Gastrointestinal HealthNCT01001949
In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects (Juniors)
A study testing Wheat Bran Extract in people with Gastrointestinal Health and Healthy Subjects, run by Fugeia NV at 1 site in Belgium.
Trial summary
The investigational product used in this study is a soft drink containing an arabinoxylan-oligosaccharide (AXOS) preparation extracted from wheat bran (hereafter called Wheat Bran Extract, WBE). Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Health, Healthy Subjects
- What is being tested?
- Wheat Bran Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2009to Oct 2009
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- regular eating habits
- consent to take in the study product according to the study protocol
- consent of parents for follow-up of the protocol
- subject is willing to maintain his/her habitual food and beverage intake throughout the study period (with the exception of omission of prebiotic and probiotic food products as indicated in the study protocol)
Who cannot join
- low-calorie diet or other extreme dietary habits in the 6 weeks before the start of the clinical trial
- recent use of antibiotics
- abdominal surgery in the past
- use of medication or dietary supplements known to influence gastrointestinal tract within two weeks of start of clinical trial. Examples of such medication/dietary supplements are antispasmodics, anti-diarrhea medication and/or probiotic medication
- serious illness within 3 months of start of clinical trial
- chronic gastrointestinal conditions such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), chronic constipation, history of frequent diarrhea, clinically important lactose intolerance
Show all 10Show fewer
- complete anesthetics within 3 month of the start of the clinical trial
- allergy for wheat products
- celiac disease
- Subject has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the subject at undue risk
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Gastrointestinal Research, Laboratory Digestion and Absorption
Leuven, 3000
About this study
Official title: In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects: a Randomized, Placebo-controlled, Double-blind, Cross-over Study
The investigational product used in this study is a soft drink containing an arabinoxylan-oligosaccharide (AXOS) preparation extracted from wheat bran (hereafter called Wheat Bran Extract, WBE).
The objective of this study is to analyze the effect of the intake of WBE on various parameters of gastrointestinal health in children (8-12 yrs). Additionally, safety was analyzed using treatment emergent Adverse Events (AEs).
- Conditions
- Gastrointestinal Health, Healthy Subjects
- Being tested
- Wheat Bran Extract, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheat Bran ExtractDietary supplement
soft drink comprising WBE and natural flavor and coloring agent, ingestion after breakfast and after dinner
placeboDietary supplement
soft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and dinner
| Study group | Role | What they receive |
|---|---|---|
| Wheat Bran Extract | Experimental | Not described Receives: Dietary Supplement: Wheat Bran Extract |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bifidobacteria content in feces
Measured: day 19 or 20 of each intervention period
butyric acid content in feces
Measured: day 19 or 20 of each intervention period
stool frequency
Measured: third week of each intervention period
Secondary outcomes (1)
adverse events
Measured: whole study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionOct 2009
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 Gastrointestinal HealthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fugeia NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Willem Broekaert, Ph.D., Study director, Fugeia NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001949
- Sponsor's protocol ID
- ML5282 junior
- Status last verified
- Oct 2009
- First submitted
- 26 Oct 2009
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Francois IE, Lescroart O, Veraverbeke WS, Marzorati M, Possemiers S, Hamer H, Windey K, Welling GW, Delcour JA, Courtin CM, Verbeke K, Broekaert WF. Effects of wheat bran extract containing arabinoxylan oligosaccharides on gastrointestinal parameters in healthy preadolescent children. J Pediatr Gastroenterol Nutr. 2014 May;58(5):647-53. doi: 10.1097/MPG.0000000000000285.
PubMed 24368315
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects: a Randomized, Placebo-controlled, Double-blind, Cross-over Study
- ClinicalTrials.gov ID
- NCT01001949
- Acronym / sponsor ID
- ML5282 junior
- Conditions
- Gastrointestinal Health, Healthy Subjects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Fugeia NVIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 27 Oct 2009 (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 investigational product used in this study is a soft drink containing an arabinoxylan-oligosaccharide (AXOS) preparation extracted from wheat bran (hereafter called Wheat Bran Extract, WBE).
The objective of this study is to analyze the effect of the intake of WBE on various parameters of gastrointestinal health in children (8-12 yrs). Additionally, safety was analyzed using treatment emergent Adverse Events (AEs).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wheat Bran Extract | Experimental | Dietary Supplement: Wheat Bran Extract |
| placebo | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- regular eating habits
- consent to take in the study product according to the study protocol
- consent of parents for follow-up of the protocol
- subject is willing to maintain his/her habitual food and beverage intake throughout the study period (with the exception of omission of prebiotic and probiotic food products as indicated in the study protocol)
Key exclusion criteria (10 listed)
- low-calorie diet or other extreme dietary habits in the 6 weeks before the start of the clinical trial
- recent use of antibiotics
- abdominal surgery in the past
- use of medication or dietary supplements known to influence gastrointestinal tract within two weeks of start of clinical trial. Examples of such medication/dietary supplements are antispasmodics, anti-diarrhea medication and/or probiotic medication
- serious illness within 3 months of start of clinical trial
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 |
|---|---|---|
| Wheat Bran Extractsoft drink comprising WBE and natural flavor and coloring agent, ingestion after breakfast and after dinner | Dietary supplement | Wheat Bran Extract |
| placebosoft drink with natural flavor and coloring agent, without WBE, ingestion after breakfast and dinner | Dietary supplement | placebo |
Primary outcome
Bifidobacteria content in feces
Time frame: day 19 or 20 of each intervention period
butyric acid content in feces
Time frame: day 19 or 20 of each intervention period
stool frequency
Time frame: third week of each intervention period
1 secondary outcome
adverse events
Time frame: whole study 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 27 Oct 2009.
- Derived from this study: PubMed 24368315Francois IE, Lescroart O, Veraverbeke WS, Marzorati M, Possemiers S, Hamer H, Windey K, Welling GW, Delcour JA, Courtin CM, Verbeke K, Broekaert WF. Effects of wheat bran extract containing arabinoxylan oligosaccharides on gastrointestinal parameters in healthy preadolescent children. J Pediatr Gastroenterol Nutr. 2014 May;58(5):647-53. doi: 10.1097/MPG.0000000000000285.
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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.
Willem Broekaert, Ph.D. study director
Fugeia NV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheat Bran Extract in people with Gastrointestinal Health and Healthy Subjects, run by Fugeia NV 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 10 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 27 Oct 2009. 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.
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?
Bifidobacteria content in feces (time frame: day 19 or 20 of each intervention period). The study lists 3 primary outcomes in all. 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 NCT01001949, 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 27 Oct 2009.