The Effects of Carbohydrates in Irritable Bowel Syndrome (FIBS)

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.

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 Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome With Diarrhea
• Intervention / Treatment: Dietary supplement: Fructan reintroduction; Dietary supplement: Placebo reintroduction

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• IBS according to ROME IV criteria (with diarrhoea)

Exclusion Criteria:

• 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.
• 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…)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fructan powder; 2 g of fructan powder 3 times per day for 7 days	Dietary supplement: Fructan reintroduction; Patients will reintroduce fructan powder after 14-day of a low FODMAP diet
Placebo Comparator: Placebo; 2g of placebo (maltodextrin) 3 times per day for 7 days.	Dietary supplement: Placebo reintroduction; Patients will reintroduce placebo powder after 14-day of a low FODMAP diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	before and after the reintroduction (7days +/-3 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline
change in intestinal gas production	measured by a gas sensing capsule (Atmo), between the 2 groups	between baseline and after (7days +/-3 days) of reintroduction
change in gas production	measured by breath tests (H2 and CH4) between the 2 groups.	between baseline and after (7days +/-3 days) of reintroduction
change in microbiota	Fecal microbiota analysis using 16S technique between the 2 groups.	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.	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.	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.	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.	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).	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.	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.	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.	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.	between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days)

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital
• Collaborators: Beneo-Institute; Atmo Biosciences Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Actual): June 2, 2025
• Study Completion (Actual): June 2, 2025

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: carbohydrates; FODMAP; Fructans
• Additional Relevant MeSH Terms: Pathologic Processes; Signs and Symptoms, Digestive; Intestinal Diseases; Disease; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome; Syndrome; Diarrhea; Antineoplastic Agents; Levan
• Other Study ID Numbers: FIBS 2020-03644

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No