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ID
Source
Brief title
Health condition
Immune modulatory activity of a pre-probiotic blend in healthy adult volunteers
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
- 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.
Background summary
Not yet available
Study objective
H0: 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.
Study design
V1 ( Day 1); V2 (Day 14); V3 (Day 56)
Intervention
Duration of intervention: 8 weeks
Intervention group: A pre-probiotic blend and maltodextrose
Control group: maltodextrose
Monique Visser
PO Box 80141
Utrecht 3508 TC
The Netherlands
+31-30-2095000
monique.visser@nutricia.com
Monique Visser
PO Box 80141
Utrecht 3508 TC
The Netherlands
+31-30-2095000
monique.visser@nutricia.com
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
Design
Recruitment
IPD sharing statement
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 | NL6095 |
| NTR-old | NTR6242 |
| Other | Stichting BEBO : 15AL89652 |