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

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

Study Overview

• Status: Completed
• Conditions: Colonic Diseases [C06.405.469.158]
• Intervention / Treatment: Dietary supplement: GOS addition; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Wageningen, Netherlands, 6703HD
    • Laboratory of Food Chemistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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*

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	Dietary supplement: GOS addition; GOS (2.5g 3x per day) supplemented during 12 days; Other Names: Galacto-oligosaccharide; Vivinal GOS; Dietary supplement: Placebo; Maltodextrine(2.5g 3x per day) supplemented during 12 days; Other Names: maltodextrine
Placebo Comparator: 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.	Dietary supplement: GOS addition; GOS (2.5g 3x per day) supplemented during 12 days; Other Names: Galacto-oligosaccharide; Vivinal GOS; Dietary supplement: Placebo; Maltodextrine(2.5g 3x per day) supplemented during 12 days; Other Names: maltodextrine

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Gastrointestinal complains	during the study (26 day) via a diary

Collaborators and Investigators

• Sponsor: Wageningen University
• Investigators: Principal Investigator: Stephanie Ladirat, MSc, Wageningen University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: April 16, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Estimate): November 20, 2013
• Last Update Submitted That Met QC Criteria: November 19, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: intestinal microbiota composition; intestinal microbiota activity; gastro-intestinal complains
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Colonic Diseases
• Other Study ID Numbers: ABRnr42438; WUR42438 (Other Identifier: wageningen university)