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Comparison Between Low FODMAP and SSRD in IBS

Primary Purpose

IBS - Irritable Bowel Syndrome

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

About this trial

This is an interventional treatment trial for IBS - Irritable Bowel Syndrome focused on measuring IBS, low FODMAP, SSRD

Eligibility Criteria

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

Inclusion Criteria:

  • Verified IBS according to Rom IV criteria.

Exclusion Criteria:

  • Serious mental disease
  • Serious somatic disease
  • Abuse
  • Inability to understand the Swedish language
  • Already on a diet

Sites / Locations

  • Deartment of INternal Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dietary intervention with Low FODMAP

Dietary intervention with SSRD

Arm Description

The participants are given oral and written instructions on which diet that contains low contents of FODMAP.

The participants are given oral and written instructions on which diet that contains SSRD.

Outcomes

Primary Outcome Measures

Efficiency on bowel and extra-intestinal symptoms
To assess bowel symptoms and extra-intestinal symptoms after the dietary interventions by evaluation of irritable bowel syndrome-symptom severity score (IBS-SSS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Efficiency on bowel and extra-intestinal symptoms
To assess bowel symptoms and extra-intestinal symptoms after the dietary interventions by evaluation of IBS-SSS. This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Efficiency on bowel symptoms
To assess bowel symptoms after the dietary interventions by evaluation of visual analog scale for irritable bowel syndrome (VAS-IBS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Efficiency on bowel symptoms
To assess bowel symptoms after the dietary interventions by evaluation of visual analog scale for irritable bowel syndrome (VAS-IBS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.

Secondary Outcome Measures

Effects on plasminogen activator inhibitor-1 (PAI-1)
The investigator will analyze plasminogen activator inhibitor-1 (PAI-1) by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Effects on C-peptide
The investigator will analyze C-peptide by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Effects on insulin
The investigator will analyze insulin by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Effects on leptin
The investigator will analyze leptin by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Effects on gastric inhibitory peptide (GIP)
The investigator will analyze GIP by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Effects on visfatin
The investigator will analyze visfatin by mesoscale to see and compare the effects of the two different diets.
Effects on ghrelin
The investigator will analyze ghrelin by mesoscale to see and compare the effects of the two different diets.
Effects on gut microbiota by whole genome sequencing of feces
The investigator will analyze fecal microbiota by whole genome sequencing to see and compare the effects of the two different diets
Effects on microRNA
The investigator will analyze microRNA to see and compare the effects of the two different diets
Effects on DNA methylation
The investigator will analyze DNA methylation to see and compare the effects of the two different diets
Effects depending on genetics
The investigator will analyze sucrase-isomaltase (SI) genes to see if the genetic profile hais of importance for the clinical effect of the two diets
Effects on vitamin A
The investigator will analyze values of vitamin A in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on vitamin B
The investigator will analyze values of vitamin B in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on vitamin C
The investigator will analyze values of vitamin C in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on vitamin D
The investigator will analyze values of vitamin D in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on phosphorous
The investigator will analyze values of phosphorous in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on zinc
The investigator will analyze values of zinc in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on magnesium
The investigator will analyze values of magnesium in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on albumin
The investigator will analyze values of albumin in blood before and after the study to compare the effects on the nutritional status by the two diets.
Effects on metabolomics and proteomics
The investigator will analyze metabolomics and proteomics in blood to see and compare the effects of the two different diets
Effects on quality of life by RAND-36 (comprehensive short-form generic profile for health-related quality of life (HRQoL))
The investigator will analyze how the two different diets influence quality of life, measured by RAND-36, to compare the effects of the two different diets. RAND-36 is comprised of 36 items on 5-point Likert scale, the higher score the better quality of life, that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.
Effects on eating disturbances
The investigator will analyze how the two different diets influence eating disturbances measured by SCOFF, to compare the effects of the two different diets. SCOFF contains 5 questions answered by "yes" or "no": 1) Do you make yourself Sick because you feel uncomfortably full?, 2) Do you worry that you have lost Control over how much you eat?, 3)Have you recently lost more than One stone (14 lb) in a 3-month period?, 4)Do you believe yourself to be Fat when others say you are too thin?, and 5) Would you say that Food dominates your life?
Effects on healthcare consumption
The investigator will analyze how the two different diets influence healthcare consumption by asking the participants about how many times they have visited a Healthcare giver before, during and after the study, to compare the effects of the two different diets

