Sucrase-Isomaltase (SI) Genes and Meal Load

NCT07309601 | Recruiting

• 1 other identifier: 2025-07563-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to examine whether those patients with irritable bowel syndrome (IBS) and a reduced abitility do degrade starch and sugar (lowe levels of enzymes) have lower raise in blood glucose after a meal than those with normal expression of enzymes. We also want to examine whether those IBS patients with reduced enzyme levels have increased bowel symptom in relation to this meal. The main questions it aims to answer are: Does reduced ability to degrade starch and sugar due to less enzyme activity lead to lower increase in blood glucose after a meal? Does reduced ability to degrade starch and sugar due to less enzyme activity lead to increased bowel symptoms after a meal?

Conditions

Sucrase-Isomaltase Deficiency; IBS - Irritable Bowel Syndrome

Keywords

IBS; SI genes; Starch and sucrose; blood glucose levels; bowel symptoms

Outcome Measures

Primary Outcomes (1)

• Changes of blood glucose after a meal intake

  We will measure blood glucose levels in plasma through a plastic tube. Two samples will be collected before the meal start. One sample 10 minutes before the meal intake and one immediately prior the meal intake. The meal consists of a sugar-rich breakfast, which must be ingested within 15 minutes. Blood samples will then be collected at 10, 20, 30, 45, 60, 90, and 120 minutes afterwards. Blood glucose will be measured at the Department of Clinical Chemistry at the hospital, according to clinical routines.

  2 hours

Secondary Outcomes (1)

• Changes of gastrointestinal and extraintestinal symptoms after a meal intake assesssed by self-reported completion on visual analog scales

  2 hours

Study Arms (1)

Meal intake

EXPERIMENTAL

Dietary Supplement: Meal load

Interventions

Meal load DIETARY_SUPPLEMENT

Meal load during 15 minutes

Meal intake

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of irritable bowel syndrome (IBS)
• Gene testing has been conducted regarding genes regulating the production of sucrase-isomaltase ensymes in previous dietary interventions using the starch- and sucrose reduced diet (SSRD) or multi-center study.

You may not qualify if:

• Diagnosis of inflammatory bowel disease, celiac disease, bile salt malabsorption, gastroenteritis or enteric dysmotility
• Severe food allergy
• Serious heart-, lung-, cardiovascular-, malignant- or mental illness
• Ongoing eating disorder
• Pregnancy
• Recent major gastrointestinal surgery
• Alcohol and/or drug addiction

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skåne University Hospital

Malmo, Skåne County, 20502, Sweden

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome; Sucrase-isomaltase deficiency, congenital

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Cecilia Kennbäck, Registered Nurse

  Department of Internal Medicine, Skåne University Hospital, 20502 Malmö

  STUDY CHAIR

Central Study Contacts

Bodil Ohlsson C Professor, MD, PhD

CONTACT

+46+402712660; bodil.ohlsson@med.lu.se

Mauro D'Amato Professor

CONTACT

mdamato@cicbiogune.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 30, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2030
• Last Updated: April 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)