Irritable Bowel SyndromeROLIBSNCT04770883
Psychological and Dietary Treatment in IBS
A study testing Internet based cognitive behavioral therapy. and Low FODMAP diet therapy in people with Irritable Bowel Syndrome, run by Region Örebro County at 1 site in Sweden.
Trial summary
Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal (GI) condition which is strongly associated with dietary and psychosocial factors. Management of IBS remains challenging for primary health care. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Internet based cognitive behavioral therapy. and Low FODMAP diet therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2021to 31 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IBS symptom severity score of at least 175 (moderate to severe symptoms).
- Age 18 to 65 years.
Who cannot join
- Abnormal results on standard screening laboratory tests; this means that patients with abnormal thyroid-stimulating hormone (TSH), increased f-calprotectin or positive celiac disease serology will not be included.
- Severe psychiatric, systemic inflammatory diseases, inflammatory bowel disease and other severe diseases such as cancer.
- Current drug or alcohol abuse.
- Inability to complete questionnaires in Swedish.
- Current pharmacological treatment for their IBS symptoms, except for "over the counter" products such as loperamide or fiber.
- Ongoing use of low FODMAP (Fermentable Mono-, di-, oligosaccharides, and polyols) diet. A current lactose free or gluten free diet will not be accepted. Earlier lactose or gluten free diet will be accepted after a wash-out period of at least 2 weeks.
- Current psychological treatment.
- Current psychological treatment.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Skebäck primary health care center
Örebro, 70215
Ahmed Al-Ahmadi, MD, 0046739083380, ahmed.al-ahmadi@regionorebrolan.se
Michiel van Nieuwenhoven, Docent
About this study
Official title: Phenotyping and Treatment of Primary Health Care IBS Patients. A Randomized Controlled Trial
Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal (GI) condition which is strongly associated with dietary and psychosocial factors. Management of IBS remains challenging for primary health care.
The aim is to perform a comprehensive phenotyping of patients with IBS within the primary health care in Region Örebro County, Sweden. Following this phenotyping, the investigators will perform a prospective randomized controlled trial of two different treatments versus control as described below. Subsequently, the investigators want to evaluate the result of the treatments in order to see whether the presence of a certain phenotype can predict the efficacy of different treatments.
Read more
Our hypothesis is that the presence of certain baseline symptom characteristics in patients with IBS can predict how effective internet based cognitive behavioral therapy (iCBT) and low FODMAP (low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) treatment will be for each patient.
200 patients with IBS aged 18-65 years will be recruited from the primary health care in Region Örebro County.
The study plan is structured as follows:
- Phenotyping of IBS patients. Investigation of the correlation between different psychological parameters, IBS symptom severity and Quality of Life.
- The effect and outcome of 10-weeks internet-based cognitive behavioral therapy (iCBT) versus control in IBS patients.
- The effect and outcome of 10-weeks low FODMAP diet versus control in IBS patients.
- Comparison of iCBT and low FODMAP treatment in IBS patients and identification of baseline phenotypic characteristics predicting treatment outcome for both treatments.
Stool and blood samples will be taken before and after treatment for analysis of gut microbiota, proteomics and epigenetics and to correlate these with the clinical phenotype.
All participants will undergo phenotyping regarding GI symptoms and psychological variables using questionnaires. Participants will afterwards be randomised to either 10 weeks treatment with iCBT (80 participants), low FODMAP (80 participants) or control group (40 participants) (2:2:1 randomization). The control group will wait 10 weeks before being randomised to either iCBT (20 participants) or low FODMAP (20 participants).
Significance
This study will provide effective and individualized treatment for IBS patients. This may lead to the development of a guideline to improve the effectiveness of treatment and care for patients with IBS.
Read the detailed description
Part 1
Study design:
Cross-sectional observational study.
Study population:
200 IBS patients, M/F, age 18-65 years, will be recruited under a period of 4 years from the primary health care in Region Örebro County. Patients will also be recruited from the general public using websites, social media and advertisements.
Data collection:
After informed consent is signed, a doctor's assessment is made including medical history, physical examination and laboratory tests.
For assessment of the IBS symptoms but also comorbid conditions such as upper GI symptoms, somatization and psychiatric symptoms, 12 different validated questionnaires will be used to identify sub-populations (phenotypes).
All patients will be asked to fill in these questionnaires before starting, during and after treatment.
