To determine faecal microbiota composition and metabolite production (such as acetate, propionate and butyrate), and investigate differences between healthy controls and mild or severe patients IBS. Moreover, to investigate whether (clinical)…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint of this study is microbiota composition and metabolite
profiles, and the difference between groups and possible change after one
month. These are assessed two faecal samples, which are analysed by 16S rRNA
gene-based microbiota profiling.
Secondary outcome
Secondary parameters are dietary intake, Quality of Life, depression and
anxiety scores, and stool consistency and frequency, which are assessed by
validated questionnaires.
Background summary
Irritable Bowel Syndrome (IBS) is a gastro-intestinal disorder that strongly
affects Quality of Life and impairs daily functioning. However, the aetiology
and pathophysiology has been poorly understood. Studies suggest that intestinal
microbiota in IBS is altered, however a general consensus remains elusive. This
may be due to the large individual variation in microbiota and IBS symptoms,
and the cross-sectional designs. Moreover, other factors like diet, wellbeing
and metabolite profiles are often not taken into account. New evidence is
suggesting that IBS severity may be an important factor in microbiota
composition.
Study objective
To determine faecal microbiota composition and metabolite production (such as
acetate, propionate and butyrate), and investigate differences between healthy
controls and mild or severe patients IBS. Moreover, to investigate whether
(clinical) parameters such as symptom severity fluctuated, and if these
fluctuations are associated with an alteration in faecal microbiota composition
and metabolite production, one month after baseline, compared to healthy
controls.
Study design
This study is an observational longitudinal study, with two data collection
points (baseline and after one month).
Study burden and risks
This study has a relatively low burden and risk, since it is an observational
study. Participants only have to visit the study site once (at the information
event). All data collection will be done from home, and will be done twice,
which include faecal samples online questionnaire.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
Inclusion criteria
For IBS patients:
- Adults, aged 18-65 years.
- IBS patients that meet the Rome IV criteria.
- In close proximity of Wageningen (max. 50 km), for practical reasons: collection of the faecal samples.
- Have an Body Mass Index (BMI) between 18.5 and 30 kg/m2.
- Signed informed consent.
- After T1, IBS severity will be checked using the IBS-SSS. Subjects will be included for follow-up at T2, when they have the most mild symptoms (n<=30) or most severe (n<=30) symptoms. ;Healthy controls: will be age (±5 years), gender and BMI (±1kg/m2) matched with IBS patients. Other criteria:
- Adults, aged 18-65 years.
- No history of IBS, as assessed by the Rome IV criteria.
- Has a score <75 from the IBS-SSS.
- Are age (±5 years), gender and Body Mass Index (±1 kg/m2) matched with IBS patients.
- In close proximity of Wageningen (max. 50 km), for practical reasons: collection of the faecal samples.
- Signed informed consent.
Exclusion criteria
For IBS patients:
Presence of gastro-intestinal diseases, such as celiac disease, Crohn*s disease, or Ulcerative colitis.
- Have a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy.
- Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease.
- Female participants: currently pregnant or breast-feeding.
- Use of antibiotic treatment less than 3 months before start of the study and no use of antibiotics during the study.
- Are not participanting in another study during this study.
- Are an employee or student of the Division of Human Nutrition, Food and Biobased Research or Laboratory of Microbiologie, of Wageningen University & Research.
- Unwilling or unable to fulfil study criteria.
- If they are not selected in the most mild or most severe group at T1. ;For healthy controls:
- Presence of gastro-intestinal diseases, such as celiac disease, Crohn*s disease, or Ulcerative colitis.
- Have a history of intestinal surgery that might interfere with study outcomes. This does not include an appendectomy or cholecystectomy.
- Presence of significant systemic diseases, such as diabetes mellitus, cancer, cardiovascular disease or respiratory disease.
- Female subjects: currently pregnant or breast-feeding.
- Use of antibiotic treatment less than 3 months before start of the study.
- Are an employee of the Division of Human Nutrition, Food and Biobased Research or Laboratory of Microbiology, of Wageningen University & Research.
- Are subjects in another study during this study.
- Unwilling or unable to fulfil study criteria.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64950.081.18 |