Effect of GOS Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults

Study Overview
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Brief Summary
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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

Official Title
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Effect of Galacto-Oligosaccharides Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults : a Proof of Principal Study

Conditions
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Colonic Diseases [C06.405.469.158]

Intervention / Treatment
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* Dietary Supplement: GOS addition
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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*

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: GOS addition<br>All subjects will receive amoxicillin (375 mg 3x per day) for 5 days. Group 1 receives a drink with GOS (2,5 g 3x per day) simultaneously to the antibiotic for 5 days and after the antibiotic treatment for another 7 days. The intervention products should be consumed at breakfast/lunch/dinner. | Dietary Supplement: GOS addition<br>* GOS (2.5g 3x per day) supplemented during 12 days<br>* Other names: Vivinal GOS;Dietary Supplement: Placebo<br>* Maltodextrine(2.5g 3x per day) supplemented during 12 days<br>* Other names: maltodextrine;|
| Placebo Comparator: placebo (maltodextrine)<br>All subjects will receive amoxicillin (375 mg 3x per day) for 5 days. Group 2 receives a drink with placebo, maltodextrin(2,5 g 3x per day) simultaneously to the antibiotic for 5 days and after the antibiotic treatment for another 7 days. The intervention products should be consumed at breakfast/lunch/dinner. | Dietary Supplement: GOS addition<br>* GOS (2.5g 3x per day) supplemented during 12 days<br>* Other names: Vivinal GOS;Dietary Supplement: Placebo<br>* Maltodextrine(2.5g 3x per day) supplemented during 12 days<br>* Other names: maltodextrine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intestinal microbiota composition, intestinal microbiota activity, gastro-intestinal complains