group | Role | What they receive |
|---|---|---|
| Fructan powder | Experimental | 2 g of fructan powder 3 times per day for 7 days Receives: Dietary Supplement: Fructan reintroduction |
| Placebo | Placebo comparator | 2g of placebo (maltodextrin) 3 times per day for 7 days. Receives: Dietary Supplement: Placebo reintroduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS-SSS
change in irritable bowel syndrome severity scoring system (IBS-SSS) between the 2 groups. IBS-SSS is between 0 and 500, with a higher score meaning more severe symptoms.
Measured: before and after the reintroduction (7days +/-3 days)
Secondary outcomes (13)
visceral sensitivity
measured by a rectal barostat, predictor for a better GI response to a low FODMAP diet and predictor of a worse GI response to fructan reintroduction
Measured: Baseline
change in intestinal gas production
measured by a gas sensing capsule (Atmo), between the 2 groups
Measured: between baseline and after (7days +/-3 days) of reintroduction
change in gas production
measured by breath tests (H2 and CH4) between the 2 groups.
Measured: between baseline and after (7days +/-3 days) of reintroduction
change in microbiota
Fecal microbiota analysis using 16S technique between the 2 groups.
Measured: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
Change in metabolomics profiles
Targeted and untargeted metabolomics in urine, blood and stool samples measured by Liquid and gas chromatography-mass spectrometry between the 2 groups.
Measured: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
change in stool form and frequency
Stool diary between the 2 groups.
Measured: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
GSRS-IBS
change in Gastrointestinal symptom rating scale-IBS (GSRS-IBS) between the 2 groups. GSRS-IBS assesses five GI symptom domains: satiety, abdominal pain, diarrhea, constipation and bloating. The five domains are calculated using the mean of two to four items scored with 7-point Likert scales, with higher scores representing more severe symptoms.
Measured: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
HAD
change in Hospital Anxiety and depression scale (HAD) between the 2 groups. HAD assesses the severity of psychological distress, i.e. anxiety and depression. In this 14-item scale, seven items measure anxiety and the other seven measure depression on a 4-point Likert scale (0-3) which provides a score between 0 (absence) and 21 (high level). Scores higher than 10 on each of the subscales is considered to define clinically relevant anxiety and/or depression.
Measured: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
VSI
change in Visceral sensitivity index (VSI) between the 2 groups. VSI is a 15-item validated scale measuring GI symptom-specific anxiety, i.e. the cognitive, affective, and behavioural response to fear of GI sensations, symptoms, and the context in which these occur. The total score ranges between 0 (no GI-specific anxiety) to 75 (severe GI-specific anxiety).
Measured: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
IBSQOL
change in irritable bowel syndrome quality of life (IBSQOL) questionnaire between the 2 groups. IBSQOL is a disease-specific, self-administered questionnaire, with 30 items measuring nine aspects of health-related quality of life during the past four weeks. The nine domains are emotional health, mental health, sleep, energy, physical functioning, food/diet, social role, physical role and sexual relations. Each question has five or six response options. For each subscale, the score is transformed to a 0-100 scale. A higher score represents a better quality of life.
Measured: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
PHQ12
change in patient health questionnaire 12 (PHQ12) between the 2 groups. The PHQ-15 is a somatic symptom subscale derived from the full PHQ. It inquires about 15 somatic symptoms; each individual symptom is coded as 0, 1, or 2, and the total score ranges from 0 to 30, with higher scores representing more severe symptoms.
Measured: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
CSI
change in Central Sensitization Inventory (CSI) between the 2 groups. The responses were graded on a Likert scale from 0 (never) to 4 (always). The total score ranges from 0 to 100. A higher score suggest higher central sensitization syndrome.
Measured: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
IBS-SSS
change in irritable bowel syndrome severity scoring system (IBS-SSS) between the 2 groups.
Measured: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start30 Mar 2021
- Primary completion2 Jun 2025
- Study completion2 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Atmo Biosciences Pty Ltd, Beneo-Institute
- Responsible party
- Principal investigator, Magnus Simrén, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830410
- Sponsor's protocol ID
- FIBS 2020-03644
- Acronym
- FIBS
- Status last verified
- Nov 2025
- First submitted
- 26 Mar 2021
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fructans in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04830410
- Acronym / sponsor ID
- FIBS / FIBS 2020-03644
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Keywords
- Fructans, FODMAP, carbohydrates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Atmo Biosciences Pty Ltd, Beneo-Institute
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 2 Jun 2025 (actual)
- First posted
- 5 Apr 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.
