Condition category
Nutritional, Metabolic, Endocrine
Date applied
16/06/2006
Date assigned
07/07/2006
Last edited
25/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Marika Mikelsaar

ORCID ID

Contact details

Ravila 19
Tartu
50411
Estonia
+372 (0)7 374 179
marika.mikelsaar@ut.ee

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

96/94

Study information

Scientific title

Acronym

Study hypothesis

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

Approved by the Ethics Review Committee on Human Research of the University of Tartu on 21/08/2001, reference number: 96/94

Study design

Randomised double-blind dietary (symbiotic) cross-over intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome measure is to assess the effect of symbiotic intake on health indices, biochemical markers, and faecal microflora

Secondary outcome measures

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

Overall trial start date

17/02/2005

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

53 adult volunteers (12 men and 41 women)

Participant 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

Recruitment start date

17/02/2005

Recruitment end date

30/06/2005

Locations

Countries of recruitment

Estonia

Trial participating centre

Ravila 19
Tartu
50411
Estonia

Sponsor information

Organisation

EU Commission (Belgium)

Sponsor details

European Commission Research Directorate-General
Commission Officer Isabelle de Froidmont-Görtz
Directorate E-Biotechnology
Agriculture and Food Research
Unit E2-Food Quality
B-1049
Brussels
SDME 8/31
Belgium
+32 (0)2 296 8571
isabelle.de-froidmont-goertz@cec.eu.int

Sponsor type

Government

Website

http://ec.europa.eu/research

Funders

Funder type

Government

Funder name

EU Commission

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Estonian Science Foundation (Estonia)

Alternative name(s)

Estonian Science Foundation, ETF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Estonia

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes