An interventional study of Psyllium and Sauerkraut in Functional Constipation and Irritable Bowel Syndrome, sponsored by Nutrition Institute, Slovenia. Not yet recruiting at 1 site in Slovenia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-21.
Sponsored by Nutrition Institute, Slovenia · Not applicable, Interventional, and Treatment
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.
Signed informed consent of the participant to participate in the study
Known allergy to the investigated foods (fresh apples, dried apples, sauerkraut or psyllium)
Psyllium containing 3 g dietary fibre, daily, for 4 weeks
Other: Psyllium
Sauerkraut containing 3 g dietary fibre, daily, for 4 weeks
Other: Sauerkraut
Fresh apples containing 3 g dietary fibre, daily, for 4 weeks
Other: Fresh apples
Dried apples containing 3 g dietary fibre, daily, for 4 weeks
Other: Dried apples
Participants will once daily consume predefined amount of psyllium, corresponding to 3 g of dietary fibre, for 28 days.
Participants will once daily consume predefined amount of sauerkraut, corresponding to 3 g of dietary fibre, for 28 days.
Participants will once daily consume predefined amount of fresh apples, corresponding to 3 g of dietary fibre, for 28 days.
Participants will once daily consume predefined amount of dried apples, corresponding to 3 g of dietary fibre, for 28 days.
Change in frequency of complete spontaneous bowel movements (CSBM) / week
Daily measurement of number of complete spontaneous bowel movements
Time frame: fourth week vs pre-intervention
Change in constipation symptom score (CSC)
Measurement with constipation symptom score (0-48 points, higher SCS score mean more severe symptoms)
Time frame: fourth week vs pre-intervention
Change in stool consistency using Bristol stool form (BSF) scale
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))
Time frame: fourth week vs pre-intervention
Change in blood lipids
Laboratory measuremnt of S-Cholesterol, S-HDL-Cholesterol, S-LDL-Cholesterol and S-Triglycerides
Time frame: in week after intervention vs pre-intervention
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Nutrition Institute, Slovenia