Pilot Study to Assess the Effect of a Probiotic Blend on Moderate Self-reported Anxiety.

NCT05562752 | Completed

• 2 other identifiers: CTB2022TN105P1AFCRO-154
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy of a multistrain probiotic administered in the form of a capsule in the management of moderate self-reported anxiety in adults aged 18-65

Conditions

Anxiety

Keywords

probiotic; microbiome; postbiotic

Outcome Measures

Primary Outcomes (1)

• Change in Anxiety rating

  Level of anxiety measured with "Hamilton Anxiety Rating Scale". (max 56 points) where a lower score means better outcomes compared to baseline.

  Day 0, Day 42, Day 84.

Secondary Outcomes (8)

• Change in Depression score

  Day -7, Day 0, Day 28, Day 42, Day 84.

• Change in Depression score

  Day 0, Day 28, Day 42, Day 84.

• Change in trait anxiety

  Day 0, Day 28, Day 42, Day 84.

• Change in perceived stress

  Day 0, Day 28, Day 42, Day 84.

• Change in Stress

  Day 0, Day 42, Day 84.

Other Outcomes (1)

• Change in GI microbiome

  Day 0, Day 84.

Study Arms (2)

Active

EXPERIMENTAL

Arm receiving investigational product (probiotic)

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Arm receiving placebo

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

multistrain probiotic in the form of a capsule with a daily dose of 1E+9 Colony Forming Unit (CFU) per day for 12 weeks.

Active

Placebo DIETARY_SUPPLEMENT

Matching placebo in a form of a capsule for 12 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to give written informed consent.
• Be between 18 to 65 years inclusive.
• Mild to moderate self-reported anxiety, defined as a Beck Anxiety Inventory (BAI) score ≥8 and ≤25.
• Have a Beck Depression Inventory (BDI) score \<25.
• Is in general good health, as determined by the investigator.
• Be willing to maintain stable dietary habits and physical activity levels throughout the study period.
• Be able to communicate well with the Investigator, to understand and comply with the requirements of the study and be judged suitable for the study in the opinion of the Investigator.
• Willing to consume the study product daily for the duration of the trial and comply with all trial procedures.
• Be able to give confirmation of ongoing informed consent
• Has been allocated to the placebo arm of Part I of the trial
• Has been deemed a "non-responder"

You may not qualify if:

• Are less than 18 or greater than 65.
• Participants who are pregnant or wish to become pregnant during the trial.
• Participants who are lactating and/or currently breastfeeding
• Participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:
• Complete abstinence from intercourse two weeks prior to administration of the study product, throughout the clinical trial, until the completion of follow-up procedures or for two weeks following discontinuation of the study product in cases where Participant discontinues the trial prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
• Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
• Sexual partner(s) is/are exclusively female.
• Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g. male condom, female diaphragm), tubal ligation or contraceptive pill. The Participant must be using this method for at least 1 week prior to and 1 week following the end of the trial.
• Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least 2 weeks prior to the first Screening Visit, throughout the trial, and 2 weeks following the end of the trial.
• Are hypersensitive to any of the components of the study product.
• Has taken systemic antibiotics within the previous 8 weeks.
• Has taken probiotics or post-biotics within the previous 8 weeks.
• Has a current clinical diagnosis of depression - determined in their medical history.
• Has self-reported or suspected consumption of excess quantities of alcohol or recreational drugs
• Diagnosed with significant physical comorbidity that, in the investigator's judgment, precludes involvement in the study.

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food Clinical Trials

Cork, Ireland

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study consists of 2 parts with the participants in part 2 being recruited from "Placebo non-responders" in Part 1.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 3, 2022
• Study Start: December 20, 2022
• Primary Completion: August 15, 2023
• Study Completion: August 15, 2023
• Last Updated: January 22, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)