ISRCTN - ISRCTN18123188: Safety and tolerability of the synbiotic product in elderly persons

Plain English Summary

Background and study aims
Clostridium difficile (Cd) infection (CDI) is one of the most common health-care associated infections in hospitals and nursing homes. Symptoms include watery diarrhea, fevers, nausea and abdominal pain. There are different ways to prevent CDI. It has been found that hospitalised patients with Cd have lower levels of certain kinds of bacteria in the intestines (bowels). Research has shown that using a combination of xylitol (a sugar sweetener) with a specific kind of probiotic (live bacteria and yeasts) caleld L. plantarum INDUCIA® prevents the cells of Cd to be able to provide toxins and grow in the gut. The aim of this study is to test the safety and tolerability of a product containing L. plantarum INDUCIA® and xylitol in relatively healthy elderly persons.

Who can participate?
Adults over the age of 64 who have a stable diet and physical activity level.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group eat one package of product daily for three weeks that contains a lower dose of L. plantarum INDUCIA® and xylitol. Those in the second group eat one package of product daily for three weeks that contains a higher dose of L. plantarum INDUCIA® and xylitol. Participants are followed up for one week after the treatment to have samples of blood and stool taken to see if they experienced any issues.

What are the possible benefits and risks of participating?
Participants may benefit from the providing more information about their health condition and from a consultation with a doctor. There are no notable risks with participating however participants may experience discomfort when providing blood samples.

Where is the study run from?
Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)

When is the study starting and how long is it expected to run for?
February 2016 to June 2018

Who is funding the study?
Bio-Competence Centre of Healthy Dairy Products LLC (Estonia)

Who is the main contact?
Merle Rätsep
merle.ratsep@tptak.ee

Trial website

Contact information

Type

Scientific

Primary contact

Miss Merle Rätsep

ORCID ID

Contact details

Bio-Competence Centre of Healthy Dairy Products
Riia 181A
Tartu
51014
Estonia
+372 534 66569
merlera@ut.ee

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SYN-ELD2017

Study information

Scientific title

Safety and tolerance testing of the synbiotic product of L. plantarum INDUCIA® and xylitol in elderly persons

Acronym

SYN-ELD

Study hypothesis

Synbiotic product of Lactobacillus plantarum INDUCIA® and prebiotic xylitol is well tolerated and causing no serious gastrointestinal complaints (adverse events) in relatively healthy elderly participants.

Ethics approval

Research Ethics Committee of the University of Tartu, 20/03/2017, ref: 268/T-13

Study design

Randomised double-blind parallel dose intervention study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Relatively healthy elderly persons (over 64 years)

Intervention

Participants are randomly allocated to one of two groups. Randomisation is prepared by study statistician using statistical analysis software SAS 9.2 and participants are randomly allocated to one of the treatment groups applying a 1:1 allocation ratio.

Group 1 (Lower dose): Participants take one package of product daily for three weeks. The package contains a daily dose of product containing 5x10e9 cfu of L. plantarum INDUCIA® and 15 grams of xylitol. The daily dose is packed in food-grade aluminium foil sachets. The content of a sachet containing the test product should be mixed with cool or ambient temperature water.

Group 2 (Higher dose): Participants take one package of product daily for three weeks. The package contains a daily dose of product containing 5x10e9 cfu of L. plantarum INDUCIA® and 20 grams of xylitol per package. The daily dose is packed in food-grade aluminium foil sachets. The content of a sachet containing the test product should be mixed with cool or ambient temperature water.

Participants take the product daily for three weeks and follow up is done one week after the end of the treatment. Participants receive a follow up phone call at the third day of the study. Participants are asked to provide stool samples between day 8 to 14 and ebtween day 28 to day 30. Participants are assessed for an adverse events and have stool and blood samples taken. Participants can call to study doctor if they have any questions or concerns regarding the study or their health condition during the study.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

Adverse events are measured using the patient diary (follow chart), self administered follow-up questionnaire filled once per week, patient interviews at baseline, day three and day 21.

Secondary outcome measures

1. Presence of L. plantarum INDUCIA is measured by molecular methods from stool samples collected at baseline, between day 8 to 14, day 21, and between day 28-30
2. Occurrence of Clostridium difficile is measured by RIDA®QUICK Clostridium difficile GDH test and molecular methods from stool samples collected at baseline and day 21
3. Lipidogram is measured using blood tests at baseline and day 21
4. Level of ox-LDL values are measured using blood tests (using ELISA) at baseline and day 21
5. Primary and secondary bile acids are measured from stool samples using High Pressure Liquid Chromatograph (HPLC) at baseline and day 21
6. Short chain fatty acids are measured from stool samples using High Pressure Liquid Chromatograph (HPLC) at baseline and day 21
7. Evidence METS I (ferritin, interleukin-6 (IL-6), insulin, leptin, Plasminogen Activator Inhibitor-1 (PAI-1), resistin, Tumour Necrosis Factor α (TNFα)) are measured from fasting blood plasma using Randox Evidence Investigator at baseline and day 21

Overall trial start date

01/02/2016

Overall trial end date

30/06/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Written informed consent
2. Aged over 64 years
3. Willingness to maintain a stable diet and physical activity level
4. Normal laboratory values with exception detailed in protocol
5. Normal, high normal and grade 1 systolic / diastolic blood pressure (≤159/99 mm Hg)
6. Normal, high normal and mild hypercholesterolemia

Participant type

Healthy volunteer

Age group

Senior

Gender

Both

Target number of participants

70

Participant exclusion criteria

1. Pregnancy and breastfeeding
2. (Food) allergy
3. Intolerance to the investigational product / its ingredients
4. Diabetes
5. Eating disorder
6. Active weight loss > 5 kg in prior 3 months
7. Extensive exercise (daily trainings of professional athletes)
8. Drug or alcohol abuse
9. Participation in other studies within the last 30 days / during the study
10. Any history of gastrointestinal diseases
11. Acute infection within the last 2 weeks prior to baseline
12. Use of any antimicrobial agents within the preceding 1 month
13. Donor within the last 1,5 months prior to start of the study (i.e. baseline visit)
14. Use of any pre-, probiotic or food supplement within the last 2 weeks prior to start of the study
15. Chronic inflammatory diseases

Recruitment start date

08/05/2017

Recruitment end date

08/05/2018

Locations

Countries of recruitment

Estonia

Trial participating centre

Bio-Competence Centre (BioCC)
Riia 181A
Tartu
51014
Estonia

Sponsor information

Organisation

Bio-Competence Centre of Healthy Dairy Products LLC

Sponsor details

Kreutzwaldi 1
Tartu
51014
Estonia

Sponsor type

Research organisation

Website

http://tptak.ee/en/

Funders

Funder type