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

NCT ID: NCT01848535

Last Updated: 2013-11-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-07-31

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

Detailed Description

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Conditions

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Colonic Diseases [C06.405.469.158]

Keywords

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intestinal microbiota composition intestinal microbiota activity gastro-intestinal complains

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Group Type PLACEBO_COMPARATOR

GOS addition

Intervention Type DIETARY_SUPPLEMENT

GOS (2.5g 3x per day) supplemented during 12 days

Placebo

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type PLACEBO_COMPARATOR

GOS addition

Intervention Type DIETARY_SUPPLEMENT

GOS (2.5g 3x per day) supplemented during 12 days

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Maltodextrine(2.5g 3x per day) supplemented during 12 days

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Galacto-oligosaccharide Vivinal GOS maltodextrine

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\*
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Netherlands

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.

Reference Type BACKGROUND
PMID: 19442165 (View on PubMed)

Other Identifiers

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WUR42438

Identifier Type: OTHER

Identifier Source: secondary_id

ABRnr42438

Identifier Type: -

Identifier Source: org_study_id