Determination of the Safety and Efficacy of Two Probiotic Strains
NCT Number: NCT06466174
Acronym: CODECS
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gastrointestinal Dysfunction
Interventions: DIETARY_SUPPLEMENT: Placebo 1 to Probiotic A|DIETARY_SUPPLEMENT: Probiotic A to Placebo 1|DIETARY_SUPPLEMENT: Placebo 2 to Probiotic B|DIETARY_SUPPLEMENT: Probiotic B to Placebo 2
Sponsor: The Archer-Daniels-Midland Company
Collaborators: Merieux NutriSciences (China)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-06
Completion Date: 2026-05

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.

Primary Outcome Measures: 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 Outcome Measures: 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, Baseline vs Week 6|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, Baseline vs Week 6|Incidence of urinary tract infections, Incidence of urinary tract infections, as captured by incidence of urinary tract infections as reported by clinician/PI, Baseline vs Week 6|Duration of urinary tract infections, Duration of urinary tract infections, as captured by duration of urinary tract infections as reported by clinician/PI, Baseline vs Week 6
Other Outcome Measures: 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, Baseline vs Week 6|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), Baseline vs Week 6|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., Baseline vs Week 6|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., Baseline vs Week 6|Regularity of defecation, Regularity of defecation as captured by daily diary, Baseline vs Week 6|Changes in serum short chain fatty acid levels, Changes in serum short chain fatty acids (SCFA's) including acetate, propionate and butyrate in micromol/L), Baseline vs Week 6|Changes in serum amino acids levels, Changes in serum amino acids levels including the essential amino acids histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, and valine; and the non-essential amino acids alanine, arginine, asparagine, aspartic acid, cysteine, glutamic acid, glutamine, glycine, proline, serine, and tyrosine in micromol/L, Baseline vs Week 6