SYNTREG
Completed
- Conditions
- Immune modulatory activity of a pre-probiotic blend in healthy adult volunteers
- Registration Number
- NL-OMON22553
- Lead Sponsor
- utricia Research BV
- Brief Summary
o
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Age ≥ 18 and ≤ 40 years
- Written informed consent
Exclusion Criteria
- Any medical condition that interferes with GI function (e.g irritable bowel syndrome, short bowel syndrome, inflammatory bowel disease, gastric ulcer, gastritis (gastro)enteritis)
- Constipation and/or diarrhoea within 1 week prior to Visit 1 (randomisation)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in IL-10 production and/or forkhead box protein 3 (Foxp3) expressing cells after 8 weeks of daily study product intake.
- Secondary Outcome Measures
Name Time Method - Change from baseline in IL-10 production and/or Foxp3 expressing cells after 2 weeks of daily study product intake <br /><br>- Change from baseline in the levels of several cytokines and prostaglandin E2 (PGE2) and fatty acid composition after 2 and 8 weeks of daily study product intake <br /><br>- Adverse events (AEs), gastrointestinal (GI) tolerance, stool frequency, consistency and colour.<br>