Assessment of immune-modulating efficacy of two probiotic strains in healthy adults

Not Applicable

• Conditions: immune health; gastrointestinal health; Inflammatory and Immune System - Normal development and function of the immune system; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12623000045617
• Lead Sponsor: ew Zealand Institute for Plant & Food Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-16
• Last Update Posted: 27 November 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Healthy adults 18-50 years at recruitment

Exclusion Criteria

Blood parameters out of normal health ranges; pregnant or breastfeeding, long term chronic illnesses, daily consumption of probiotics, antibiotic treatment at time of study, recent changes in bowel habit, weight loss, blood in stools anal fissures, bleeding hemorrhoids, and family history of gastrointestinal tract cancer or inflammatory bowel disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Participant immune status assessed by measuring serum proinflammatory cytokines (interkeukins)[ Baseline, and 4 weeks after intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Participant immune status assessed by measuring serum T cells[ Baseline and 4 weeks after intervention commencement];Bowel function will be measured using the daily bowel habit diary and Bristol Stool Scale [ Daily for 4 weeks];Gastrointestinal comfort will be determined weekly using the Gastrointestinal Symptom Rating Scale (GSRS)[ Weekly for 6 weeks (2 weeks run-in, 4 weeks intervention)];Changes in appetite and food choices will be determined using weekly 3-day food diary and dietary fructan frequency questionnaires[ Weekly for 4 weeks of intervention];Changes in how the participants feel will be measured daily using the Depression, Anxiety, Stress Scale-21 (DASS-21).[ Daily for 4 weeks of intervention];Changes in happiness will be measured daily using the Oxford Happiness Questionnaire[ Daily for 4 weeks of intervention];Collection of stool samples for measuring markers of gut comfort and health[ Beginning and end of 4 weeks of the intervention]