Food and their components are often reported as gastrointestinal (GI) symptom triggers in patients with IBS. The current interest in dietary management in IBS, has largely focused on the negative effect of poorly absorbed and subsequently fermented carbohydrates (FODMAP - Fermentable Oligo-, Di-, Mono-saccharides And Polyols). These unabsorbed carbohydrates can generate GI symptoms through osmosis, with increased amount of fluid in the gut lumen, and via modification of gut microbiota composition and function (fermentation and production of gas).
Studies assessing diets low in FODMAPs have shown promising results in symptom improvement in some IBS patients, but not in all. The low FODMAP diet, as it is used today, is restrictive and difficult for patients to accommodate in their daily life. Moreover, the effect of this diet on microbiota composition and function is not defined, and there are also concerns that restrictive diets may lead to nutritional inadequacy.
Fructan is a specific FODMAP which is built of fructose polymers. Examples of foods that contain fructans are wheat, onion, garlic and banana. The daily dietary intake of fructans varies approximately between 3 and 6 grams. Fructans are potential triggers of GI symptoms in IBS however, they are currently also used as prebiotic supplements. A recent systematic review and meta-analysis concluded that low dosages of fructans do not worsen GI symptoms, but they do increase the beneficial bifidobacteria. It remains unclear whether the potential benefits of fructans outweigh the potential harmful effects in patients with IBS.
The investigators are aiming to assess the effects of fructans, as well as predictive factors and mechanisms involved, and to compare with placebo in IBS patients. The investigators will assess GI symptom severity, visceral sensitivity, intestinal gas production, gut immunity and microbiota, and metabolites produced in the gut.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fructan powder | Experimental | Dietary Supplement: Fructan reintroduction2 g of fructan powder 3 times per day for 7 days |
| Placebo | Placebo comparator | Dietary Supplement: Placebo reintroduction2g of placebo (maltodextrin) 3 times per day for 7 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- IBS according to ROME IV criteria (with diarrhoea)
Key exclusion criteria (13 listed)
- Celiac disease or any other gastroenterology disease (such as inflammatory bowel disease, celiac disease, microscopic colitis, diverticulitis, radiation enteritis).
- Suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastric bezoar.
- Appendicectomy and cholecystectomy <3 months.
- Heart-, liver-, neurological-, or current psychiatric disease, diabetes, obesity (BMI>30), other disease or surgery to the abdomen that affected intestinal function.
- Implantable or portable electro-mechanical medical devices, e.g. pacemakers.
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 |
|---|---|---|
| Fructan reintroductionPatients will reintroduce fructan powder after 14-day of a low FODMAP diet | Dietary supplement | Fructan powder |
| Placebo reintroductionPatients will reintroduce placebo powder after 14-day of a low FODMAP diet | Dietary supplement | Placebo |
Primary outcome
IBS-SSS
Time frame: before and after the reintroduction (7days +/-3 days)
change in irritable bowel syndrome severity scoring system (IBS-SSS) between the 2 groups. IBS-SSS is between 0 and 500, with a higher score meaning more severe symptoms.
13 secondary outcomes
visceral sensitivity
Time frame: Baseline
change in intestinal gas production
Time frame: between baseline and after (7days +/-3 days) of reintroduction
change in gas production
Time frame: between baseline and after (7days +/-3 days) of reintroduction
change in microbiota
Time frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
Change in metabolomics profiles
Time frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
change in stool form and frequency
Time frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
GSRS-IBS
Time frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
HAD
Time frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
VSI
Time frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
IBSQOL
Time frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
PHQ12
Time frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
CSI
Time frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
IBS-SSS
Time frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)
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 24 Nov 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fructan reintroduction in people with Irritable Bowel Syndrome With Diarrhea, 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 13 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 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
IBS-SSS (time frame: before and after the reintroduction (7days +/-3 days)). 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 24 Nov 2025.