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NCT05688826 Clinical Trial

The Effect of Sugar Load in IBS Patients Depending on Sucrase-isomaltase Genes

Irritable Bowel Syndrome Clinical Trial

Official title:
Comparison of Sugar Load Between Normal and Functional Variants of Sucrase-isomaltase Genes in IBS

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05688826
Other study ID # Sugarload-2023
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 4, 2023
Est. completion date February 28, 2025

Study information
Verified date April 2024
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators know that many patients with irritable bowel syndrome (IBS) have functional variants of genes coding for sucrase-isomaltase enzymes. The investigators will now examine whether these functional variants are associated with defect degradation of sucrose and associated gastrointestinal symptoms

Description:

The investigators have in a previous study included IBS patients for treatment with a starch- and sucrose reduced diet (SSRD). The investigators found a great improvement of symptoms. The investigators gene-tested those patients, and now have the full identification of all functional variants encoding sucrase-isomaltase enzymes. The investigators will invite patients from this previous study with normal genes and functional variants of genes. The patients will come fasting over night to the department of clinical research. The participants will ingest 75 g sugar dissolved in 0.8 dl water and flavored with lemon, to ingest during 5 minutes. After that, glucose will determined repeatedly up to 2 hours afterwards. At the same time, the participants have to assess their gastrointestinal sympotms on visual analogue scales (VAS). The investigators will compare the raise in b-glucose and symptoms between the groups of patients, divided into gene expression.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date February 28, 2025
Est. primary completion date September 27, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Participants of our previous clinical trial with SSRD diet (NCT03306381) Exclusion Criteria: - Difficulties in taking blood samples

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Sugar
75 g sugar dissolved in 0.8 dl water and flavored with lemon. Ingested during 5 minutes

Locations
Country Name City State
Sweden Department of Internal Medicine, Skåne University Hospital Malmö

Sponsors (1)
Lead Sponsor Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Changes from baseline of blood glucose levels Measurement of glucose levels in blood drawn from an intravenous needle and analyzed at the Department of Clinical Chemostry From distribution repeatedly up to 2 hours
Primary Change from baseline of gastrointestinal symptoms Measurment of gastrointestinal symptoms on a visual analog scale measuring symptoms, range 0-100 mm, repeatedly at the same time points as blood glucose is measured. The higher scores, the worse symptoms. From baseline and up to 2 hours, at the same time points as blood glucose is measured
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