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

Primary Purpose

Sucrase-Isomaltase Deficiency, Irritable Bowel Syndrome

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Sugar
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sucrase-Isomaltase Deficiency focused on measuring gastrointestinal symptoms, glucose

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants of our previous clinical trial with SSRD diet (NCT03306381) Exclusion Criteria: Difficulties in taking blood samples

Sites / Locations

  • Department of Internal Medicine, Skåne University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sugar load

Arm Description

Sugar dissolved in water will be ingested during 5 minutes

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Full Information

First Posted
January 9, 2023
Last Updated
January 18, 2023
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT05688826
Brief Title
The Effect of Sugar Load in IBS Patients Depending on Sucrase-isomaltase Genes
Official Title
Comparison of Sugar Load Between Normal and Functional Variants of Sucrase-isomaltase Genes in IBS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 4, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sucrase-Isomaltase Deficiency, Irritable Bowel Syndrome
Keywords
gastrointestinal symptoms, glucose

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with normal genes and with functional variants of sucrase-isomaltase genes
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sugar load
Arm Type
Experimental
Arm Description
Sugar dissolved in water will be ingested during 5 minutes
Intervention Type
Dietary Supplement
Intervention Name(s)
Sugar
Intervention Description
75 g sugar dissolved in 0.8 dl water and flavored with lemon. Ingested during 5 minutes
Primary Outcome Measure Information:
Title
Changes from baseline of blood glucose levels
Description
Measurement of glucose levels in blood drawn from an intravenous needle and analyzed at the Department of Clinical Chemostry
Time Frame
From distribution repeatedly up to 2 hours
Title
Change from baseline of gastrointestinal symptoms
Description
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.
Time Frame
From baseline and up to 2 hours, at the same time points as blood glucose is measured

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants of our previous clinical trial with SSRD diet (NCT03306381) Exclusion Criteria: Difficulties in taking blood samples
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia Kennback, Nurse
Organizational Affiliation
Department of Internal Medicine, Skåne University Hospital, Malmö
Official's Role
Study Director
Facility Information:
Facility Name
Department of Internal Medicine, Skåne University Hospital
City
Malmö
ZIP/Postal Code
20502
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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