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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 March 2021 |
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Main ID: |
NCT04770883 |
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Date of registration:
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22/02/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Psychological and Dietary Treatment in IBS
ROLIBS |
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Scientific title:
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Phenotyping and Treatment of Primary Health Care IBS Patients. A Randomized Controlled Trial |
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Date of first enrolment:
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March 1, 2021 |
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Target sample size:
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200 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04770883 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Ahmed Al-Ahmadi, MD |
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Address:
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Telephone:
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0046739083380 |
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Email:
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ahmed.al-ahmadi@regionorebrolan.se |
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Affiliation:
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Name:
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Ahmed Al-Ahmadi, MD |
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Address:
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Telephone:
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0046739083380 |
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Email:
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ahmed.al-ahmadi@regionorebrolan.se |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. IBS symptom severity score of at least 175 (moderate to severe symptoms).
2. Age 18 to 65 years.
Exclusion Criteria:
1. 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.
2. Severe psychiatric, systemic inflammatory diseases, inflammatory bowel disease and
other severe diseases such as cancer.
3. Current drug or alcohol abuse.
4. Inability to complete questionnaires in Swedish.
5. Current pharmacological treatment for their IBS symptoms, except for "over the
counter" products such as loperamide or fiber.
6. 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.
7. Current psychological treatment.
8. Current psychological treatment.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Irritable Bowel Syndrome
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Intervention(s)
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Behavioral: Internet based cognitive behavioral therapy.
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Dietary Supplement: Low FODMAP diet therapy
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Primary Outcome(s)
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Gastrointestinal Symptom Rating Scale-IBS (GSRS-IBS)
[Time Frame: 10 weeks]
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The IBS quality of life questionnaire (IBS-QoL)
[Time Frame: 10 weeks]
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Secondary Outcome(s)
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Bristol Stool Form Scale
[Time Frame: 10 weeks]
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IBS severity scoring system (IBS-SSS)
[Time Frame: 10 weeks]
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Nepean Dyspepsia Index (NDI)
[Time Frame: 10 weeks]
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Patient Health Questionnaire Anxiety module (GAD-7)
[Time Frame: 10 weeks]
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Patient Health Questionnaire Depression Module (PHQ-9)
[Time Frame: 10 weeks]
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Patient Health Questionnaire Somatic symptom severity ('somatization') module (PHQ-12)
[Time Frame: 10 weeks]
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Rome IV diagnostic questionnaire
[Time Frame: 10 weeks]
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The Irritable Bowel Syndrome-Behavioural Responses Questionnaire (IBSBRQ)
[Time Frame: 10 weeks]
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The Neuroticism-Extraversion-Openness Five Factor Inventory-3 (NEO-FFI-3) questionnaire
[Time Frame: 10 weeks]
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Visceral Sensitivity Index (VSI) questionnaire
[Time Frame: 10 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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