search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


SYNTREG


- candidate number26703
- NTR NumberNTR6242
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-feb-2017
- Secondary IDs15AL89652 
- Public TitleSYNTREG
- Scientific TitlePilot study on immune modulatory activity of a pre-probiotic blend in healthy adult volunteers
- ACRONYMSYNTREG
- hypothesisH0: The effect of product A is equal to the effect of product B with respect to change from baseline after 8 weeks of study product intake in IL-10 production [pg/mL] AND in Foxp3 expressing cells.
H1: The effect of product A is unequal to the effect of product B with respect to change from baseline after 8 weeks of study product intake in IL-10 production [pg/mL] OR in Foxp3 expressing cells.
- Healt Condition(s) or Problem(s) studiedImmune status, Probiotics
- Inclusion criteria- Age ≥ 18 and ≤ 40 years
- Written informed consent
- Willingness and ability to comply with the study protocol
- Body Mass Index (BMI) ≥ 18.5 and ≤ 24.9 kg/m2
- Non-smoking or stopped smoking for at least 3 months prior to Visit 1 (randomisation)
- Regular stool (stool frequency of at least 1 stool in 3 days)
- Judged by the investigator to be in good health
- 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)
- Any known allergy and/or intolerance (e.g. coeliac disease, gluten intolerance, allergy to one of the ingredients of the study product)
- Any known renal or hepatic failure
- (History of) any immunological disease and/ or immunodeficiency
- (History of) any cancer with the exception of basal cell carcinoma
- Use of prokinetics, laxatives, antidiarrhoeals, corticosteroids, proton-pump inhibitors (or other gastric acid reducers), immunosuppressants or any active allergy treatment within 3 weeks of Visit 1 (randomisation)
- (History of) any chemotherapy or immunotherapy
- Use of antibiotics within 3 months of screening
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 21-feb-2017
- planned closingdate26-mei-2017
- Target number of participants30
- InterventionsDuration of intervention: 8 weeks
Intervention group: A pre-probiotic blend and maltodextrose
Control group: maltodextrose
- Primary outcomeChange 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- Change from baseline in IL-10 production and/or Foxp3 expressing cells after 2 weeks of daily study product intake
- 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
- Adverse events (AEs), gastrointestinal (GI) tolerance, stool frequency, consistency and colour.
- TimepointsV1 ( Day 1); V2 (Day 14); V3 (Day 56)
- Trial web siten/a
- statusplanned
- CONTACT FOR PUBLIC QUERIES Monique Visser
- CONTACT for SCIENTIFIC QUERIES Lucien Harthoorn
- Sponsor/Initiator Nutricia Research BV
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research
- PublicationsNot yet available
- Brief summaryNot yet available
- Main changes (audit trail)
- RECORD14-feb-2017 - 29-apr-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl