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

Primary Purpose

Colonic Diseases [C06.405.469.158]

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
GOS addition
Placebo
Sponsored by
Wageningen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Diseases [C06.405.469.158] focused on measuring intestinal microbiota composition, intestinal microbiota activity, gastro-intestinal complains

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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*

Sites / Locations

  • Laboratory of Food Chemistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Placebo Comparator

Arm Label

GOS addition

placebo (maltodextrine)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 16, 2013
Last Updated
November 19, 2013
Sponsor
Wageningen University
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1. Study Identification

Unique Protocol Identification Number
NCT01848535
Brief Title
Effect of GOS Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults
Acronym
GOS
Official Title
Effect of Galacto-Oligosaccharides Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults : a Proof of Principal Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wageningen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases [C06.405.469.158]
Keywords
intestinal microbiota composition, intestinal microbiota activity, gastro-intestinal complains

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GOS addition
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
placebo (maltodextrine)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
GOS addition
Other Intervention Name(s)
Galacto-oligosaccharide, Vivinal GOS
Intervention Description
GOS (2.5g 3x per day) supplemented during 12 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
maltodextrine
Intervention Description
Maltodextrine(2.5g 3x per day) supplemented during 12 days
Primary Outcome Measure Information:
Title
Microbiota composition
Description
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.
Time Frame
evaluation between july and september 2013
Secondary Outcome Measure Information:
Title
Microbiota activity
Description
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.
Time Frame
evaluation between july and september 2013
Other Pre-specified Outcome Measures:
Title
Gastrointestinal complains
Time Frame
during the study (26 day) via a diary

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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*
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Ladirat, MSc
Organizational Affiliation
Wageningen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Food Chemistry
City
Wageningen
ZIP/Postal Code
6703HD
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19442165
Citation
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.
Results Reference
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Effect of GOS Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults

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