Clinical trial NCT01001949: In Vivo Evaluation of the Physiological Effects of Arabinoxylan-oligosaccharides (AXOS) in Healthy Subjects (Juniors)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Health
Healthy Subjects
Lead sponsor: Fugeia NV
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 29
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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).

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).


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Bifidobacteria content in feces
timeFrame: day 19 or 20 of each intervention period
measure: butyric acid content in feces
timeFrame: day 19 or 20 of each intervention period
measure: stool frequency
timeFrame: third week of each intervention period
Secondary outcomes:
measure: adverse events
timeFrame: whole study period
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Gastrointestinal Research, Laboratory Digestion and Absorption
Study officials:
affiliation: Fugeia NV
name: Willem Broekaert, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.