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

Completed

Conditions: microbiota activity
Microbiota composition
10017966

Registration Number: NL-OMON39559

Lead Sponsor: Wageningen Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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

• 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 < 6 months before the study
• Hypersensitivity or food allergy for products used in this study (e.g. Lactose, Penicillin)
• History of pre-existing allergies, such as asthma and hay fever
• 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*

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is to compare the trends from the in-vivo study to the<br /><br>trends from the parallel in-vitro study regarding the microbiota composition<br /><br>and the microbiota activity.<br /><br>• Microbiota composition : amount of Bifidobacteria, Lactobacillus and<br /><br>Enterobacteriaceae in the faecal samples<br /><br>• Microbiota activity : amount of SCFA and remaining GOS in the faecal samples </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome is to follow up the gastrointestinal symptoms<br /><br>(flatulence, consistency and frequency of faeces, incidence of diarrhoea) of<br /><br>faeces in the in-vivo study.</p><br>