Clinical trial NCT01848535: Effect of GOS Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults
Official title: Effect of Galacto-Oligosaccharides Supplementation on Amoxicillin-treated Gut Microbiota From Healthy Adults : a Proof of Principal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Diseases [C06.405.469.158]
Keywords: intestinal microbiota composition
intestinal microbiota activity
gastro-intestinal complains
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2013-05-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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\*

Primary outcomes:
measure: Microbiota composition
timeFrame: evaluation between july and september 2013
Secondary outcomes:
measure: Microbiota activity
timeFrame: evaluation between july and september 2013
Other outcomes:
measure: Gastrointestinal complains
timeFrame: during the study (26 day) via a diary
Locations:
city: Wageningen
country: Netherlands
facility: Laboratory of Food Chemistry
Study officials:
affiliation: Wageningen University
name: Stephanie Ladirat, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.