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

NCT01848535 | Completed DMC

• 2 other identifiers: ABRnr42438WUR42438
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Colonic Diseases [C06.405.469.158]

Keywords

intestinal microbiota composition; intestinal microbiota activity; gastro-intestinal complains

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Microbiota activity

  evaluation between july and september 2013

Other Outcomes (1)

• Gastrointestinal complains

  during the study (26 day) via a diary

Study Arms (2)

GOS addition

PLACEBO COMPARATOR

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; Dietary Supplement: Placebo

placebo (maltodextrine)

PLACEBO COMPARATOR

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; Dietary Supplement: Placebo

Interventions

GOS addition DIETARY_SUPPLEMENT

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

Also known as: Galacto-oligosaccharide, Vivinal GOS

GOS addition; placebo (maltodextrine)

Placebo DIETARY_SUPPLEMENT

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

Also known as: maltodextrine

GOS addition; placebo (maltodextrine)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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\*

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Laboratory of Food Chemistry

Wageningen, 6703HD, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 19442165 BACKGROUND

MeSH Terms

Interventions

4'-galactooligosaccharide

Study Officials

• Stephanie Ladirat, MSc

  Wageningen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: May 7, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 20, 2013

Record last verified: 2013-11

Locations

NL (1)