Standardized phenotyping and targeted treatment for IBS patients in Örebro län; a prospective study.
Standardized phenotyping and targeted treatment for IBS patients in Örebro län; a prospective study.
Project number : 261771
Created by: Michiel van Nieuwenhoven, 2019-01-24
Last revised by: Michiel van Nieuwenhoven, 2019-01-24
Project created in: FoU Region Örebro län

PublishedPublished
2019-09-01
Rekrytering/datainsamling pågår

Titel och sammanfattning

Populärvetenskaplig sammanfattning

IBS klassificeras enligt s.k. Rom kriterier. Noggrann kartläggning av IBS patienter kan identifiera olika subgrupper, som möjliggör anpassning av behandling.

Vi vill utföra en standardiserad kartläggning avseende buk-och psykologiska symptom och livskvalitet av IBS-patienter i primärvården via frågelistor. Därefter erbjuder vi ett behandlingsschema innefattande symptom, diet- och psykologisk behandling. Efteråt vill vi utvärdera resultatet av behandlingen för att se om vissa patientkarakteristiker kan förutsäga effektiviteten av olika behandlingar.

Sammanfattning på engelska

The aim of the current project is to perform a phenotyping of IBS patients within the primary care of Örebro län. Based on this phenotyping we will offer a treatment algorithm as described below. Subsequently, we want to retrospectively evaluate the result of the treatment in order to see whether the presence of a certain phenotype can predict the efficacy of different treatments. The results of this study will be implemented in the primary care as a guideline for the general physician providing a tool for phenotyping an IBS patient as well as a simple treatment algorithm.

Projektspecifik information

Ämnesord

checked Allmänmedicin
checked Gastroenterologi


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Studietyp

Prövning av behandling

Randomiserad studie

Nej

Diagnoskod för huvuddiagnos

K55-K64 Andra sjukdomar i tarmen

Diagnoskod för underdiagnos

K55-K64 Andra sjukdomar i tarmen

Multicenterstudie

Nej

Inklusionsstatus

 Planerat antalAntal tillfrågadeScreen-failureAntal randominserade
n=200   

Vetenskaplig sammanfattning

The aim of the current project is to perform a limited phenotyping of IBS patients within the primary care of Örebro län.(Polster et al. 2017) Based on this phenotyping we will offer a treatment algorithm as described below. Subsequently, we want to retrospectively evaluate the result of the treatment in order to see whether the presence of a certain phenotype can predict the efficacy of different treatments. The results of this study will be implemented in the primary care as a guideline for the general physician providing a tool for phenotyping an IBS patient as well as a simple treatment algorithm.

Part 1: 
Aims:
1: Phenotyping of primary care IBS patients in Örebro Län.
2: To investigate the correlation between the different psychometric parameters and IBS symptom severity and Quality of Life.

Design: prospective study
Patients: 200 new IBS patients, age 18-65 years will be recruited within the primary care in Örebro Län. 
Exclusion criteria: 
- Patients who have pharmacological treatment for their IBS symptoms, except OTC products. 
- Patients with an ongoing treatment with Low FODMAP diet.
Patients who are 40 ≥years and suffer from IBS-like symptoms automatically fulfill the local criteria for the Swedish so-called “standardized care chain” regarding colorectal cancer. They will routinely be referred for a colonoscopy. If the colonoscopy is negative, the patients can be included.
 
Methods:
Typically, the first point at which patients with suspected IBS will consult a physician is when their symptoms are bothersome enough to affect their daily life and warrant them seeking medical attention. The majority of the patients has already tried dietary adjustments and has tested OTC products such as loperamide, fiber or probiotics.  
Patients who seek primary care for the first time with their symptoms will be asked to participate. During the initial patient assessment and history taking, symptom triggers (stress, diet) will be identified, as well as comorbidities (e.g. psychological or gynaecological), medication and evt. substance abuse. 
It will be determined whether the patient fulfills the Rome IV criteria and limited tests will be performed. These tests comprise Hb, CRP, celiac disease serology (anti-TTG), TSH, and fecal calprotectin. If these tests are negative and the patient fulfills the Rome IV criteria, the patient will receive a positive diagnosis of IBS.

Subsequently, the patients will be asked to participate in the study and an informed consent will be obtained. The patients will be phenotyped using the tools as suggested by the GENIEUR working group. These tools comprise: 

Rome IV diagnostic IBS questionnaire

IBS severity scoring system:
Gastrointestinal Symptom Rating Scale:
Bristol Stool Form Scale: 
Short form-Nepean dyspepsia index:
Depression Module (PHQ-9): 
Anxiety module (GAD-7): 
Somatic symptom severity (‘somatization’) module (PHQ-15): 
Visceral Sensitivity Index: 
Assessment of disease-specific quality of Life:

Assessment of socioeconomic status of IBS patients.
Assessment of personality according to the “NEO-FFI-3” questionnaire (Big-Five inventory) 
 

Part 2:

Aim:

Implementation and evaluation of a personalized treatment algorithm.

