Functional ConstipationNutriPlantNCT06785831
NutriPlant - Opportunities for Increasing Consumption of Local Fruits and Vegetables
A study testing Psyllium, Sauerkraut and Fresh apples in people with Functional Constipation and Irritable Bowel Syndrome, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functional Constipation, Irritable Bowel Syndrome
- What is being tested?
- Psyllium, Sauerkraut and Fresh apples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 Jan 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site
UKC Ljubljana
Ljubljana, 1000
Darko Siuka, PhD, +486 1 522 26 39, darko.siuka@kclj.si
Borut Štabuc, PhD
About this study
Official title: Opportunities for Increasing Consumption of Local Fruits and Vegetables in Slovenian Population (NutriPlant)
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.
- Conditions
- Functional Constipation, Irritable Bowel Syndrome
- Being tested
- Psyllium, Sauerkraut, Fresh apples, Dried apples
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsylliumOther
Participants will once daily consume predefined amount of psyllium, corresponding to 3 g of dietary fibre, for 28 days.
SauerkrautOther
Participants will once daily consume predefined amount of sauerkraut, corresponding to 3 g of dietary fibre, for 28 days.
Fresh applesOther
Participants will once daily consume predefined amount of fresh apples, corresponding to 3 g of dietary fibre, for 28 days.
Dried applesOther
Participants will once daily consume predefined amount of dried apples, corresponding to 3 g of dietary fibre, for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Psyllium | Active comparator | Psyllium containing 3 g dietary fibre, daily, for 4 weeks Receives: Other: Psyllium |
| Sauerkraut | Experimental | Sauerkraut containing 3 g dietary fibre, daily, for 4 weeks Receives: Other: Sauerkraut |
| Fresh apples | Experimental | Fresh apples containing 3 g dietary fibre, daily, for 4 weeks Receives: Other: Fresh apples |
| Dried apples | Experimental | Dried apples containing 3 g dietary fibre, daily, for 4 weeks Receives: Other: Dried apples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frequency of complete spontaneous bowel movements (CSBM) / week
Daily measurement of number of complete spontaneous bowel movements
Measured: fourth week vs pre-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Centre Ljubljana, University of Ljubljana
- Responsible party
- Sponsor
- Investigators
- Anita Kušar, PhD, Study director, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785831
- Sponsor's protocol ID
- KME 0120-242/2024-2711-4
- Other IDs
- L7-50154, L7-50154
- Acronym
- NutriPlant
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2024
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opportunities for Increasing Consumption of Local Fruits and Vegetables in Slovenian Population (NutriPlant)
- ClinicalTrials.gov ID
- NCT06785831
- Acronym / sponsor ID
- NutriPlant / KME 0120-242/2024-2711-4
- Conditions
- Functional Constipation, Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institute of Nutrition, Slovenia (Nutris)University, hospital or other
- Collaborators
- University Medical Centre Ljubljana, University of Ljubljana
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Psyllium | Active comparator | Other: PsylliumPsyllium containing 3 g dietary fibre, daily, for 4 weeks |
| Sauerkraut | Experimental | Other: SauerkrautSauerkraut containing 3 g dietary fibre, daily, for 4 weeks |
| Fresh apples | Experimental | Other: Fresh applesFresh apples containing 3 g dietary fibre, daily, for 4 weeks |
| Dried apples | Experimental | Other: Dried applesDried apples containing 3 g dietary fibre, daily, for 4 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsylliumParticipants will once daily consume predefined amount of psyllium, corresponding to 3 g of dietary fibre, for 28 days. | Other | Psyllium |
| SauerkrautParticipants will once daily consume predefined amount of sauerkraut, corresponding to 3 g of dietary fibre, for 28 days. | Other | Sauerkraut |
| Fresh applesParticipants will once daily consume predefined amount of fresh apples, corresponding to 3 g of dietary fibre, for 28 days. | Other | Fresh apples |
| Dried applesParticipants will once daily consume predefined amount of dried apples, corresponding to 3 g of dietary fibre, for 28 days. | Other | Dried apples |
Primary outcome
Change in frequency of complete spontaneous bowel movements (CSBM) / week
Time frame: fourth week vs pre-intervention
Daily measurement of number of complete spontaneous bowel movements
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anita Kušar, PhD study director
Researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psyllium, Sauerkraut and Fresh apples in people with Functional Constipation and Irritable Bowel Syndrome, run by Institute of Nutrition, Slovenia (Nutris) at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anita Kušar, PhD (0038659068870, anita.kusar@nutris.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frequency of complete spontaneous bowel movements (CSBM) / week (time frame: fourth week vs pre-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.