Effect of AXOS on the Colon Metabolism in Healthy Volunteers | NCT01656499

Studies
Effect of AXOS on the Colon Metabolism in Healthy Volunteers

NCT01656499

Sponsor

KU Leuven

Status

Completed

Last Update Posted

Jan 14, 2015Estimated

Enrollment

20Actual

Phase

Phase 2

Conditions

Gut Health

Interventions

Arabinoxylanoligosaccharides
Maltodextrine

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Jul 2011Actual

Completion Date

Sep 2012Actual

First Submitted Date

Jul 30, 2012

First Submission Date that Met QC Criteria

Aug 1, 2012

First Posted Date

Aug 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2015

Last Update Posted Date

Jan 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arabinoxylanoligosaccharides (AXOS)	Active Comparator	AXOS (2 x 5g WBE/day)	Dietary Supplement: Arabinoxylanoligosaccharides
Maltodextrine (placebo)	Placebo Comparator	Maltodextrine (2 x 5g/day)	Dietary Supplement: Maltodextrine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Arabinoxylanoligosaccharides	Dietary Supplement		Arabinoxylanoligosaccharides (AXOS)
Maltodextrine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fecal water toxicity		Participants are followed for 10 weeks, with measurements on 4 specific time points

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy volunteers
regular dietary pattern (3 meals/day)
age: 18-45y
BMI: 18,5-27 kg/m2

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven/KU Leuven		Leuven	Vlaams-Brabant	3000	Belgium