About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.)
Trial design
Treatments tested in this trial
- Psyllium
- Sauerkraut
- Fresh apples
- Dried apples
Treatment groups
Sponsors and collaborators
Institute of Nutrition, Slovenia (Nutris)
Lead sponsor
University Medical Centre Ljubljana
Collaborator
University of Ljubljana
Collaborator