Safety and tolerability of the synbiotic product in elderly persons

Not Applicable

Completed

• Conditions: Relatively healthy elderly persons (over 64 years); Digestive System

• Registration Number: ISRCTN18123188
• Lead Sponsor: BioCC OÜ

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-04
• Study Completion: 2018-06-30
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.