Colonic Diseases [C06.405.469.158]
Conditions
Keywords
intestinal microbiota composition, intestinal microbiota activity, gastro-intestinal complains
Brief summary
Prebiotics are thought to be a potential means to prevent antibiotic-associated diarrhoea because of their ability to stimulate beneficial bacteria. In-vitro results showed a promising recovery of Bifidobacteria combined with an increase of Short Chain Fatty Acids (SCFA) upon Galacto-oligosaccharides (GOS) supplementation to amoxicillin-treated microbiota. As the microbiota is nowadays considered as a key factor in human health, a further understanding of the gut microbiota functioning in-vivo is essential. This understanding of the use of specific prebiotics may possibly be beneficial in the prevention or recovery of antibiotic-disturbed microbiota. As the effects of GOS supplementation on the microbiota composition and activity from healthy adults receiving amoxicillin have never been tested in-vivo, the investigators propose the current study as a proof of principle. Objective: To explore whether the promising effects of GOS supplementation on the composition and activity of gut microbiota from healthy adults as found by in-vitro, can also be observed in-vivo. Study population: 10 healthy men and women volunteers, 18 - 40 yr old
Interventions
DIETARY_SUPPLEMENTGOS addition
GOS (2.5g 3x per day) supplemented during 12 days
DIETARY_SUPPLEMENTPlacebo
Maltodextrine(2.5g 3x per day) supplemented during 12 days
Sponsors
Wageningen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: 18-40 \* * BMI: 18.5-25 kg/m2 * Stable weight over the last 6 months * Western diet * Availability of information about birth by caesarean section and breast-feeding * Regular defecation (\ 1day) * Healthy as judge by the participant himself * Having signed the informed consent form
Exclusion criteria
* Smoking or drug use * Pregnant (include planning to be or gave birth in the last 6 months) or lactating woman * Using contraceptive pill * Gastro-intestinal diseases (e.g. irritable bowel syndrome, inflammatory bowel disease) * Traveling to an Asian, African or south American country \< 6 months before the study * Hypersensitivity or food allergy for products used in this study (e.g. Lactose, Penicillin) * Having hepatic disease and renal failure * Using medication other than paracetamol, acetylsalicylic acid (aspirin), hay fever, asthma * Not willing to have the family doctor be informed about participation to the study. * Antibiotic use \< 3 months before the study * More than 3 antibiotic treatments in the last 2 years. * Probiotic or prebiotic use \< 1 month before the study\*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiota composition | evaluation between july and september 2013 | Microbiota composition of the collected faecal sample will be investigated using a phylogenetic microarray, the Intestinal-Chip. With this microarray, more than 400 species of the intestinal microbiota can be detected. Bifidobacteria and Lactobacillus as beneficial bacteria as well as Enterobacteriaceae and possible other pathogens (Cells/ g faecal dry weight) will also be measured using a real-time PCR with specific primers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiota activity | evaluation between july and september 2013 | The Short Chain Fatty acid (SCFA) amount produced will be measured using chromatographic approaches (Gas Chromatography, High Performance Liquid Chromatography). The remaining GOS will be measured with High Performance Anion Exchange Chromatography (HPAEC) or with Capillary Electrophoresis -Light Induced Fluorescence, which has a better resolution than HPAEC. |
Other
| Measure | Time frame |
|---|---|
| Gastrointestinal complains | during the study (26 day) via a diary |
Countries
Netherlands
Outcome results
None listed