Published:
Last updated:
NA
ID
NL-OMON21010
Source
NTR
Brief title
PAMDC
Condition
- Inborn errors of metabolism
Health condition
Research involving
Human
Sponsors and support
Primary sponsor
:
Danone Nutricia Research
Source(s) of monetary or material Support
:
Material support provided by Nutricia Research
Intervention
- Other intervention
Explanation
Outcome measures
Primary outcome
Phylogenetic composition of the gut microbiota in PA patients
Secondary outcome
NA
Background summary
NA
Study objective
NA
Study design
Routine hospital visit (T0), First stool collection (week1), Second stool collection (week 5), third stool collection (week 9), fourth stool collection (week 13)
Intervention
NA
Public
Scientific
Age
Children (2-11 years)
Adolescents (12-15 years)
Adolescents (16-17 years)
Adults (18-64 years)
Inclusion criteria
Having PA (or having a sibling with PA) and age >4 yr and preferably <10 yr (upper age limit is 18 yr).
Exclusion criteria
PA patients with confounding intestinal diseases (e.g. colon rectal cancers, Crohn's disease, Ulcerative colitis).
Design
Study phase
:
N/A
Study type
:
Observational non invasive
Intervention model
:
Other
Allocation
:
Non controlled trial
Masking
:
Open (masking not used)
Control
:
Active
Recruitment
NL
Recruitment status
:
Recruitment stopped
Start date (anticipated)
:
Enrollment
:
40
Type
:
Actual
IPD sharing statement
Plan to share IPD
:
No
Positive opinion
Date
:
Application type
:
First submission
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 |
|---|---|
| NTR-new | NL6130 |
| NTR-old | NTR6269 |
| Other | : IRAS project ID: 199265 |
Summary results
NA