Constipation - FunctionalNCT05447481
Evaluation of the Effect of Chicory Inulin-type Fructans in Constipated Adults
A study testing chicory inulin-type fructan in people with Constipation - Functional, run by Sensus.
Trial summary
Constipation is common in the general population, especially in women and in the elderly, which can significantly affect quality of life of the individual. There is a general consumer trend to seek natural food options, also when addressing health issues such as constipation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- chicory inulin-type fructan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2015to 28 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give written informed consent
- Between 18 and 75 years of age
- Have functional constipation according to the Rome III Diagnostic Criteria
- Subjects were to continue on their normal diet and agreed to not take probiotic or prebiotic products/supplements and supplemental dietary fibres for the duration of the study
- The subject agrees to complete the Patient Diary for two weeks prior to study entry and for the duration of the study
- Subject is in general good health as determined by the investigator.
Who cannot join
- Subjects less than 18 and greater than 75 years of age
- Females who are pregnant, lactating or wish to become pregnant during the study.
- Subjects who are hypersensitive to any of the components of the test product,
- Subjects who have an obstructive or metabolic aetiology for constipation,
- Subjects who have a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative),
- Subjects currently taking supplemental dietary fibres or have taken them within two weeks of the screening visit,
- Subjects who are taking a probiotic or prebiotic product/supplement or had taken them within two weeks of the screening visit
About this study
Official title: A Randomized Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Effects of Chicory Inulin-type Fructans in Adults With Functional Constipation
Constipation is common in the general population, especially in women and in the elderly, which can significantly affect quality of life of the individual. There is a general consumer trend to seek natural food options, also when addressing health issues such as constipation. Consumers seek tasty options and there is a paucity of tasty functional foods to address constipation. Adding natural fiber to food, like inulin-type fructans from chicory root fiber, can increase fiber intake and potentially prevent or resolve constipation issues. This study aimed to increase the body of scientific data on inulin-type fructans by way of a randomized, placebo-controlled, cross-over study. Maltodextrin was used as the placebo in this study.
- Conditions
- Constipation - Functional
- Being tested
- chicory inulin-type fructan
- Keywords
- adults, functional constipation, inulin-type fructans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chicory inulin-type fructanDietary supplement
Dietary supplement: chicory inulin-type fructan
| Study group | Role | What they receive |
|---|---|---|
| Chicory inulin-type fructan - placebo | Experimental | Dietary supplement: chicory inulin-type fructan Placebo: maltodextrin Receives: Dietary Supplement: chicory inulin-type fructan |
| Placebo - chicory inulin-type fructan | Experimental | Placebo: maltodextrin Dietary Supplement: chicory inulin-type fructan Receives: Dietary Supplement: chicory inulin-type fructan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in stool frequency
Determine the impact of chicory inulin-type fructan on stool frequency in constipated subjects.
Measured: During the 12 week intervention period
Secondary outcomes (6)
Change in stool consistency
Determine the effect of chicory inulin-type fructans on stool consistency in constipated subjects.
Measured: During the 12 week intervention period
Patient Assessment of Constipation Symptoms
Determine the effect of chicory inulin-type fructans on constipation symptoms using the Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire.
Measured: During the 12 week intervention period
Quality of life using the PAC-QOL questionnaire
Determine the effect of chicory inulin-type fructans on quality of life using the PAC-QOL questionnaire
Measured: During the 12 week intervention period
Physical activity
Determine the physical activity of the subjects using the International Physical Activity Questionnaire (IPAQ)
Measured: During the 12 week intervention period
Resort to laxatives
Determine the resort to laxatives of the subjects
Measured: During the 12 week intervention period
Gut microbiota composition
Determine the effect of chicory inulin-type fructans on gut microbiota composition
Measured: During the 12 week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start11 Nov 2015
- Primary completion28 Jul 2016
- Study completion28 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Constipation - FunctionalStudies 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
- Crossover
- Model description
- This was a randomized, double-blind, placebo-controlled, cross-over study to evaluate the effects of chicory inulin-type fructans in adults with functional constipation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensus
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, Wageningen University
- Responsible party
- Sponsor
- Investigators
- Elaine E Vaughan, PhD, Study chair, Sensus BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05447481
- Sponsor's protocol ID
- AFCRO-058
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Puhlmann ML, Wegh CAM, van der Zalm SCC, Dam V, Doolan A, Meyer D, Belzer C, Vaughan EE, Benninga MA, Smidt H. Inulin-induced improvements on bowel habit and gut microbiota in adults with functional constipation: findings of a randomized, double-blind, placebo-controlled study. BMC Gastroenterol. 2025 Nov 13;25(1):806. doi: 10.1186/s12876-025-04409-6.