Stool and blood samples will be taken at baseline and after treatment and will be stored at a biobank for later analysis of microbiomics, proteomics and epigenetics.
Analysis:
Descriptive statistics to identify different IBS features, and Pearson's correlations to study between-person correlations in a correlation network to see which parameters correlate most with the IBS symptom scale (GSRS-IBS) and Quality of life (IBS-QoL). They will be used as the dependent variables in multiple linear regression analysis with the other parameters as independent variables.
Part 2 and 3
Study design:
Randomized controlled clinical trial.
Study population:
Patients will then be randomized to either iCBT (80 patients), Low FODMAP diet (80 patients) or control group (40 patients) (2:2:1 randomization). The control group will wait 10 weeks before being randomised to treatment with either iCBT (20 patients) or low FODMAP diet (20 patients).
Treatments:
iCBT and Low FODMAP diet (see below).
Analysis:
Treatment efficacy analysis using linear mixed models on the primary outcome measures with time as within-subject factor (random intercept random slope models) and group as between-subject factor, with the time-by-group interaction effect testing the hypothesis of a stronger response to treatment compared to waiting list control. Continuous variables will be used to maximize power. Within-person correlations between IBS features. Linear mixed models and latent class growth analysis to establish which baseline parameters of IBS predict the treatment effect on the GSRS-IBS and IBS-QoL. Cross-lagged panel models to investigate the temporal order of change in the different outcome variables, while controlling for stabilities over time and cross-sectional correlations.
Part 4
Comparison of psychological and dietary treatment in IBS patients. At this point the investigators will have 100 patients who were treated with ICBT and 100 patients who were treated with low-FODMAP diet. Treatment efficacy will be analyzed using linear mixed models on the primary outcome measures with time as within-subject factor (random intercept random slope models) and group as between-subject factor, with the time-by-group interaction effect testing the hypothesis of a stronger response to iCBT compared to low-FODMAP.
Power calculation:
It is estimated that 100 participants per group need to be included in the treatment studies and the analysis of predictors of treatment responses with regard to a dropout rate of 10% (part 2-4). For part 1, the analysis can be performed on the entire study population of 200 participants, which gives 90% power to be able to detect an effect size (Cohen's f² = 0.10) in multiple regression analysis with 9 independent variables (derived from questionnaire PHQ-9, GAD-7, PHQ-12, VSI, IBS-BRQ and NEO-FFI) predicting the severity of IBS symptoms (IBS-SSS and GSRS-IBS) and quality of life (IBS-QoL).
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Internet based cognitive behavioral therapy., Low FODMAP diet therapy
- Keywords
- Irritable Bowel Syndrome, Cognitive Behavioral Therapy, Diet Therapy, Low FODMAP Diet, Internet Based Cognitive Behavioral Therapy, Psychological Therapy, Psychological Parameters, Phenotyping of Irritable Bowel Syndrome Patients, Gastrointestinal Symptoms, Quality of Life, Irritable Bowel Syndrome Symptom Severity
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet based cognitive behavioral therapy.Behavioural
Patients will receive iCBT for 10 weeks, divided into five successive steps. The iCBT will be guided by online therapists and emphasizes acceptance of symptoms through exposure training. Patients have to report that they have worked through a treatment step to get access to the next. Patients will be encouraged to work through steps 1-4 during the first half of the treatment and to spend the latter half on step 5, in which exposure exercises will be introduced. The treatment aims to break the vicious cycle between avoidance behavior, symptom severity and functional impairment.
Low FODMAP diet therapyDietary supplement
Patients will receive 10 weeks of standardized treatment with low FODMAP diet consisting of 3 stages: FODMAP restriction; FODMAP reintroduction and FODMAP personalization. These stages will be covered in at least three appointments by primary care dieticians in Region Örebro County.
