The objective of this study is to investigate the systemic immunoregulatory effect of synbitoics intervention after 8 weeks of daily study product intake
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
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
Food allergies affect up to 3% of the population of infants and young children
in western countries. For these children hypoallergenic infant formula is
available on the market. Hypoallergenic food decreases the chance of allergic
reactions. Nutricia Research is now developing a new version of this infant
formula containing synbiotics. These synbiotics may affect the composition of
bacteria in the intestines of children with allergies in such a way that it
more resembles that of children without allergies. This could decrease the
chance of having an allergic reaction. The effect of this new version of the
hypoallergic infant formula in infants and children with cow's milk allergy is
currently being investigated in 2 other studies. The goal of this study is to
learn more about the possible effects of synbiotics on the immune system.
Because this study is hard to execute in children for several reasons, it will
be executed in healthy adult volunteers.
Study objective
The objective of this study is to investigate the systemic immunoregulatory
effect of synbitoics intervention after 8 weeks of daily study product intake
Study design
This is a randomised, double-blind, parallel-group, placebo-controlled,
single-centre, 8 week multiple-dose study in 30 healthy adult volunteers.
Intervention
Test product: A pre-probiotic blend and maltodextrose
Control product: maltodextrose
Study burden and risks
Subjects will visit the research unit for a screening- and 3 study visits over
a period of 8 weeks. During the visits, blood and saliva will be collected and
subjects have to collect stool samples at home and hand in during the visits.
Subjects should take the study product daily for 8 weeks and should complete
questionnaires regularly. During participation, the subjects have to comply
with a number of rules related to the use of medication and supplements, sport,
food, alcohol and drugs.
There are no known risks of the study products, however the product may alter
the stool colour, consistency and frequency in the first days/ weeks of use,
and may cause stomach cramps, diarrhea and flatulence which may cause some
temporary pain or discomfort.
A light pain can be experienced in the arm during the placement of the needle
for blood sampling. Sometimes a blue spot appears afterwards at the place of
sampling.
Since the study will be performed with food ingredients, no serious adverse
events are expected. The amounts of pro- and pre-biotics in the study product
fall within the GRAS status (generally recognized as safe).
Uppsalalaan 12
Utrecht 3584 CT
NL
Uppsalalaan 12
Utrecht 3584 CT
NL
Listed location countries
Age
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
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 |
|---|---|
| CCMO | NL58758.056.16 |