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CompletedNCT05688826Updated Jun 27, 2025

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

An interventional study of Sugar in Sucrase-Isomaltase Deficiency and Irritable Bowel Syndrome, sponsored by Region Skane. Completed at 1 site in Sweden. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-27.

Sponsored by Region Skane · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Sucrase-Isomaltase Deficiency
  • Irritable Bowel Syndrome

Keywords

  • gastrointestinal symptoms, glucose
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 40 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Difficulties in taking blood samples
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Sugar load

    Sugar dissolved in water will be ingested during 5 minutes

    Dietary Supplement: Sugar

Interventions

  • Dietary supplementSugar

    75 g sugar dissolved in 0.8 dl water and flavored with lemon. Ingested during 5 minutes

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: From distribution repeatedly up to 2 hours

  2. 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.

    Time frame: From baseline and up to 2 hours, at the same time points as blood glucose is measured

07

Study locations

1 site
  • Department of Internal Medicine, Skåne University Hospital
    Malmo, 20502, Sweden
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05688826
Lead sponsor
Region Skane
Responsible party
Bodil Ohlsson (Professor, Region Skane) — Principal investigator
First posted
Jan 18, 2023
Start date
Jan 4, 2023
Primary completion
Sep 27, 2023
Completion
Jun 23, 2025
Last update
Jun 27, 2025

Study contacts

Cecilia Kennback, Nurse
study director · Department of Internal Medicine, Skåne University Hospital, Malmö

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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