Functional Constipation, Irritable Bowel Syndrome
Conditions
Brief summary
The effects of different foods to normal bowel function in adult population will be investigated. A randomised controlled intervention trial will be conducted on about 120 (30 per group) adult (18-70 years) subjects with functional constipation and irritable bowel syndrome with constipation according to the IV. Rome criteria. At least one week before inclusion in the study, patients will stop taking laxatives and other anti-constipation medications. Subjects will be randomly selected to consume one of the test foods (fresh apples, dried apples, sauerkraut) or the active control (psyllium) in the equivalent amount of 3 g of fiber per day for 4 weeks. Subjects will be asked not to change their lifestyle habits, such as diet and physical activity level, and not to take oral laxatives during the period of participation in the study.
Interventions
OTHERPsyllium
Participants will once daily consume predefined amount of psyllium, corresponding to 3 g of dietary fibre, for 28 days.
OTHERSauerkraut
Participants will once daily consume predefined amount of sauerkraut, corresponding to 3 g of dietary fibre, for 28 days.
OTHERFresh apples
Participants will once daily consume predefined amount of fresh apples, corresponding to 3 g of dietary fibre, for 28 days.
OTHERDried apples
Participants will once daily consume predefined amount of dried apples, corresponding to 3 g of dietary fibre, for 28 days.
Sponsors
University Medical Centre Ljubljana
University of Ljubljana
Institute of Nutrition, Slovenia (Nutris)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Intervention include consumption of specific foods, therefore masking to participant and investigatior is not possible. Collected data will be masked for accessor of outcomes.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Inclusion criteria: * Signed informed consent of the participant to participate in the study * Age between 18 and 70 years * Functional constipation or irritable bowel syndrome * Expressed willingness to eat the investigated food daily (sauerkraut, apples, dried apples or psyllium; period of four weeks) 2.
Exclusion criteria
* Known allergy to the investigated foods (fresh apples, dried apples, sauerkraut or psyllium) * Pregnancy or breastfeeding * Previous gastrointestinal surgery with the exception of cholecystectomy and appendectomy * Other gastrointestinal diseases (chronic inflammatory bowel disease, celiac disease, gastroparesis, etc.) * Serious chronic diseases * Introduction of extensive changes in diet or physical activity in the last 4 weeks before the inclusion examination * Regular use of laxatives or inability to stop using laxatives for the duration of the study * Concurrent participation in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in frequency of complete spontaneous bowel movements (CSBM) / week | fourth week vs pre-intervention | Daily measurement of number of complete spontaneous bowel movements |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in constipation symptom score (CSC) | fourth week vs pre-intervention | Measurement with constipation symptom score (0-48 points, higher SCS score mean more severe symptoms) |
| Change in stool consistency using Bristol stool form (BSF) scale | fourth week vs pre-intervention | Measurement with Bristol stool form (BSF) scale (Type 1: Separate hard lumps, like nuts (difficult to pass), Type 2: Sausage-shaped, but lumpy, Type 3: Like a sausage but with cracks on its surface, Type 4: Like a sausage or snake, smooth and soft (average stool), Type 5: Soft blobs with clear cut edges, Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea), Type 7: Watery, no solid pieces, entirely liquid (diarrhea)) |
| Change in blood lipids | in week after intervention vs pre-intervention | Laboratory measuremnt of S-Cholesterol, S-HDL-Cholesterol, S-LDL-Cholesterol and S-Triglycerides |
Countries
Slovenia
Contacts
Primary ContactAnita Kušar, PhD
Backup ContactIgor Pravst, PhD
Outcome results
None listed