| Study group | Role | What they receive |
|---|---|---|
| Internet based cognitive behavioral therapy group | Experimental | 80 patients will be randomized to receive iCBT. Psychological therapy is effective in IBS patients. The treatment takes 10 weeks and is divided into five successive steps. Patients have to report that they have worked through a treatment step to get access to the next. The patients will be encouraged to work through steps 1-4 during the first half of the treatment and to spend the latter half of the treatment on step 5, in which exposure exercises are introduced. A psychologist/CBT therapist will manage the online therapeutic contact with the patients. Receives: Behavioral: Internet based cognitive behavioral therapy. |
| Low FODMAP group | Experimental | 80 patients will then be randomized to receive Low FODMAP diet. FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols) are poorly absorbed short-chain carbohydrates including fructose (in excess of glucose), lactose, polyols, fructans and galacto-oligosaccharides. The concept of considering all these molecules collectively as a treatment for IBS is relatively new. Understanding of FODMAPs comprises mechanisms of action such as luminal distension from their osmotic effect and rapid fermentation to hydrogen. These findings have led to increased application of the low FODMAP diet to manage IBS symptoms. Treatment will undergo 10 weeks supervised monotherapy with low FODMAP diet. This will be done with the help of professional dieticians in Örebro region, who will meet the patients and inform them how this diet works as well as follow up. Receives: Dietary Supplement: Low FODMAP diet therapy |
| Control group | Active comparator | The control Group (40 patients) will wait for 10 weeks before being randomised to treatment with either iCBT or low FODMAP diet. Receives: Behavioral: Internet based cognitive behavioral therapy.; Dietary Supplement: Low FODMAP diet therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Symptom Rating Scale-IBS (GSRS-IBS)
Measures disease-specific symptoms in IBS patients
Measured: 10 weeks
The IBS quality of life questionnaire (IBS-QoL)
Assessment of disease-specific quality of Life
Measured: 10 weeks
Secondary outcomes (10)
Patient Health Questionnaire Anxiety module (GAD-7)
Measures anxiety
Measured: 10 weeks
Patient Health Questionnaire Depression Module (PHQ-9)
Measures depressive symptoms
Measured: 10 weeks
Patient Health Questionnaire Somatic symptom severity ('somatization') module (PHQ-12)
Measures somatic symptom severity
Measured: 10 weeks
Visceral Sensitivity Index (VSI) questionnaire
Measures GI symptom-specific anxiety
Measured: 10 weeks
The Irritable Bowel Syndrome-Behavioural Responses Questionnaire (IBSBRQ)
Measures treatment outcome of iCBT.
Measured: 10 weeks
Nepean Dyspepsia Index (NDI)
Measures quality of life in functional dyspepsia
Measured: 10 weeks
IBS severity scoring system (IBS-SSS)
Measures GI symptoms and effect of IBS on life in general
Measured: 10 weeks
Rome IV diagnostic questionnaire
Diagnostic IBS criteria
Measured: 10 weeks
The Neuroticism-Extraversion-Openness Five Factor Inventory-3 (NEO-FFI-3) questionnaire
Assessment of personality type based on the five-factor model: Openness, conscientiousness, extraversion, agreeableness, and neuroticism.
Measured: 10 weeks
Bristol Stool Form Scale
Describes the stool consistency
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is an open labelled, randomized, controlled clinical trial, with a ratio 2:2:1.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770883
- Sponsor's protocol ID
- 261771
- Acronym
- ROLIBS
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2021
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotyping and Treatment of Primary Health Care IBS Patients. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04770883
- Acronym / sponsor ID
- ROLIBS / 261771
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, Cognitive Behavioral Therapy, Diet Therapy, Low FODMAP Diet, Internet Based Cognitive Behavioral Therapy, Psychological Therapy, Psychological Parameters, Phenotyping of Irritable Bowel Syndrome Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal (GI) condition which is strongly associated with dietary and psychosocial factors. Management of IBS remains challenging for primary health care.
The aim is to perform a comprehensive phenotyping of patients with IBS within the primary health care in Region Örebro County, Sweden. Following this phenotyping, the investigators will perform a prospective randomized controlled trial of two different treatments versus control as described below. Subsequently, the investigators want to evaluate the result of the treatments in order to see whether the presence of a certain phenotype can predict the efficacy of different treatments.
Our hypothesis is that the presence of certain baseline symptom characteristics in patients with IBS can predict how effective internet based cognitive behavioral therapy (iCBT) and low FODMAP (low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols) treatment will be for each patient.
200 patients with IBS aged 18-65 years will be recruited from the primary health care in Region Örebro County.
The study plan is structured as follows:
- Phenotyping of IBS patients. Investigation of the correlation between different psychological parameters, IBS symptom severity and Quality of Life.
- The effect and outcome of 10-weeks internet-based cognitive behavioral therapy (iCBT) versus control in IBS patients.
- The effect and outcome of 10-weeks low FODMAP diet versus control in IBS patients.
- Comparison of iCBT and low FODMAP treatment in IBS patients and identification of baseline phenotypic characteristics predicting treatment outcome for both treatments.
Stool and blood samples will be taken before and after treatment for analysis of gut microbiota, proteomics and epigenetics and to correlate these with the clinical phenotype.
All participants will undergo phenotyping regarding GI symptoms and psychological variables using questionnaires. Participants will afterwards be randomised to either 10 weeks treatment with iCBT (80 participants), low FODMAP (80 participants) or control group (40 participants) (2:2:1 randomization). The control group will wait 10 weeks before being randomised to either iCBT (20 participants) or low FODMAP (20 participants).
Significance
This study will provide effective and individualized treatment for IBS patients. This may lead to the development of a guideline to improve the effectiveness of treatment and care for patients with IBS.
Detailed description
Part 1
Study design:
Cross-sectional observational study.
Study population:
200 IBS patients, M/F, age 18-65 years, will be recruited under a period of 4 years from the primary health care in Region Örebro County. Patients will also be recruited from the general public using websites, social media and advertisements.
Data collection:
After informed consent is signed, a doctor's assessment is made including medical history, physical examination and laboratory tests.
For assessment of the IBS symptoms but also comorbid conditions such as upper GI symptoms, somatization and psychiatric symptoms, 12 different validated questionnaires will be used to identify sub-populations (phenotypes).
All patients will be asked to fill in these questionnaires before starting, during and after treatment.
Stool and blood samples will be taken at baseline and after treatment and will be stored at a biobank for later analysis of microbiomics, proteomics and epigenetics.
Analysis:
Descriptive statistics to identify different IBS features, and Pearson's correlations to study between-person correlations in a correlation network to see which parameters correlate most with the IBS symptom scale (GSRS-IBS) and Quality of life (IBS-QoL). They will be used as the dependent variables in multiple linear regression analysis with the other parameters as independent variables.
Part 2 and 3
Study design:
Randomized controlled clinical trial.
Study population:
Patients will then be randomized to either iCBT (80 patients), Low FODMAP diet (80 patients) or control group (40 patients) (2:2:1 randomization). The control group will wait 10 weeks before being randomised to treatment with either iCBT (20 patients) or low FODMAP diet (20 patients).
Treatments:
iCBT and Low FODMAP diet (see below).
Analysis:
Treatment efficacy analysis using linear mixed models on the primary outcome measures with time as within-subject factor (random intercept random slope models) and group as between-subject factor, with the time-by-group interaction effect testing the hypothesis of a stronger response to treatment compared to waiting list control. Continuous variables will be used to maximize power. Within-person correlations between IBS features. Linear mixed models and latent class growth analysis to establish which baseline parameters of IBS predict the treatment effect on the GSRS-IBS and IBS-QoL. Cross-lagged panel models to investigate the temporal order of change in the different outcome variables, while controlling for stabilities over time and cross-sectional correlations.
Part 4
Comparison of psychological and dietary treatment in IBS patients. At this point the investigators will have 100 patients who were treated with ICBT and 100 patients who were treated with low-FODMAP diet. Treatment efficacy will be analyzed using linear mixed models on the primary outcome measures with time as within-subject factor (random intercept random slope models) and group as between-subject factor, with the time-by-group interaction effect testing the hypothesis of a stronger response to iCBT compared to low-FODMAP.
Power calculation:
It is estimated that 100 participants per group need to be included in the treatment studies and the analysis of predictors of treatment responses with regard to a dropout rate of 10% (part 2-4). For part 1, the analysis can be performed on the entire study population of 200 participants, which gives 90% power to be able to detect an effect size (Cohen's f² = 0.10) in multiple regression analysis with 9 independent variables (derived from questionnaire PHQ-9, GAD-7, PHQ-12, VSI, IBS-BRQ and NEO-FFI) predicting the severity of IBS symptoms (IBS-SSS and GSRS-IBS) and quality of life (IBS-QoL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study design is an open labelled, randomized, controlled clinical trial, with a ratio 2:2:1.
| Arm | Type | Receives |
|---|---|---|
| Internet based cognitive behavioral therapy group | Experimental | Behavioral: Internet based cognitive behavioral therapy.80 patients will be randomized to receive iCBT. Psychological therapy is effective in IBS patients. The treatment takes 10 weeks and is divided into five successive steps. Patients have to report that they have worked through a treatment step to get access to the next. The patients will be encouraged to work through steps 1-4 during the first half of the treatment and to spend the latter half of the treatment on step 5, in which exposure exercises are introduced. A psychologist/CBT therapist will manage the online therapeutic contact with the patients. |
| Low FODMAP group | Experimental | Dietary Supplement: Low FODMAP diet therapy80 patients will then be randomized to receive Low FODMAP diet. FODMAPs (Fermentable Oligosaccharides, Disaccharides, Monosaccharides And Polyols) are poorly absorbed short-chain carbohydrates including fructose (in excess of glucose), lactose, polyols, fructans and galacto-oligosaccharides. The concept of considering all these molecules collectively as a treatment for IBS is relatively new. Understanding of FODMAPs comprises mechanisms of action such as luminal distension from their osmotic effect and rapid fermentation to hydrogen. These findings have led to increased application of the low FODMAP diet to manage IBS symptoms. Treatment will undergo 10 weeks supervised monotherapy with low FODMAP diet. This will be done with the help of professional dieticians in Örebro region, who will meet the patients and inform them how this diet works as well as follow up. |
| Control group | Active comparator | Behavioral: Internet based cognitive behavioral therapy., Dietary Supplement: Low FODMAP diet therapyThe control Group (40 patients) will wait for 10 weeks before being randomised to treatment with either iCBT or low FODMAP diet. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- IBS symptom severity score of at least 175 (moderate to severe symptoms).
- Age 18 to 65 years.
Key exclusion criteria (8 listed)
- Abnormal results on standard screening laboratory tests; this means that patients with abnormal thyroid-stimulating hormone (TSH), increased f-calprotectin or positive celiac disease serology will not be included.
- Severe psychiatric, systemic inflammatory diseases, inflammatory bowel disease and other severe diseases such as cancer.
- Current drug or alcohol abuse.
- Inability to complete questionnaires in Swedish.
- Current pharmacological treatment for their IBS symptoms, except for "over the counter" products such as loperamide or fiber.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet based cognitive behavioral therapy.Patients will receive iCBT for 10 weeks, divided into five successive steps. The iCBT will be guided by online therapists and emphasizes acceptance of symptoms through exposure training. Patients have to report that they have worked through a treatment step to get access to the next. Patients will be encouraged to work through steps 1-4 during the first half of the treatment and to spend the latter half on step 5, in which exposure exercises will be introduced. The treatment aims to break the vicious cycle between avoidance behavior, symptom severity and functional impairment. | Behavioural | Control group, Internet based cognitive behavioral therapy group |
| Low FODMAP diet therapyPatients will receive 10 weeks of standardized treatment with low FODMAP diet consisting of 3 stages: FODMAP restriction; FODMAP reintroduction and FODMAP personalization. These stages will be covered in at least three appointments by primary care dieticians in Region Örebro County. | Dietary supplement | Control group, Low FODMAP group |
Primary outcome
Gastrointestinal Symptom Rating Scale-IBS (GSRS-IBS)
Time frame: 10 weeks
Measures disease-specific symptoms in IBS patients
The IBS quality of life questionnaire (IBS-QoL)
Time frame: 10 weeks
Assessment of disease-specific quality of Life
10 secondary outcomes
Patient Health Questionnaire Anxiety module (GAD-7)
Time frame: 10 weeks
Patient Health Questionnaire Depression Module (PHQ-9)
Time frame: 10 weeks
Patient Health Questionnaire Somatic symptom severity ('somatization') module (PHQ-12)
Time frame: 10 weeks
Visceral Sensitivity Index (VSI) questionnaire
Time frame: 10 weeks
The Irritable Bowel Syndrome-Behavioural Responses Questionnaire (IBSBRQ)
Time frame: 10 weeks
Nepean Dyspepsia Index (NDI)
Time frame: 10 weeks
IBS severity scoring system (IBS-SSS)
Time frame: 10 weeks
Rome IV diagnostic questionnaire
Time frame: 10 weeks
The Neuroticism-Extraversion-Openness Five Factor Inventory-3 (NEO-FFI-3) questionnaire
Time frame: 10 weeks
Bristol Stool Form Scale
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet based cognitive behavioral therapy. and Low FODMAP diet therapy in people with Irritable Bowel Syndrome, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Al-Ahmadi, MD (0046739083380, ahmed.al-ahmadi@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal Symptom Rating Scale-IBS (GSRS-IBS) (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.