Safety and tolerability of the synbiotic product in elderly persons

• Register: ISRCTN
• Last refreshed on: 21 February 2022
• Main ID: ISRCTN18123188
• Date of registration: 04/07/2017
• Prospective Registration: No
• Primary sponsor: BioCC OÜ
• Public title: Safety and tolerability of the synbiotic product in elderly persons
• Scientific title: Safety and tolerance testing of the synbiotic product of L. plantarum INDUCIA® and xylitol in elderly persons
• Date of first enrolment: 08/05/2017
• Target sample size: 70
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN18123188
• Study type: Interventional
• Study design: Randomised double-blind parallel dose intervention study (Quality of life)
• Phase: Not Applicable

Countries of recruitment

Estonia

Contacts

• Name: Merle Rätsep

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Relatively healthy elderly persons (over 64 years)
Digestive System
Relatively healthy elderly persons (over 64 years)

Intervention(s)

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.

Primary Outcome(s)

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(s)

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 a (TNFa)) are measured from fasting blood plasma using Randox Evidence Investigator at baseline and day 21

Secondary ID(s)

SYN-ELD2017

Source(s) of Monetary Support

Bio-Competence Centre of Healthy Dairy Products LLC Project EU48686

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 30/06/2018