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Effect of Galacto-Oligosaccharides supplementation on amoxicillin-treated gut microbiota from healthy adults : a proof of principal study

Effect of Galacto-Oligosaccharides supplementation on amoxicillin-treated gut microbiota from healthy adults : a proof of principal study - GOS-AMX Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39559
Enrollment
10
Registered
2013-04-24
Start date
2013-05-22
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

microbiota activity Microbiota composition

Interventions

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) and group 2 receives a drink with placebo (Maltodextrine 2,5 g 3x per day)

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 at age 0-3 months • Regular defecation (~1day) • Healthy as judge by the participant himself • Having signed the informed consent form

Exclusion criteria

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 by the volunteer him/herself or in his/her family (e.g. irritable bowel syndrome, inflammatory bowel disease) • Traveling to an Asian, African or south American country

Design outcomes

Primary

MeasureTime frame
The primary outcome is to compare the trends from the in-vivo study to the trends from the parallel in-vitro study regarding the microbiota composition and the microbiota activity. • Microbiota composition : amount of Bifidobacteria, Lactobacillus and Enterobacteriaceae in the faecal samples • Microbiota activity : amount of SCFA and remaining GOS in the faecal samples

Secondary

MeasureTime frame
The secondary outcome is to follow up the gastrointestinal symptoms (flatulence, consistency and frequency of faeces, incidence of diarrhoea) of faeces in the in-vivo study.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)