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Probiotic on Psychological and Cognitive Effects

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Kent State University

Status

Completed

Conditions

Aging

Treatments

Other: Placebo
Dietary Supplement: Probiotic - Lactobacillus Rhamnosus GG

Study type

Interventional

Funder types

Other

Identifiers

NCT03080818
Kent State University

Details and patient eligibility

About

This study will determine whether supplementation of probiotic Lactobacillus Rhamnosus GG improves psychological status in middle age and older adults through a 12-week, randomized, double-blind, placebo-controlled clinical trial. Secondary analyses will be conducted to examine the possible benefits of probiotic supplementation on cognitive function and markers of physical health.

Enrollment

200 patients

Sex

All

Ages

55 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age 55-75 years
  • Able to speak and read English

Exclusion criteria

  • History of neurological, developmental, or severe psychiatric disorder (e.g. dementia, stroke, schizophrenia);
  • Antibiotic use in the past 30 days;
  • History of significant stomach or GI surgery (e.g. gastric bypass, cholecystectomy);
  • History of alcohol or illicit drug dependence;
  • History of severe heart, kidney, or liver problems (e.g. heart failure, liver failure);
  • Regular use of an acid-blocking medication in the past 30 days (i.e. proton pump inhibitor, H2 blocker);
  • Likely immunosuppression (e.g. chemotherapy treatment);
  • Regular use of other pre- or probiotic supplements in the past 30 days;
  • Severe gastrointestinal conditions including celiac disease, Crohn's disease, or diverticulitis.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

200 participants in 2 patient groups, including a placebo group

Probiotic
Experimental group
Description:
Participants in this arm will receive probiotic supplementation for 12 weeks (Lactobacillus Rhamnosus GG)
Treatment:
Dietary Supplement: Probiotic - Lactobacillus Rhamnosus GG
Control
Placebo Comparator group
Description:
Participants in this arm will receive placebo that look similar to probiotics
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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