Sucrase-isomaltase Deficiency as a Cause of Irritable Bowel Syndrome

NCT05159115 | Not Yet Recruiting

• 1 other identifier: MED 358
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Irritable bowel syndrome (IBS) is a functional disorder causing troublesome symptoms and reduced quality of life. It affects 10-20% of the population, hence creates large costs for society. About 30-40% of all IBS patients do not benefit from current treatment options. Sucrase-isomaltase (SI) deficiency is an unexplored condition, that may explain symptoms in IBS patients who experience no effect from today's treatments. Currently, a duodenal biopsy is the gold standard for the diagnosis of SI deficiency, however the condition is not well investigated. A 13C-labelled breath test holds promise as a non-invasive alternative, but it has not previously been validated. This project will address the knowledge gap related to a possible association between SI deficiency and IBS by addressing two research questions that have never been answered before. We aim to:

1. 1.Validate the 13C-labelled breath test as a diagnostic tool by assessing the strength of the association between the breath test and SI activity measured in duodenal biopsies
2. 2.Use the 13C-labelled breath test in a randomized dietary crossover trial comparing a starch and sucrose reduced diet (SSRD) with the standard low-FODMAP diet in IBS patients, to evaluate whether SI activity is associated with dietary changes according to symptom severity and gut microbiota composition

Conditions

Irritable Bowel Syndrome; Sucrose Intolerance Due to Sucrase-Isomaltase Deficiency; Carbohydrate; Malabsorption; Sucrase Isomaltase Deficiency; Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (1)

• IBS symptom severity

  Symptom severity measured by the IBS-Symptom Severity Scale (IBS-SSS)

  4 weeks

Secondary Outcomes (3)

• Gut microbiota composition

  4 weeks

• Fecal fermentation measured by short chain fatty acids (SCFAs)

  4 weeks

• Quality of life in IBS

  4 weeks

Study Arms (2)

Low-FODMAP diet

ACTIVE COMPARATOR

Patients with IBS on a 4-week low-FODMAP diet.

Other: Low-FODMAP diet

Starch- and Sucrose Reduced Diet

EXPERIMENTAL

Patients with IBS on a s 4-week Starch- and Sucrose Reduced Diet (SSRD).

Other: Starch- and Sucrose Reduced Diet (SSRD)

Interventions

Low-FODMAP diet OTHER

4 weeks of a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs)

Low-FODMAP diet

Starch- and Sucrose Reduced Diet (SSRD) OTHER

4 weeks of a diet low in starch and sucrose

Starch- and Sucrose Reduced Diet

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• BMI 18-30 kg/m2
• Referred for gastroscopic examination with suspected GI disorder

You may not qualify if:

• Unwilling or not capable of signing the informed consent
• Sucrase-isomaltase deficiency as a cause of symptoms in patients with irritable bowel syndrome (n=80)
• Signed informed consent
• BMI 18-30 kg/m2
• IBS diagnosis according to Rome IV criteria
• Inflammatory bowel disease, celiac disease or diabetes mellitus
• Chronic immune diseases affecting the GI-system
• Unwilling/unable to maintain a stable diet throughout the study period
• Use of antibiotic treatment for the last 4 weeks
• Currently on a restrictive diet

Sponsors & Collaborators

• Lovisenberg Diakonale Hospital: lead
• University of Bergen: collaborator

MeSH Terms

Conditions

Irritable Bowel Syndrome; Malabsorption Syndromes; Sucrase-isomaltase deficiency, congenital; Gastrointestinal Diseases

Interventions

FODMAP Diet; Starch

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Central Study Contacts

Jørgen Valeur, PhD

CONTACT

0047 23225140; jorgen.valeur@lds.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 15, 2021
• Study Start: March 14, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 2, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share