Colonic Diseases [C06.405.469.158] Clinical Trial
— GOSOfficial title:
Effect of Galacto-Oligosaccharides Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults : a Proof of Principal Study
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
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 40 Years |
| Eligibility |
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* |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Laboratory of Food Chemistry | Wageningen |
| Lead Sponsor | Collaborator |
|---|---|
| Wageningen University |
Netherlands,
Saulnier DM, Kolida S, Gibson GR. Microbiology of the human intestinal tract and approaches for its dietary modulation. Curr Pharm Des. 2009;15(13):1403-14. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Gastrointestinal complains | during the study (26 day) via a diary | Yes | |
| Primary | Microbiota composition | 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. |
evaluation between july and september 2013 | No |
| Secondary | Microbiota activity | 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. |
evaluation between july and september 2013 | No |