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.
Signed Informed consent form
Healthy adults aged 18-65 years
Subclinical mild to moderate gastrointestinal complaints (GSRS-IBS score 20-45 at baseline)
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…)
Crossover
Placebo 1 to Probiotic A
Dietary supplement42 day Crossover study design between Placebo 1 and Probiotic A (n = 25)
Probiotic A to Placebo 1
Dietary supplement42 day Crossover study design between Probiotic A and Placebo 1 (n = 25)
Placebo 2 to Probiotic B
Dietary supplement42 day Crossover study design between Placebo 2 and Probiotic B (n = 25)
Probiotic B to Placebo 2
Dietary supplement42 day Crossover study design between Probiotic B and Placebo 2 (n = 25)
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
Incidence of upper respiratory tract symptoms
Incidence of upper respiratory tract symptoms, as captured by incidence of upper respiratory tract as reported by clinician/PI
Duration of upper respiratory tract symptoms
Duration of upper respiratory tract symptoms, as captured by duration of upper respiratory tract as reported by clinician/PI
Incidence of urinary tract infections
Incidence of urinary tract infections, as captured by incidence of urinary tract infections as reported by clinician/PI
Duration of urinary tract infections
Duration of urinary tract infections, as captured by duration of urinary tract infections as reported by clinician/PI
Change in Stool consistency
To evaluate the difference in stool consistency as determined by daily Bristol stool chart scale captured in daily diary. The Bristol stool chart ranges from 1-7, with 1,2 being hard and solid and 6,7 being loose and watery. This readout will be the change in stool consistency towards types 3,4 and 5
Questionnaire regarding general health
General health questionnaire regarding mood, sleep, energy, concentration and changes in appetite. This is based on a Likert scale ranging from 0 (no effect) to 7 (severe)
Changes in microbiome readouts
To determine if there are any changes in alpha and beta diversity in the microbiome using 16S rRNA sequencing ( a common methodology used in assessing microbiome readouts) between placebo and probiotic treatment.
Changes in blood immune biomarkers
To determine if there are any changes in biomarkers relating to immune markers including IL-6 (IL interleukin), IL-10, TNFalpha, IFNgamma in pg/mL serum.
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The Archer-Daniels-Midland Company
Lead sponsor
Merieux NutriSciences (China)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
