The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers
Trial Parameters
Brief Summary
The goal of this double-blind, randomized placebo-controlled study is to evaluate the effect of an 8-week supplementation of Humiome ® Post LB (170 mg) on bowel movements in healthy adult volunteers compared to Placebo adjusted on baseline. The main question\[s\] it aims to answer \[is/are\]: Does Humiome ® Post LB improve bowel movements with self-reported GI issues? Participants will be provided Humiome ® Post LB (170 mg) for 8 weeks and asked to complete a study diary, questionnaires, and stool samples.
Eligibility Criteria
Inclusion Criteria: 1. Be able to give written informed consent. 2. Self-reported gastrointestinal issues defined as 10-20 bowel movements per week and a score of 5-6 for ≥20% of stools based on the BSS in the 2 weeks prior to baseline, as assessed by the Qualified Investigator (QI). 3. Self-reported GI issues such as bloating, mild cramping, and urgency, as assessed by the QI. 4. Be between 18 and 75 years of age, inclusive. 5. Have a BMI of between 18.5 - 29.9 kg/m2, inclusive. 6. Self-reported stable body weight (\<5% change) over the past 3 months. 7. Be in general good health, as determined by the QI. 8. Willing to avoid consuming prebiotic, probiotic, postbiotics, fiber-rich and dietary supplements, anti-diarrheal and anti-constipation medication until the end of the study (see Section 5.6). 9. Willing to maintain current dietary habits and lifestyle, including level of physical activity, allowed medication/supplements habits for the duration of the study. 10. Females not of chil