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The Effects of Carbohydrates in Irritable Bowel Syndrome (FIBS)

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ClinicalTrials.gov Identifier: NCT04830410
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : April 5, 2021
Sponsor:
Collaborators:
Atmo Biosciences
Beneo-Institute
Information provided by (Responsible Party):
Magnus Simrén, Sahlgrenska University Hospital, Sweden

Brief 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.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome With Diarrhea Dietary Supplement: Fructan reintroduction Dietary Supplement: Placebo reintroduction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: After a low FODMAP diet, patients will have to reintroduce fructan or placebo powder. Patients will be randomized by a web-mail randomization.The powder bags were prepared and named A or B by the firms Beneo, and the participants and the staff involved in the study will be blinded.
Primary Purpose: Treatment
Official Title: The Effects of Fructans in Irritable Bowel Syndrome
Estimated Study Start Date : March 30, 2021
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. visceral sensitivity [ Time Frame: Baseline ]
    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

  2. change in intestinal gas production [ Time Frame: between baseline and after (7days +/-3 days) of reintroduction ]
    measured by a gas sensing capsule (Atmo), between the 2 groups

  3. change in gas production [ Time Frame: between baseline and after (7days +/-3 days) of reintroduction ]
    measured by breath tests (H2 and CH4) between the 2 groups.

  4. change in microbiota [ Time Frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days) ]
    Fecal microbiota analysis using 16S technique between the 2 groups.

  5. Change in metabolomics profiles [ Time Frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days) ]
    Targeted and untargeted metabolomics in urine, blood and stool samples measured by Liquid and gas chromatography-mass spectrometry between the 2 groups.

  6. change in stool form and frequency [ Time Frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days) ]
    Stool diary between the 2 groups.

  7. GSRS-IBS [ Time Frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days) ]
    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.

  8. HAD [ Time Frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days) ]
    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.

  9. VSI [ Time Frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days) ]
    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).

  10. IBSQOL [ Time Frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days) ]
    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.

  11. PHQ12 [ Time Frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days) ]
    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.

  12. CSI [ Time Frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days) ]
    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.

  13. IBS-SSS [ Time Frame: between baseline, after the low FODMAP diet (14 days) and after reintroduction (7+/-3 days) ]
    change in irritable bowel syndrome severity scoring system (IBS-SSS) between the 2 groups.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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…)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04830410


Contacts
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Contact: Magnus Simrén, MD, PhD +46313421000 magnus.simren@medicine.gu.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Göteborg, Sweden
Contact: Magnus Simrén, MD, PhD    +46313421000    magnus.simren@medicine.gu.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Atmo Biosciences
Beneo-Institute
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Responsible Party: Magnus Simrén, Professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04830410    
Other Study ID Numbers: FIBS 2020-03644
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Magnus Simrén, Sahlgrenska University Hospital, Sweden:
Fructans
FODMAP
carbohydrates
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Diarrhea
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Levan
Antineoplastic Agents