Skip to main content
OpenTrials
Completed

NCT Number: NCT01848535

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colonic Diseases [C06.405.469.158]

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratory of Food Chemistry

Wageningen, 6703HD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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*

Treatment and study plan

GOS addition

Dietary Supplement

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

Other names: Galacto-oligosaccharide, Vivinal GOS

Placebo

Dietary Supplement

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

Other names: maltodextrine

Primary outcomes

  1. Microbiota composition

    Time frame: evaluation between july and september 2013

    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 outcomes

  1. Microbiota activity

    Time frame: evaluation between july and september 2013

    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.

Other outcomes

  1. Gastrointestinal complains

    Time frame: during the study (26 day) via a diary

Sponsors and collaborators

Lead sponsor

Wageningen University

Other

Registry information

Official study title

Effect of Galacto-Oligosaccharides Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults : a Proof of Principal Study

Acronym: GOS

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 7, 2013
Registry last updated
Nov 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.