Effect of symbiotic administration on selected health indices in a human volunteer trial (dietary intervention)

ISRCTN	ISRCTN43435738
DOI	https://doi.org/10.1186/ISRCTN43435738
Protocol serial number	96/94
Sponsor	EU Commission (Belgium)
Funders	EU Commission, Estonian Science Foundation (Estonia)

Submission date: 16/06/2006
Registration date: 07/07/2006
Last edited: 25/09/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Marika Mikelsaar
Scientific

Ravila 19
Tartu
50411
Estonia

Phone	+372 (0)7 374 179
Email	marika.mikelsaar@ut.ee

Study information

Primary study design	Interventional
Study design	Randomised double-blind dietary (symbiotic) cross-over intervention study
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	The consumption of probiotic and prebiotic agents' influence on the human gastrointestinal ecosystem that may manifest the possible shifts in health indices in response to symbiotic intake.
Ethics approval(s)	Approved by the Ethics Review Committee on Human Research of the University of Tartu on 21/08/2001, reference number: 96/94
Health condition(s) or problem(s) studied	Healthy adults
Intervention	Symbiotic consumption versus placebo capsule. Volunteers were randomly allocated to receive either: 1. One sachet of prebiotic (6.6 g Raftilose®; P95) and two capsules of the freeze-dried probiotics (Lactobacillus fermentum ME-3, Lactobacillus paracasei 8700:2, Bifidobacterium longum 46; 3 x 10^9 colony forming units [CFU]) per day 2. Placebo (maltodextrin) twice a day for three weeks After a two-week washout period, volunteers were crossed over to another three weeks of symbiotic or placebo administration. Details of Joint Sponsor: Estonian Science Foundation Sihtasutus Eesti Teadusfond Endla 4, Tallinn Estonia http://www.etf.ee/
Intervention type	Other
Primary outcome measure(s)	The primary outcome measure is to assess the effect of symbiotic intake on health indices, biochemical markers, and faecal microflora
Key secondary outcome measure(s)	1. To assess the health indices of healthy adults (body mass index, blood pressure, bone mineral density) 2. The self-reported questionnaire was applied containing questions on welfare, nutritional habits, and habitual gastrointestinal symptoms (abdominal pain, flatulence, bloating, and stool frequency) 3. All subjects completed a modified semi-quantitative questionnaire about their nutritional habits 4. To determine haematological indices (haemoglobin, white blood cell count, red blood cells, platelets), plasma glucose, total cholesterol (TC), low-density lipoprotein-cholesterol (LDL), high-density lipoprotein-cholesterol (HDL), triglyceride and high-sensitive C-reactive protein (hsCRP) levels 5. To determine total antioxidative activity (TAA), total antioxidative status (TAS), oxidized low density lipoprotein (oxLDL), baseline diene conjugates of LDL (BDC-LDL) in blood samples 6. To determine in urine the content of 8-isoprostanes and biogenic amines 7. Faecal samples were analysed for presence of Helicobacter pylori antigen by the Helicobacter pylori stool antigen (HpSA) test (ImmunoCard STAT HpSA, Meridian Bioscience Europe, Italy) 9. Fluorescence in situ hybridisation (FISH) was used to monitor changes in faecal microflora after consumption of synbiotic
Completion date	30/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	53
Key inclusion criteria	1. Wish to participate in the study 2. Aged 20-60 years 3. Healthy (i.e. no known health problems and no medical conditions that require drug therapy) 4. Signed informed consent
Key exclusion criteria	1. History of any gastrointestinal disease 2. Use of any antimicrobial drug within last month 3. Use of any regular concomitant medication, including medical preparations 4. Pregnancy or breastfeeding 5. Food allergy
Date of first enrolment	17/02/2005
Date of final enrolment	30/06/2005

Locations

Countries of recruitment

Estonia

Study participating centre

Ravila 19

Tartu
50411
Estonia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan