Evaluation of tolerance and adherence to a low-FODMAP diet with spelt compared to a previous standard low-FODMAP diet without spelt in people with irritable bowel syndrome: a controlled randomised cross-over trial.
Phase 4
- Conditions
- ow FODMAP diet for patients with irritable bowel syndrome (IBS)K58Irritable bowel syndrome
- Registration Number
- DRKS00028991
- Lead Sponsor
- Ikaneum am Israelitischen Krankenhaus
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
Age = 18 years
- Patients with irritable bowel syndrome (diagnosis under exclusion of other possible causes, such as lactose intolerance or chronic inflammatory bowel diseases, such as Crohn's disease) or suspicion of RDS or unclear abdominal complaints
- No planned holiday < 7 days during the study period (01.05.2022 to 18.09.2022).
Exclusion Criteria
- Pregnancy or breastfeeding
- Small intestinal obstruction (SIBO)
- Tumour diseases (haematological, solid)
- Other severe organ diseases
- Diagnosed psychiatric illnesses (bipolar disorder, severe depression, etc...)
- Treatment/previous treatment for an eating disorder
- Cognitive impairment/mental retardation
- Nutritionists
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method FD - D vs. LFD + D: Comparison points Visual Analog Scale from FIS-Q (mean value from 4 queries)
- Secondary Outcome Measures
Name Time Method - Comparison Pre-post delta IBS-QoL <br>- Comparison of pre-post delta DASS-D (depression), DASS-A (anxiety) and DASS-S (stress), additionally LFD - D vs. LFD + D <br>- Correlation of FIS-Q with basal DASS-D, DASS-A and DASS-S; additional comparison of FIS-Q in participants with and without symptoms of anxiety, depression or stress, as well as during the course of the study. <br>- Correlation basal IBS-SS / DASS D/A/S and over time <br>- Group comparison of delta IBS-SSS overall and in participants with and without anxiety, depression, or stress symptoms <br>- Descriptive presentation of the results from the Likert scales, additionally LFD - D vs. LFD + D <br>