A study to investigate the effect of host and food factors on carbohydrate fermentation by healthy adult human gut bacteria

Not Applicable

Completed

• Conditions: Healthy adults- gut microbiome composition; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12619001721190
• Lead Sponsor: Riddet Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-06
• Study Completion: 2020-10-30
• Last Update Posted: 20 September 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Medically healthy (according to exclusion criteria listed below)
BMI between 18.5 and 30
Long term consumption of a moderate-high fibre diet (at least 15 g/day)
Happy to provide a 3-day food and hydration diary
Happy to complete a general health screening questionnaire

Exclusion Criteria

According to a health screening questionnaire:
Some current health concerns
Previously diagnosed with norovirus, hepatitis A or intestinal parasite (ever)
Currently experiencing any flu-like symptoms (fever, headache, dehydration, weight loss, lethargy)
Noticed blood in faeces over the last 3 months
Previously diagnosed with Salmonella, Shigella, Yersinia, Campylobacter, Aeromonas, Candida, E.coli, Klebsiella, Cryptosporidium, Entamoeba histolytics (ever)
Somebody in the household has had diarrhoea, vomiting, stomach pain or upset stomach in the last 3 months
Experienced gastrointestinal symptoms over the last 3 months (loss of appetite, nausea, vomiting, diarrhoea)
Taken medicines over the last 2 weeks excluding contraception
Used antibiotics or laxatives in the last 3 months
According to the Bristol Stool Chart, most common type of stool is rated 1 or 7
In a typical day, defecate less than 1 time per day

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Breath methane concentration as assessed by a breath sample and laboratory analysis[Single collection after participant recruitment];Faecal microbial communities identified by shotgun metagenomic sequencing of faecal sample[Single timepoint, collection of faecal sample after participant recruitment ]

Secondary Outcome Measures

Name	Time	Method
Participant health status as assessed by a health screening questionnaire. Questionnaire was designed specifically for this study, using NZ Blood Donor Session Record (2017) and the Cornell University Biological Agent Reference Sheet for Human Feces and Urine (2017) as a basis for the questions. [One online health screening questionnaire during participant recruitment ]