NCT05688826

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2023

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

9 months

First QC Date

January 9, 2023

Last Update Submit

June 23, 2025

Conditions

Keywords

gastrointestinal symptoms, glucose

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Sugar load

EXPERIMENTAL

Sugar dissolved in water will be ingested during 5 minutes

Dietary Supplement: Sugar

Interventions

SugarDIETARY_SUPPLEMENT

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

Sugar load

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Difficulties in taking blood samples

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine, Skåne University Hospital

Malmo, 20502, Sweden

Location

MeSH Terms

Conditions

Sucrase-isomaltase deficiency, congenitalIrritable Bowel Syndrome

Interventions

Sugars

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Cecilia Kennback, Nurse

    Department of Internal Medicine, Skåne University Hospital, Malmö

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Patients with normal genes and with functional variants of sucrase-isomaltase genes
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2023

First Posted

January 18, 2023

Study Start

January 4, 2023

Primary Completion

September 27, 2023

Study Completion

June 23, 2025

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations