Effect of probiotic supplement (L. plantarum strain TENSIA) on healthy volunteers

Effect of a food supplement containing the probiotic strain of Lactobacillus plantarum TENSIA DSM 21380 on blood indices and intestinal microflora of healthy volunteers: a randomized placebo-controlled parallel trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN24502121

Enrollment

Registered

2011-08-24

Start date

2011-09-26

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving intestinal flora Digestive System

Interventions

Participants randomised to active or placebo group will be required during 3 weeks: 1. Active intervention: probiotic supplement containing Lactobacillus plantarum strain TENSIA (dail

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Wish to participate in the study 2. Aged 18 years and over 3. Healthy (i.e., no known health problems and no medical conditions that require drug therapy) 4. Signed informed consent

Exclusion criteria

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. Food allergy 5. Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
1. Adverse gastrointestinal effects 2. Negative shifts in values of systemic inflammation markers 3. Changes in lipid metabolism 4. Changes in key immunological parameters and markers of oxidative stress 5. Reduction of blood pressure Measured pre intervention, at the end of the intervention and also 1 week post intervention	—

Secondary

Measure	Time frame
1. Changes in fecal microflora 2. Persistence of ingested probiotic strain for 1 week	—

Countries

Estonia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026