Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population

NCT05529693 | Completed

• 1 other identifier: HND-IM-047
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effectiveness of two doses of the probiotic strain Bif-038 on markers of low-grade inflammation in a elderly population

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

• hs-CRP

  The effect of daily intake of Bif-038 10 billion CFU versus placebo on hs-CRP

  12 weeks

Secondary Outcomes (1)

• TNF-alfa

  12 weeks

Other Outcomes (14)

• Change in hsCRP

  6 and 12 weeks

• Change in TNF-alfa

  6 and 12 weeks

• Change in feces borne biomarker calprotectin

  12 weeks

Study Arms (3)

Bif-038 arm, high dose

EXPERIMENTAL

Active trial product with minimum 10 billion CFU daily dose

Dietary Supplement: Experimental: Bif-038 arm, high dose

Bif-038 arm, low dose

EXPERIMENTAL

Active trial product with minimum 1 billion CFU daily dose

Dietary Supplement: Experimental: Bif-038 arm, low dose

Placebo arm

PLACEBO COMPARATOR

Similar trial product, but without Bif-038 probiotic bacteria

Dietary Supplement: Placebo Comparator: Placebo arm

Interventions

Experimental: Bif-038 arm, high dose DIETARY_SUPPLEMENT

Active trial product with minimum 10 billion CFU daily dose

Also known as: Probiotic

Bif-038 arm, high dose

Experimental: Bif-038 arm, low dose DIETARY_SUPPLEMENT

Active trial product with minimum 1 billion CFU daily dose

Also known as: Probiotic

Bif-038 arm, low dose

Placebo Comparator: Placebo arm DIETARY_SUPPLEMENT

Similar product to trial product but without Bif-038

Also known as: Placebo

Placebo arm

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to participate in the study and comply with its procedures
• Able to give written informed consent
• Healthy adults as determined by the investigator
• Age: ≥ 60 years and ≤ 85 years
• hs-CRP: 2.0-10.0 mg/L
• BMI: 18.5-32 kg/m2
• Temperature between ≥35.5 and ≤37.3oC
• A stable body weight (≤5 % change) over the 3 months prior to screening.

You may not qualify if:

• Cold or flu-like (URTI) symptoms, with a Jackson Cold Scale score of \>2; not otherwise explained by seasonal allergies
• Chronic disease such as, cardiovascular diseases, gastrointestinal disorders, and rheumatoid arthritis, which in the Investigators judgment, precludes involvement in the study
• Oral antibiotics within 4 weeks prior to the screening visit
• Use of immunosuppressant drugs, systemic steroids or systemic antimicrobial medication (including suppositories) within the 4 weeks prior to the screening visit
• Regular oral non-steroidal anti-inflammatory medication use (1 week) (topical NSAIDS allowed). Low-dose prophylactic aspirin use is acceptable if stable for 9 months prior to screening.
• Uncontrolled, unstable hypertension at the discretion of the investigator.
• Current smoking, chewable tobacco and/or vaping. Low dose (\<50mg/week) nicotine products allowed.
• Planned change in current diet or exercise habits
• Habitual intake of probiotic supplements within 2 months before screening visit
• Have had gastrointestinal surgery (e.g. colectomy, cholecystectomy, gastric bypass); Appendectomy allowed. Laparoscopic surgeries (removal of polyps, cysts) are allowed.
• Have had any other condition or are taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk, or confound the interpretation of the study results;
• Any change in medication or supplement intake in the 30 days prior to baseline
• Any major dietary changes in the 30 days prior to baseline
• Has a history of drug and/or alcohol abuse at the time of enrolment;
• Has received treatment involving experimental drugs in 2 months prior to screening

Sponsors & Collaborators

• Chr Hansen: lead

Study Sites (1)

Atlantia Food Clinical Trials

Cork, T23 R50R, Ireland

Location

MeSH Terms

Conditions

Inflammation

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Timothy Dinan, Professor

  Atlantia Clinical Trials

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: September 7, 2022
• Study Start: September 29, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 1, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)