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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT01848535
First received: April 16, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Colonic Diseases [C06.405.469.158]
Dietary Supplement: GOS addition
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Galacto-Oligosaccharides Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults : a Proof of Principal Study

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • Microbiota composition [ Time Frame: evaluation between july and september 2013 ] [ Designated as safety issue: No ]

    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 [ Time Frame: evaluation between july and september 2013 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Gastrointestinal complains [ Time Frame: during the study (26 day) via a diary ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: May 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: maltodextrine

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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*
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848535

Locations
Netherlands
Laboratory of Food Chemistry
Wageningen, Netherlands, 6703HD
Sponsors and Collaborators
Wageningen University
Investigators
Principal Investigator: Stephanie Ladirat, MSc Wageningen University
  More Information

Publications:
Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT01848535     History of Changes
Other Study ID Numbers: ABRnr42438, WUR42438
Study First Received: April 16, 2013
Last Updated: November 19, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Wageningen University:
intestinal microbiota composition
intestinal microbiota activity
gastro-intestinal complains

Additional relevant MeSH terms:
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014