Determination of the Safety and Efficacy of Two Probiotic Strains

NCT06466174 | Not Yet Recruiting

• 1 other identifier: PCTB202108
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to determine the safety and efficacy of two probiotic strains in adults with mild to moderate gastrointestinal discomfort. The main questions it aims to answer is whether 6-week administration of a probiotic can improve how the participant feels regarding their gut health. This is done by completing a weekly questionnaire and the results are compared between the 6 weeks the participants are on a placebo and the 6 weeks the participants are on the probiotic. Participants will also provide a blood sample, and stool sample at the start and end of each treatment. Similarly, the results from the blood samples and stool samples will be analysed to determine if there is any improvement in markers related to gut health.

Conditions

Gastrointestinal Dysfunction

Keywords

probiotic; gastrointestinal discomfort

Outcome Measures

Primary Outcomes (1)

• Change in GSRS-IBS score

  Change in the GSRS-IBS score while participants are on the treatment as compared with placebo. GSRS-IBS ranges from 0-78 with a greater score indicating a higher occurence of gastrointestinal symptoms

  Baseline vs Week 6

Secondary Outcomes (4)

• Incidence of upper respiratory tract symptoms

  Baseline vs Week 6

• Duration of upper respiratory tract symptoms

  Baseline vs Week 6

• Incidence of urinary tract infections

  Baseline vs Week 6

• Duration of urinary tract infections

  Baseline vs Week 6

Other Outcomes (7)

• Change in Stool consistency

  Baseline vs Week 6

• Questionnaire regarding general health

  Baseline vs Week 6

• Changes in microbiome readouts

  Baseline vs Week 6

Study Arms (4)

Placebo 1 to Probiotic A

ACTIVE COMPARATOR

Sequence A1 (n=25): Placebo 1 administered daily for 42 days, followed by 21 days washout, then 1 x 10\^9 colony forming units (CFU) of Probiotic A administered daily for 42 days

Dietary Supplement: Placebo 1 to Probiotic A

Placebo 2 to Probiotic B

ACTIVE COMPARATOR

Sequence B1 (n=25): Placebo 2 administered daily for 42 days, followed by 21 days washout and 42 days Probiotic formula: containing 1 x 10\^9 CFU of Probiotic B administered daily

Dietary Supplement: Placebo 2 to Probiotic B

Probiotic A to Placebo 1

ACTIVE COMPARATOR

Sequence A2 (n=25): 1 x 10\^9 CFU of Probiotic A administered daily for 42 days, followed by 21 days washout, then Placebo 1 administered daily for 42 days

Dietary Supplement: Probiotic A to Placebo 1

Probiotic B to Placebo 2

ACTIVE COMPARATOR

Sequence B2 (n=25): 1 x 10\^9 CFU of Probiotic B administered daily for 42 days, followed by 21 days washout and 42 days Placebo 2 administered daily for 42 days

Dietary Supplement: Probiotic B to Placebo 2

Interventions

Placebo 1 to Probiotic A DIETARY_SUPPLEMENT

42 day Crossover study design between Placebo 1 and Probiotic A (n = 25)

Placebo 1 to Probiotic A

Probiotic A to Placebo 1 DIETARY_SUPPLEMENT

42 day Crossover study design between Probiotic A and Placebo 1 (n = 25)

Probiotic A to Placebo 1

Placebo 2 to Probiotic B DIETARY_SUPPLEMENT

42 day Crossover study design between Placebo 2 and Probiotic B (n = 25)

Placebo 2 to Probiotic B

Probiotic B to Placebo 2 DIETARY_SUPPLEMENT

42 day Crossover study design between Probiotic B and Placebo 2 (n = 25)

Probiotic B to Placebo 2

Eligibility Criteria

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

You may qualify if:

• Signed Informed consent form
• Healthy adults aged 18-65 years
• Subclinical mild to moderate gastrointestinal complaints (GSRS-IBS score 20-45 at baseline)

You may not qualify if:

• Presence of a serious congenital anomaly or chronic medical condition that would contraindicate participation, including history of major gastrointestinal surgery, chronic gastrointestinal illness, abnormal intestinal anatomy or significant abdominal disorder
• Severe chronic illnesses
• Known immunodeficiency
• Use of immunosuppressive agents (corticosteroids, methotrexate…)
• Presence of severe immunodeficient family members as provided by subjects self-report
• Pregnancy, 6 months postpartum period or current breastfeeding
• Women of childbearing age planning pregnancy during the course of the study
• Not able to understand and comply with requirements of the study
• Use of probiotics, prebiotics, postbiotics, antibiotics within 3 weeks of study commencement

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• Merieux NutriSciences (China): collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo crossover to probiotic A Probiotic A crossover to Placebo Placebo crossover to probiotic B Probiotic B crossover to Placebo

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: June 20, 2024
• Study Start: June 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share