Gut HealthPhase 2NCT01656499
Effect of AXOS on the Colon Metabolism in Healthy Volunteers
A Phase 2 study testing Arabinoxylanoligosaccharides and Maltodextrine in people with Gut Health, run by KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the effect of AXOS on parameters of colon metabolism and gut health Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Health
- What is being tested?
- Arabinoxylanoligosaccharides and Maltodextrine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2011to Sep 2012
- Phase
- Phase 2
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
- regular dietary pattern (3 meals/day)
- age: 18-45y
- BMI: 18,5-27 kg/m2
Who cannot join
- intake of antibiotics 1 month prior to the study
- abdominal surgery in the past, with the exception of appendectomy
- intake of medication influencing the gastro-intestinal system 14 days prior to the study
- in treatment at a dietician
- serious liver- or kidney failure
- vegetarians
- intake of pre- and/or probiotics
- Exposure to radioactivity 1 year prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the effect of AXOS on parameters of colon metabolism and gut health
- Conditions
- Gut Health
- Being tested
- Arabinoxylanoligosaccharides, Maltodextrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArabinoxylanoligosaccharidesDietary supplement
MaltodextrineDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Arabinoxylanoligosaccharides (AXOS) | Active comparator | AXOS (2 x 5g WBE/day) Receives: Dietary Supplement: Arabinoxylanoligosaccharides |
| Maltodextrine (placebo) | Placebo comparator | Maltodextrine (2 x 5g/day) Receives: Dietary Supplement: Maltodextrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal water toxicity
Measured: Participants are followed for 10 weeks, with measurements on 4 specific time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut HealthStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Verbeke, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656499
- Sponsor's protocol ID
- ML7245
- Status last verified
- Jan 2015
- First submitted
- 30 Jul 2012
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of AXOS on the Colon Metabolism in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01656499
- Acronym / sponsor ID
- ML7245
- Conditions
- Gut Health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 Aug 2012 (estimated)
- 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 purpose of this study is to evaluate the effect of AXOS on parameters of colon metabolism and gut health
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arabinoxylanoligosaccharides (AXOS) | Active comparator | Dietary Supplement: ArabinoxylanoligosaccharidesAXOS (2 x 5g WBE/day) |
| Maltodextrine (placebo) | Placebo comparator | Dietary Supplement: MaltodextrineMaltodextrine (2 x 5g/day) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy volunteers
- regular dietary pattern (3 meals/day)
- age: 18-45y
- BMI: 18,5-27 kg/m2
Key exclusion criteria (8 listed)
- intake of antibiotics 1 month prior to the study
- abdominal surgery in the past, with the exception of appendectomy
- intake of medication influencing the gastro-intestinal system 14 days prior to the study
- in treatment at a dietician
- serious liver- or kidney failure
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 |
|---|---|---|
| Arabinoxylanoligosaccharides | Dietary supplement | Arabinoxylanoligosaccharides (AXOS) |
| Maltodextrine | Dietary supplement | Maltodextrine (placebo) |
Primary outcome
Fecal water toxicity
Time frame: Participants are followed for 10 weeks, with measurements on 4 specific time points
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 14 Jan 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Arabinoxylanoligosaccharides and Maltodextrine in people with Gut Health, run by KU Leuven at 1 site in Belgium.
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 4 inclusion and 8 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 14 Jan 2015. 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 Belgium. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Fecal water toxicity (time frame: Participants are followed for 10 weeks, with measurements on 4 specific time points). 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 14 Jan 2015.