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

Wageningen University

Status: Completed

Conditions: Colonic Diseases [C06.405.469.158]

Treatments: Dietary Supplement: GOS addition; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01848535

WUR42438 (Other Identifier)

ABRnr42438

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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*

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

GOS addition

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: GOS addition

placebo (maltodextrine)

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: GOS addition