Methods: 

Typically, the first point at which patients with suspected IBS will consult a physician is when their symptoms are bothersome enough to affect their daily life and warrant them seeking medical attention. Usually, patients have already tried diet modification, OTC product such as fiber, loperamide or probiotics before they seek medical attention. 

Patients between 18-65 years, who seek primary care for the first time with their symptoms will be asked to participate. 
Over the counter products and dietary adjustments will be accepted. 
Exclusion criteria: pregnancy, earlier pelvic surgery, bowel diseases other than IBS, current use of antidepressant, current use of Low FODMAP diet, current use of linaclotide, rifaximin or other antibiotics, or eluxadolin.
An informed consent will be obtained. During the initial patient assessment, symptom triggers (stress, diet) will be identified, as well as eventual comorbidities (e.g. psychological or gynaecological). 
It will be determined whether the patient fulfills the Rome IV criteria and limited tests will be performed. These tests comprise Hb, CRP, celiac disease serology (anti-TTG), TSH, and fecal calprotectin. If these tests are negative and the patient fulfills the Rome IV criteria, the patient will receive the diagnosis of IBS. Patients over 40 years old will be referred to the endoscopy unit according to the Swedish guidelines regarding the standardized care chain for colorectal cancer. If the colonoscopy is negative, the patient can be included in the study.

Subsequently, the patient will be phenotyped according to the GENIEUR guidelines, as described in Part 1.

After inclusion and phenotyping, the patients will be categorized in 3 different subtypes, according to their stool consistency: diarrhea-predominant IBS (IBS-D); IBS with mixed bowel habits (IBS-M) and obstipation-predominant IBS (IBS-C). 

The gastrointestinal rating scale (GSRS-IBS version) will be used to establish whether the patient suffer from high, moderate or low gastrointestinal symptoms. These symptoms will be divided in low, moderate and high intensity of diarrhea, constipation, pain and bloating, The PHQ-9 and GAD-7 will be used the categorize patients in high, moderate or low anxiety and depression symptoms. The PHQ-12 will be used to categorize patients in high, moderate and low somatization. The NEO-FFI-3 will be used to identify patients with a high degree of somatization and the MacArthur scale will be use to identify patients with low socio-economic status.

Subsequently, the patient will be offered a treatment algorithm. This algorithm is based on the grade of recommendation and strength of evidence, according to the 2018 recommendations of the American College of Gastroenterology, as well as on the consensus paper of Moayyedi et al. (UEGW journal 2017), in which a panel of 13 international experts in the field of functional gastrointestinal diseases agreed on a treatment algorithm for the management of IBS.

A treatment algorithm will be used, based on the patient’s phenotype and the locally available treatment options and resources.
The initial treatment may comprise one or more of the proposed treatment options, as described in the treatment algorithm. After 4 weeks a telephonic reassessment via will be carried out and, if necessary, the treatment will be adjusted. After 12 weeks the final evaluation of the efficacy of the treatment algorithm will be assessed. The treatment compliance will be evaluated and the patient will be requested to fill in the same phenotyping questionnaires as used at inclusion.

Data analysis:
Compliance to the treatment and patient tolerability will be determined. Data will be analyzed using SPSS. Descriptive statistics of baseline demographics will be performed. Treatment efficacy will be compared using the chi-square test and paired Student t-test. 

The primary outcome measures comprise the effect of treatment on IBS-SSS score and improvement on the IBS-QoL. A reduction in IBS-SSS total score of 50 reflects a clinically meaningful improvement.

Secondary outcome parameters comprise the effect of treatment on different phenotyping questionnaires regarding psychometric scores and other symptom scores.

To establish which parameter of the IBS phenotype has the most effect on the IBS-SSS and IBS-QoL, a multiple regression analysis will be performed. Correlations between IBS-QOL total score, IBS-SSS and the other parameters will be calculated using Pearson´s correlation coefficient.

Involverade parter

Arbetsplats

Added workplaces

Regioner - Region Örebro Län - Hälso- och sjukvård - Område medicin och rehabilitering - Medicinska kliniken workplace verified by Region Örebro län on 2018-06-14

Projektägare är huvudprövare eller ansvarig forskare

checked Ja


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Medarbetare i projektet

Ahmed Al-Ahmadi
Distriktsläkare, Skebäcks vårdcentral

Roll i projektet

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Stefan Jansson
Distriktsläkare, Brickebackens vårdcentral, Hälso- och sjukvård, Universitetssjukvårdens forskningscentrum

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checked Medarbetare
Yang Cao
Statistiker, Kliniskt forskningscentrum

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checked Medarbetare
Jussi Rauma
Specialistläkare, Olaus Petri vårdcentral

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checked Medarbetare

Standardized phenotyping and targeted treatment for IBS patients in Örebro län; a prospective study., from FoU Region Örebro län
http://www.researchweb.org/is/en/fourol/project/261771