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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
Participants will be instructed to take one capsule with a glass of water after the first meal of the day.
Participants will be instructed to take one capsule with a glass of water after the first meal of the day.
KGK Science Inc.
London, Ontario, Canada
RECRUITINGTo evaluate the effect of Humiome ® Post LB (170 mg) supplementation on bowel movements in healthy adult volunteers compared to Placebo
To evaluate the effect of Humiome ® Post LB (170 mg) supplementation on the difference in frequency of bowel movements as assessed by the Bowel Habits Diary (BHD) in healthy adult volunteers compared to Placebo adjusted on baseline at week 8 (Day 56; between group comparison).
Time frame: Day 0 to 56
The difference in frequency of bowel movements between Humiome® Post LB and Placebo
The difference in frequency of bowel movements as assessed by the BHD at week 4 (Day 28) between Humiome® Post LB and Placebo
Time frame: Day 0 to 28
The difference in frequency of bowel movements after Humiome® Post LB and Placebo compared to baseline.
The difference in frequency of bowel movements as assessed by the BHD after Humiome® Post LB and Placebo at weeks 4 (Day 28) compared to baseline.
Time frame: Day 0 to 28
The difference in frequency of bowel movements after Humiome® Post LB and Placebo compared to baseline.
The difference in frequency of bowel movements as assessed by the BHD after Humiome® Post LB and Placebo at week 8 (Day 56) compared to baseline.
Time frame: Day 0 to 56
The difference between Humiome® Post LB and Placebo in stool consistency.
The difference at weeks 4 (Day 28) between Humiome® Post LB and Placebo in stool consistency as assessed by the Bristol Stool Scale.
Time frame: Day 0 to 28
The difference between Humiome® Post LB and Placebo in stool consistency.
The difference at weeks 8 (Day 56) between Humiome® Post LB and Placebo in stool consistency as assessed by the Bristol Stool Scale
Time frame: Day 0 to 56
The difference between Humiome® Post LB and Placebo in quality of life
The difference at weeks 4 (Day 28) between Humiome® Post LB and Placebo in quality of life as assessed by the RAND Short Form Health Survey 36 (SF-36).
Time frame: Day 0 to 28
The difference between Humiome® Post LB and Placebo in quality of life
The difference at weeks 8 (Day 56) between Humiome® Post LB and Placebo in quality of life as assessed by the RAND Short Form Health Survey 36 (SF-36).
Time frame: Day 0 to 56
The difference after Humiome® Post LB and Placebo compared to baseline in stool consistency
The difference after Humiome® Post LB and Placebo at weeks 4 (Day 28) compared to baseline in stool consistency as assessed by the Bristol Stool Scale
Time frame: Day 0 to 28
The difference after Humiome® Post LB and Placebo compared to baseline in stool consistency
The difference after Humiome® