Probiotics Against Low Grade Inflammation and Increased Intestinal Permeability in the Elderly

Probi AB

Status: Completed

Conditions: Increased Intestinal Permeability; Low-grade Inflammation

Treatments: Dietary Supplement: Active, only probiotics; Dietary Supplement: Placebo; Dietary Supplement: Active, blend of berries and probiotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02342496

2014/3

Details and patient eligibility

About

The purpose of this study is to evaluate the ability of a blend of berries and probiotics in reducing low-grade inflammation and intestinal permeability in the elderly. The intervention period is one month. Blood and fecal samples will be collected for analysis at baseline and at the end of the intervention with the aim to analyse possible changes in different parameters at the two timepoints. The participants will also be asked to keep a study diary throughout the study period for the documentation of their intestinal health and as a means for checking compliance.

Enrollment: 66 patients

Sex: All

Ages: 75 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age >75 years
• CRP 2-10 mg/L
• Ability to fill in a study diary by him/herself

Exclusion criteria

• Intake of antibiotic treatment in the last 4 weeks before inclusion into the study.
• Currently on corticosteroid treatment
• Presence of chronic inflammatory disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

66 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Powder consisting of maltodextrine, treated to resemble the Active product in appearance and taste.

Treatment:

Dietary Supplement: Placebo

Active, only probiotics

Active Comparator group

Description:

Powder consisting of freezedried bacteria at 10 billions cfu/daily dose and maltodextrine, treated to resemble the Active product in appearance and taste.

Treatment:

Dietary Supplement: Active, only probiotics

Active, blend of berries and probiotics

Active Comparator group

Description:

Powder consisting of freezedried berries , probiotics at 10 billions cfu/daily dose and maltodextrine.

Treatment:

Dietary Supplement: Active, blend of berries and probiotics