PubMed 41233756
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind, Placebo-controlled, Cross-over Study to Evaluate the Effects of Chicory Inulin-type Fructans in Adults With Functional Constipation
- ClinicalTrials.gov ID
- NCT05447481
- Acronym / sponsor ID
- AFCRO-058
- Conditions
- Constipation - Functional
- Keywords
- adults, functional constipation, inulin-type fructans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- SensusIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, Wageningen University
- Study start
- 11 Nov 2015 (actual)
- Primary completion
- 28 Jul 2016 (actual)
- Study completion
- 28 Jul 2016 (actual)
- First posted
- 7 Jul 2022 (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.
Constipation is common in the general population, especially in women and in the elderly, which can significantly affect quality of life of the individual. There is a general consumer trend to seek natural food options, also when addressing health issues such as constipation. Consumers seek tasty options and there is a paucity of tasty functional foods to address constipation. Adding natural fiber to food, like inulin-type fructans from chicory root fiber, can increase fiber intake and potentially prevent or resolve constipation issues. This study aimed to increase the body of scientific data on inulin-type fructans by way of a randomized, placebo-controlled, cross-over study. Maltodextrin was used as the placebo in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This was a randomized, double-blind, placebo-controlled, cross-over study to evaluate the effects of chicory inulin-type fructans in adults with functional constipation.
| Arm | Type | Receives |
|---|---|---|
| Chicory inulin-type fructan - placebo | Experimental | Dietary Supplement: chicory inulin-type fructanDietary supplement: chicory inulin-type fructan Placebo: maltodextrin |
| Placebo - chicory inulin-type fructan | Experimental | Dietary Supplement: chicory inulin-type fructanPlacebo: maltodextrin Dietary Supplement: chicory inulin-type fructan |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to give written informed consent
- Between 18 and 75 years of age
- Have functional constipation according to the Rome III Diagnostic Criteria
- Subjects were to continue on their normal diet and agreed to not take probiotic or prebiotic products/supplements and supplemental dietary fibres for the duration of the study
- The subject agrees to complete the Patient Diary for two weeks prior to study entry and for the duration of the study
Key exclusion criteria (7 listed)
- Subjects less than 18 and greater than 75 years of age
- Females who are pregnant, lactating or wish to become pregnant during the study.
- Subjects who are hypersensitive to any of the components of the test product,
- Subjects who have an obstructive or metabolic aetiology for constipation,
- Subjects who have a history of laxative abuse (greater than the daily dosage recommended on the label for any laxative),
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 |
|---|---|---|
| chicory inulin-type fructanDietary supplement: chicory inulin-type fructan | Dietary supplement | Chicory inulin-type fructan - placebo, Placebo - chicory inulin-type fructan |
Primary outcome
Change in stool frequency
Time frame: During the 12 week intervention period
Determine the impact of chicory inulin-type fructan on stool frequency in constipated subjects.
6 secondary outcomes
Change in stool consistency
Time frame: During the 12 week intervention period
Patient Assessment of Constipation Symptoms
Time frame: During the 12 week intervention period
Quality of life using the PAC-QOL questionnaire
Time frame: During the 12 week intervention period
Physical activity
Time frame: During the 12 week intervention period
Resort to laxatives
Time frame: During the 12 week intervention period
Gut microbiota composition
Time frame: During the 12 week intervention period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- Derived from this study: PubMed 41233756Puhlmann ML, Wegh CAM, van der Zalm SCC, Dam V, Doolan A, Meyer D, Belzer C, Vaughan EE, Benninga MA, Smidt H. Inulin-induced improvements on bowel habit and gut microbiota in adults with functional constipation: findings of a randomized, double-blind, placebo-controlled study. BMC Gastroenterol. 2025 Nov 13;25(1):806. doi: 10.1186/s12876-025-04409-6.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Elaine E Vaughan, PhD study chair
Sensus BV
Questions about this trial
What is this clinical trial studying?
A study testing chicory inulin-type fructan in people with Constipation - Functional, run by Sensus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. 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: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in stool frequency (time frame: During the 12 week intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05447481, which also lists 1 linked publication.
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 7 Jul 2022.