Full Information

First Posted
November 29, 2021
Last Updated
April 26, 2022
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT05192603
Brief Title
Comparison Between Low FODMAP and SSRD in IBS
Official Title
Comparison in the Effects and Mechanisms Between Low Fermentable-, Oligo-, di-, and Monosaccharides and Polyols (FODMAP) and Starch- and Sucrose-reduced Diet (SSRD) in Irritable Bowel Syndrome (IBS)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2029 (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 aim of the present study is to compare the efficiency of low FODMAP and SSRD to reduce symptoms in IBS, and to study the mechanisms and consequences of the two diets.
Detailed Description
The investigator will perform a study on 200 subjects with verified irritable bowel syndrome (IBS). Participants will be recruited from the clinic of Gastroenterology or Internal medicine as well as primary health care centers. At the start of the study, participants will complete protocols concerning Rom IV criteria (to validate that the IBS criteria are ful-filled) as well as IBS symptom rating scales irritable bowel syndrome-symptoms severity scores (IBS-SSS) and visual analog scale for irritable bowel syndrome (VAS-IBS). The Item Health Survey 1.0 (distributed by RAND), RAND-36, includes the same items as those in the Short-Form Health Survey (SF-36), and evaluates the quality of Life. SCOFF is a brief questionnaire that asks the five questions about eating disturbances (Do you make yourself Sick because you feel uncomfortably full? Do you worry you have lost Control over how much you eat? Have you recently lost more than One stone in a 3 month period? Do you believe yourself to be Fat when others say you are too thin? Would you say that Food dominates your life?). Participants will be examined by an investigator who will complete protocols of clinical data. Blood and fecal samples will be collected by the investigator. Study participants will thereafter be randomized to receive either low FODMAP (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols) diet (n=100), or a SSRD diet (starch ans sucrose-reduced diet) (n=100). After 4 weeks of dietary intervention, there will be a follow-up where blood and fecal samples are once again collected. At this point in time, participants will also fill in IBS symptom rating scales again. The participants are then free to eat whatever they want to, and another 5 months later, they will be examined again, the same protocols will be completed, and blood and fecal samples are collected. The investigator will use samples from baseline, 4 weeks and 6 months, for genetic/epigenetic (including genomic-wide association studies), metabolomics, proteomics, nutritional data, gut microbiota, and inflammatory parameter analyses. Statistics The investigator will use Mann-Whitney U-test and Wilcoxon test to study differences in the above-mentioned parameters between the two treatment groups, as well as before and after dietary intervention, respectively. For analyses of genetic/epigenetics, metabolomics, proteomics, and microbiota, the investigator will use bioinformatics and biostatistics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome
Keywords
IBS, low FODMAP, SSRD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, open study for dietary intervention
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dietary intervention with Low FODMAP
Arm Type
Experimental
Arm Description
The participants are given oral and written instructions on which diet that contains low contents of FODMAP.
Arm Title
Dietary intervention with SSRD
Arm Type
Experimental
Arm Description
The participants are given oral and written instructions on which diet that contains SSRD.
Intervention Type
Dietary Supplement
Intervention Name(s)
low FODMAP or SSRD
Intervention Description
The participants are given oral and written information about each diet. No food is delivered from the investigator to the participant
Primary Outcome Measure Information:
Title
Efficiency on bowel and extra-intestinal symptoms
Description
To assess bowel symptoms and extra-intestinal symptoms after the dietary interventions by evaluation of irritable bowel syndrome-symptom severity score (IBS-SSS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Time Frame
4 weeks dietary intervention
Title
Efficiency on bowel and extra-intestinal symptoms
Description
To assess bowel symptoms and extra-intestinal symptoms after the dietary interventions by evaluation of IBS-SSS. This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Time Frame
A follow-up 5 months after the end of the intervention
Title
Efficiency on bowel symptoms
Description
To assess bowel symptoms after the dietary interventions by evaluation of visual analog scale for irritable bowel syndrome (VAS-IBS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Time Frame
4 weeks dietary intervention
Title
Efficiency on bowel symptoms
Description
To assess bowel symptoms after the dietary interventions by evaluation of visual analog scale for irritable bowel syndrome (VAS-IBS). This questionnaire contains VAS scales ranging from 0-100 where a higher score means worse symptoms.
Time Frame
A follow-up 5 months after the end of the intervention
Secondary Outcome Measure Information:
Title
Effects on plasminogen activator inhibitor-1 (PAI-1)
Description
The investigator will analyze plasminogen activator inhibitor-1 (PAI-1) by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on C-peptide
Description
The investigator will analyze C-peptide by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on insulin
Description
The investigator will analyze insulin by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on leptin
Description
The investigator will analyze leptin by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on gastric inhibitory peptide (GIP)
Description
The investigator will analyze GIP by enzyme-linked immunosorbent assay (ELISA) to see and compare the effects of the two different diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on visfatin
Description
The investigator will analyze visfatin by mesoscale to see and compare the effects of the two different diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on ghrelin
Description
The investigator will analyze ghrelin by mesoscale to see and compare the effects of the two different diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on gut microbiota by whole genome sequencing of feces
Description
The investigator will analyze fecal microbiota by whole genome sequencing to see and compare the effects of the two different diets
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on microRNA
Description
The investigator will analyze microRNA to see and compare the effects of the two different diets
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on DNA methylation
Description
The investigator will analyze DNA methylation to see and compare the effects of the two different diets
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects depending on genetics
Description
The investigator will analyze sucrase-isomaltase (SI) genes to see if the genetic profile hais of importance for the clinical effect of the two diets
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on vitamin A
Description
The investigator will analyze values of vitamin A in blood before and after the study to compare the effects on the nutritional status by the two diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on vitamin B
Description
The investigator will analyze values of vitamin B in blood before and after the study to compare the effects on the nutritional status by the two diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on vitamin C
Description
The investigator will analyze values of vitamin C in blood before and after the study to compare the effects on the nutritional status by the two diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on vitamin D
Description
The investigator will analyze values of vitamin D in blood before and after the study to compare the effects on the nutritional status by the two diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on phosphorous
Description
The investigator will analyze values of phosphorous in blood before and after the study to compare the effects on the nutritional status by the two diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on zinc
Description
The investigator will analyze values of zinc in blood before and after the study to compare the effects on the nutritional status by the two diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on magnesium
Description
The investigator will analyze values of magnesium in blood before and after the study to compare the effects on the nutritional status by the two diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on albumin
Description
The investigator will analyze values of albumin in blood before and after the study to compare the effects on the nutritional status by the two diets.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on metabolomics and proteomics
Description
The investigator will analyze metabolomics and proteomics in blood to see and compare the effects of the two different diets
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on quality of life by RAND-36 (comprehensive short-form generic profile for health-related quality of life (HRQoL))
Description
The investigator will analyze how the two different diets influence quality of life, measured by RAND-36, to compare the effects of the two different diets. RAND-36 is comprised of 36 items on 5-point Likert scale, the higher score the better quality of life, that assess eight health concepts: physical functioning, role limitations caused by physical health problems, role limitations caused by emotional problems, social functioning, emotional well-being, energy/fatigue, pain, and general health perceptions.
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on eating disturbances
Description
The investigator will analyze how the two different diets influence eating disturbances measured by SCOFF, to compare the effects of the two different diets. SCOFF contains 5 questions answered by "yes" or "no": 1) Do you make yourself Sick because you feel uncomfortably full?, 2) Do you worry that you have lost Control over how much you eat?, 3)Have you recently lost more than One stone (14 lb) in a 3-month period?, 4)Do you believe yourself to be Fat when others say you are too thin?, and 5) Would you say that Food dominates your life?
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months
Title
Effects on healthcare consumption
Description
The investigator will analyze how the two different diets influence healthcare consumption by asking the participants about how many times they have visited a Healthcare giver before, during and after the study, to compare the effects of the two different diets
Time Frame
4 weeks dietary intervention, with a follow-up after another 5 months

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: Verified IBS according to Rom IV criteria. Exclusion Criteria: Serious mental disease Serious somatic disease Abuse Inability to understand the Swedish language Already on a diet
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bodil Ohlsson, Professor
Organizational Affiliation
Department of Internal Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bodil Roth, PhD
Organizational Affiliation
Department of Internal Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Deartment of INternal Medicine
City
Malmö
ZIP/Postal Code
20502
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison Between Low FODMAP and SSRD in IBS

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