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Identification of IBS Metabotypes Based on Physiological Responses to Food

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653689
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : September 25, 2019
Sponsor:
Collaborator:
Chalmers University of Technology
Information provided by (Responsible Party):
Per Hellström, Uppsala University

Brief Summary:

Irritable bowel syndrome (IBS) is a condition characterized by abdominal pain, bloating, constipation, diarrhea and gas and affects up to 15% of the Western population. In many individuals with IBS, symptoms can be triggered by foods, such as FODMAPs (easily fermentable dietary fiber containing Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols). Some individuals with IBS may also benefit from a gluten-free diet. Current subtypes of IBS are based on symptoms (constipation, diarrhea, and mixed), rather than mechanistic differences. Another promising approach for identifying IBS subtypes is based on grouping individuals into similar metabolic phenotypes, i.e. metabotypes, that share similarities in metabolism and metabolic regulation in response to specific foods. Health and wellbeing could potentially be improved by personalized treatment through tailoring diet to subjects with different IBS subtypes.

To investigate this hypothesis, the investigators will conduct an intervention study on subjects with IBS and identify specific food susceptibilities based on metabolic phenotype (metabotype). In total, 120 women and men with moderate to severe IBS will be recruited. Gluten intolerance, other gastrointestinal disease and abdominal surgery will constitute exclusion criteria. The study will be performed in a double-blind, randomized, placebo-controlled cross-over study design. Study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. IBS metabotypes will be identified by integrative multivariate analysis of molecular phenotype data from metabolomics and microbiota measurements combined with data on bowel habits and stomach discomfort. Study participants will also be subjected to a cocktail provocation containing FODMAPs and gluten to develop a rapid diagnostic test based on identified plasma metabolomic biomarkers of IBS metabotypes.


Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: FODMAP Dietary Supplement: Gluten Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The study will be a double-blinded, randomized, placebo-controlled cross-over study.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: The study will be double-blinded. Neither the participant nor the care providers or the outcome assessor will know which treatment is which.
Primary Purpose: Diagnostic
Official Title: Molecular Phenotyping of IBS Subtypes
Actual Study Start Date : September 10, 2018
Actual Primary Completion Date : June 14, 2019
Actual Study Completion Date : June 14, 2019

Arm Intervention/treatment
Active Comparator: FODMAPs
Dietary supplement: FODMAPs 50 grams three servings per day for seven days.
Dietary Supplement: FODMAP
The intervention will run for seven weeks. During the whole intervention, the participants will hold a baseline diet with no gluten and low intake of FODMAPs. The first week, the participants will consume a one-time cocktail provocation consisting of gluten (17.3 gram) and FODMAPs (50 gram) Thereafter, study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. The daily amount for gluten will be 17.3 gram and the daily amount for FODMAPs will be 50 gram. The order of the three weeks with extra diets (gluten/FODMAPs/control) will be randomized.

Dietary Supplement: Gluten
The intervention will run for seven weeks. During the whole intervention, the participants will hold a baseline diet with no gluten and low intake of FODMAPs. The first week, the participants will consume a one-time cocktail provocation consisting of gluten (17.3 gram) and FODMAPs (50 gram) Thereafter, study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. The daily amount for gluten will be 17.3 gram and the daily amount for FODMAPs will be 50 gram. The order of the three weeks with extra diets (gluten/FODMAPs/control) will be randomized.

Dietary Supplement: Placebo
The intervention will run for seven weeks. During the whole intervention, the participants will hold a baseline diet with no gluten and low intake of FODMAPs. The first week, the participants will consume a one-time cocktail provocation consisting of gluten (17.3 gram) and FODMAPs (50 gram) Thereafter, study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. The daily amount for gluten will be 17.3 gram and the daily amount for FODMAPs will be 50 gram. The order of the three weeks with extra diets (gluten/FODMAPs/control) will be randomized.

Active Comparator: Gluten
Dietary supplement: Gluten 17.3 grams three servings per day for seven days.
Dietary Supplement: FODMAP
The intervention will run for seven weeks. During the whole intervention, the participants will hold a baseline diet with no gluten and low intake of FODMAPs. The first week, the participants will consume a one-time cocktail provocation consisting of gluten (17.3 gram) and FODMAPs (50 gram) Thereafter, study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. The daily amount for gluten will be 17.3 gram and the daily amount for FODMAPs will be 50 gram. The order of the three weeks with extra diets (gluten/FODMAPs/control) will be randomized.

Dietary Supplement: Gluten
The intervention will run for seven weeks. During the whole intervention, the participants will hold a baseline diet with no gluten and low intake of FODMAPs. The first week, the participants will consume a one-time cocktail provocation consisting of gluten (17.3 gram) and FODMAPs (50 gram) Thereafter, study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. The daily amount for gluten will be 17.3 gram and the daily amount for FODMAPs will be 50 gram. The order of the three weeks with extra diets (gluten/FODMAPs/control) will be randomized.

Dietary Supplement: Placebo
The intervention will run for seven weeks. During the whole intervention, the participants will hold a baseline diet with no gluten and low intake of FODMAPs. The first week, the participants will consume a one-time cocktail provocation consisting of gluten (17.3 gram) and FODMAPs (50 gram) Thereafter, study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. The daily amount for gluten will be 17.3 gram and the daily amount for FODMAPs will be 50 gram. The order of the three weeks with extra diets (gluten/FODMAPs/control) will be randomized.

