Probiotic Effects on the Microbe-brain-gut Interaction and Brain Activity During Stress Tasks in Healthy Subjects

NCT03615651 | Completed

• 1 other identifier: 2017/398
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine if and how the "Probiotic Product" affects functional brain responses in healthy subjects during an emotional- and arithmetic stress task, respectively and in terms of microbe-brain-gut interactions.

Conditions

Probiotics; Gut Microbiota; Emotional Stress; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• Change in brain response to validated emotional challenge task (EAT) during functional brain imaging

  Comparing week 4 and 12

Secondary Outcomes (1)

• Change in brain response to a cognitive challenge task (MIST) during functional brain imaging

  Comparing week 4 and 12

Other Outcomes (15)

• Change in physical activity assessed by an actigraphy watch (actiwatch)

  Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods)

• Change in sleep quality assessed by an actigraphy watch (actiwatch)

  Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods)

• Change in daily stress levels assessed by an actigraphy watch (actiwatch)

  Comparing the change in week 0 compared to 4, and 8 compared to 12 (before and in the end of the two intervention periods)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

All study participants will receive the study product and the placebo in a randomized, double-blind crossover fashion. Probiotic and placebo products have similar appearance and taste.

Other: Placebo

Probiotic

EXPERIMENTAL

All study participants will receive the study product and the placebo in a randomized, double-blind crossover fashion. Probiotic and placebo products have similar appearance and taste.

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

The Probiotic Formula is commercially available and contains a combination of 3 probiotic strains in addition to other nutrients. The total daily amount of probiotic strain in the product will be no less than 3 billion colony-forming units (CFU) per 3 g powder sachet.

Probiotic

Placebo OTHER

Placebo intervention.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Age: 18-65 years, males/females.
• Signed informed consent -

You may not qualify if:

• Concurrent or recent treatment with drugs affecting intestinal function or mood, e.g., antidepressants (\< 12 weeks) or antibiotics (\< 12 weeks).
• Concurrent or recent (\< 4 weeks) use of nutritional supplements or herb products affecting intestinal function or mood (e.g. aloe vera, St. John´s Wort, fibers, prebiotics and probiotics).
• Diagnosis of major psychiatric or somatic disease. 4) Abuse of alcohol or drugs. 5) Recent (\< 4 weeks) intake of proton pump inhibitors, proton pump inhibitors, PPIs (e.g., omeprazole).
• \) Asthma. 7) Cardiovascular diseases. 8) Epilepsy. 9) Renal failure. 10) Cerebral bleeding or history of cerebral bleeding. 11) Allergic to latex. 12) Pregnancy (assessed by urine test) or breastfeeding. 13) Claustrophobia. 14) Smoking or using tobacco including snuff. 15) Inability to maintain exercise routine and dietary pattern during the study.
• \) Consumption of more than 6 cups of coffee/caffeine-containing beverages per day.
• \) Professional athlete. 18) Dominant left-hand. 19) Medical implant (e.g., pacemaker). 20) Aneurysm clips in the head. 21) Shunts in the head. 22) Grenade-splinter or metal-splinter in the body (e.g., eyes). 23) Metal or electrodes in the body (e.g., temp-catheter, aorta stent, cochlea implant).
• \) Comprehensive tooth-implants or prothesis. 25) Operated in the head. 26) Operated in the heart. 27) Swallowed a video-capsule. 28) Non-corrected astigmatism. 29) Regular intake of systemic corticosteroids and anti-inflammatory medication (including NSAIDs) during the last three months.
• \) Visual defect without possibility to use lenses during MRI scanning. 31) Known allergy to milk or soy. 32) Any other reason the investigator feels the subject is not suitable for participation in the study.

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Pfizer: collaborator

Study Sites (1)

Örebro University, Campus USÖ, Örebro University Hospital

Örebro, 70182, Sweden

Location

Related Publications (1)

• Rode J, Edebol Carlman HMT, Konig J, Repsilber D, Hutchinson AN, Thunberg P, Andersson P, Persson J, Kiselev A, Lathrop Stern L, Salomon B, Mohammed AA, Labus JS, Brummer RJ. Probiotic Mixture Containing Lactobacillus helveticus, Bifidobacterium longum and Lactiplantibacillus plantarum Affects Brain Responses Toward an Emotional Task in Healthy Subjects: A Randomized Clinical Trial. Front Nutr. 2022 Apr 29;9:827182. doi: 10.3389/fnut.2022.827182. eCollection 2022.

  PMID: 35571902 DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Robert Brummer, Prof

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: August 6, 2018
• Study Start: January 22, 2018
• Primary Completion: June 16, 2018
• Study Completion: June 16, 2018
• Last Updated: August 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)