Pilot study on immune modulatory activity of a pre-probiotic blend in healthy adult volunteers

Completed

Conditions: food allergy
10001708

Registration Number: NL-OMON45397

Lead Sponsor: utricia Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Change from baseline in IL-10 production and/or forkhead box protein 3 (Foxp3)<br /><br>expressing cells after 8 weeks of daily study product intake.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Change from baseline in IL-10 production and/or Foxp3 expressing cells after<br /><br>2 weeks of daily study product intake<br /><br>- Change from baseline in the levels of several cytokines and prostaglandin E2<br /><br>(PGE2) and fatty acid composition after 2 and 8 weeks of daily study product<br /><br>intake<br /><br>- Adverse events (AEs), gastrointestinal (GI) tolerance, stool frequency,<br /><br>consistency and colour.</p><br>