The Effects of Carbohydrates in Irritable Bowel Syndrome

Irritable Bowel Syndrome With Diarrhea Clinical Trial

— FIBS  

Official title:

The Effects of Fructans in Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04830410
• Other study ID #: FIBS 2020-03644
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2021
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: Magnus Simrén, MD, PhD
• Phone: +46313421000
• Email: magnus.simren[@]medicine.gu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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…)

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

Dietary Supplement:
• Fructan reintroduction
Patients will reintroduce fructan powder after 14-day of a low FODMAP diet
• Placebo reintroduction
Patients will reintroduce placebo powder after 14-day of a low FODMAP diet

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (3)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Atmo Biosciences Pty Ltd, Beneo-Institute

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	change in gas production	measured by breath tests (H2 and CH4) between the 2 groups.	between baseline and after (7days +/-3 days) of reintroduction
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)