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

• Sponsor: Region Skane (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05688826
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 25.8
• Patients Per Site Per Month: 3.9

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Sucrase-Isomaltase Deficiency; Irritable Bowel Syndrome	Dietary Supplement: Sugar	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Patients with normal genes and with functional variants of sucrase-isomaltase genesPatients with normal genes and with functional variants of sucrase-isomaltase genes
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Comparison of Sugar Load Between Normal and Functional Variants of Sucrase-isomaltase Genes in IBS
• Actual Study Start Date: Jan 4, 2023
• Anticipated Primary Completion Date: Feb 28, 2024
• Anticipated Study Completion Date: Feb 28, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes from baseline of blood glucose levels [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

2. Change from baseline of gastrointestinal symptoms [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• Difficulties in taking blood samples

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Internal Medicine, Skåne University Hospital	Malmö		Sweden	20502

Sponsors and Collaborators

• Region Skane

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bodil Ohlsson, Professor, Region Skane
• ClinicalTrials.gov Identifier: NCT05688826
• Other Study ID Numbers: Sugarload-2023
• First Posted: Jan 18, 2023
• Last Update Posted: Jan 20, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bodil Ohlsson, Professor, Region Skane: gastrointestinal symptoms, glucose
• Additional relevant MeSH terms: Irritable Bowel Syndrome

Study Results

No Results Posted as of Jan 20, 2023