NL-OMON45397CompletedNot Applicable
Pilot study on immune modulatory activity of a pre-probiotic blend in healthy adult volunteers - SYNTREG
utricia Research0 sites30 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
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
Investigators
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