Immune modulatory activity of a pre-probiotic blend in healthy adult volunteers
Conditions
Interventions
Duration of intervention: 8 weeks
Intervention group: A pre-probiotic blend and maltodextrose
Control group: maltodextrose
Sponsors
Nutricia Research BV
Eligibility
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| - 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. | — |
Contacts
Public ContactMonique Visser
Nutricia Research B.V.
Outcome results
None listed