Placebo Comparator: Placebo
Dietary supplement: Placebo rice porrige three servings per day for seven days.
Dietary Supplement: FODMAP
The intervention will run for seven weeks. During the whole intervention, the participants will hold a baseline diet with no gluten and low intake of FODMAPs. The first week, the participants will consume a one-time cocktail provocation consisting of gluten (17.3 gram) and FODMAPs (50 gram) Thereafter, study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. The daily amount for gluten will be 17.3 gram and the daily amount for FODMAPs will be 50 gram. The order of the three weeks with extra diets (gluten/FODMAPs/control) will be randomized.

Dietary Supplement: Gluten
The intervention will run for seven weeks. During the whole intervention, the participants will hold a baseline diet with no gluten and low intake of FODMAPs. The first week, the participants will consume a one-time cocktail provocation consisting of gluten (17.3 gram) and FODMAPs (50 gram) Thereafter, study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. The daily amount for gluten will be 17.3 gram and the daily amount for FODMAPs will be 50 gram. The order of the three weeks with extra diets (gluten/FODMAPs/control) will be randomized.

Dietary Supplement: Placebo
The intervention will run for seven weeks. During the whole intervention, the participants will hold a baseline diet with no gluten and low intake of FODMAPs. The first week, the participants will consume a one-time cocktail provocation consisting of gluten (17.3 gram) and FODMAPs (50 gram) Thereafter, study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. The daily amount for gluten will be 17.3 gram and the daily amount for FODMAPs will be 50 gram. The order of the three weeks with extra diets (gluten/FODMAPs/control) will be randomized.




Primary Outcome Measures :
  1. IBS-SSS [ Time Frame: When the study is completed, anticipated in 1-2 year ]
    The questionnaire IBS-SSS will be used to monitor the IBS symptoms and relate it to how participants metabolically react to the diets (gluten, FODMAPS and control). The IBS-SSS will also be related to how the microbiota potentially could differentiate between individuals and how it can be related to the diets (gluten, FODMAPS and control).


Secondary Outcome Measures :
  1. BMI [ Time Frame: When the study is completed, anticipated in 1-2 year ]
    Body weight (kg) and height (meters) will be combined to report BMI in kg/m^2. It will be related to IBS subtypes and how participants react on the diets (gluten, FODMAPS and control)

  2. Blood pressure [ Time Frame: When the study is completed, anticipated in 1-2 year ]
    Blood pressure (mmHg) will be related to the IBS subtypes and how participants react on the diets (gluten, FODMAPS and control)

  3. Heart rate [ Time Frame: When the study is completed, anticipated in 1-2 year ]
    Heart rate (bpm) will be related to the IBS subtypes and how participants react on the diets (gluten, FODMAPS and control)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Signed informed consent

  • Men and women
  • Medium to severe IBS
  • Age 18-70 years
  • BMI 18.5-38 kg/m2
  • Hb 120-160 g/L
  • S-TSH <4 mIU/L
  • S-CRP <5 mg/L
  • S-Transglutaminase IgA <7 U/mL
  • Willingness to consume rice porridge, once a day for 3 weeks
  • Any medication stable for the last 14 days.

Exclusion Criteria:

  • Gluten intolerance
  • Other gastrointestinal disease (e.g. Crohn's disease, ulcerative colitis)
  • Performed bariatric surgery
  • Previous abdominal surgery, other than appendectomy.
  • Food adaptation (eg. vegetarian, LCHF) in order to achieve abdominal relief
  • Medical treatment for weight reduction.
  • ≥10 kg of weight change in the last 12 months
  • Diastolic blood pressure more than 105 mm Hg at visit 1
  • Systolic blood pressure more than 160 mm at visit 1
  • Blood donation or participation in a clinical study with blood sampling within 30 days prior to screening visit and throughout the study
  • Pregnant or lactating or wishes to become pregnant during the period of the study.
  • Pharmacological medication with drugs known to possibly affect gastrointestinal function, eg antidepressants, neuroleptics, proton pump inhibitors, H2-receptor blockers, non-steroidal anti-inflammatory drugs, opioids, loperamide, cholestyramine, laxatives, metoclopramide, domperidone, prucalopride, linaclotide
  • Unstable pharmacological medication
  • History of drug or alcohol abuse
  • Using nicotine products on a daily basis (incl. chewing gum, patches, snus etc.)
  • Lack of suitability for participation in the trial, for any reason, as judged by the medical doctor or PI.
  • Unable to understand written and spoken Swedish language.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653689


Locations
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Sweden
Uppsala University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University
Chalmers University of Technology
Investigators
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Principal Investigator: Per Hellström, Prof Uppsala University

Publications of Results:
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Responsible Party: Per Hellström, Medical doctor, Professor, Uppsala University
ClinicalTrials.gov Identifier: NCT03653689    
Other Study ID Numbers: OpDiMet1
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available after data base lock.
Time Frame: After September 2020.
Access Criteria: Data sharing for supplement data on publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Per Hellström, Uppsala University:
IBS
metabotype
FODMAP
gluten
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases