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

April 9, 2024 updated by: Bodil Ohlsson, Region Skane

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden, 20502
        • Department of Internal Medicine, Skåne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants of our previous clinical trial with SSRD diet (NCT03306381)

Exclusion Criteria:

  • Difficulties in taking blood samples

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sugar load
Sugar dissolved in water will be ingested during 5 minutes
Dietary supplement: Sugar
75 g sugar dissolved in 0.8 dl water and flavored with lemon. Ingested during 5 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline of blood glucose levels
Time Frame: From distribution repeatedly up to 2 hours
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
Change from baseline of gastrointestinal symptoms
Time Frame: From baseline and up to 2 hours, at the same time points as blood glucose is measured
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Study Director: Cecilia Kennback, Nurse, Department of Internal Medicine, Skåne University Hospital, Malmö

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2023

Primary Completion (Actual)

September 27, 2023

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

January 9, 2023

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sugarload-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on Sugar

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe