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.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 896 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Nutrition Institute, Slovenia is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Signed of the participant to participate in the study
Known allergy to the investigated foods (fresh apples, dried apples, sauerkraut or psyllium)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Start is estimated for Jan 2025; primary completion for Sep 2025, 7 months later.
Of 305 non-industry interventional studies with no phase under Irritable Bowel Syndrome, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's planned 7 months is below that.
Counting every sponsor, half of 357 studies reached it within 19 months; a quarter within 9 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nutrition Institute, Slovenia