Effect of GOS Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults
NCT ID: NCT01848535
Last Updated: 2013-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2013-05-31
2013-07-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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GOS addition
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.
GOS addition
GOS (2.5g 3x per day) supplemented during 12 days
Placebo
Maltodextrine(2.5g 3x per day) supplemented during 12 days
placebo (maltodextrine)
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.
GOS addition
GOS (2.5g 3x per day) supplemented during 12 days
Placebo
Maltodextrine(2.5g 3x per day) supplemented during 12 days
Interventions
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GOS addition
GOS (2.5g 3x per day) supplemented during 12 days
Placebo
Maltodextrine(2.5g 3x per day) supplemented during 12 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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\*
18 Years
40 Years
ALL
Yes
Sponsors
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Wageningen University
OTHER
Responsible Party
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Principal Investigators
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Stephanie Ladirat, MSc
Role: PRINCIPAL_INVESTIGATOR
Wageningen University
Locations
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Laboratory of Food Chemistry
Wageningen, , Netherlands
Countries
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References
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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. doi: 10.2174/138161209788168128.
Other Identifiers
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WUR42438
Identifier Type: OTHER
Identifier Source: secondary_id
ABRnr42438
Identifier Type: -
Identifier Source: org_study_id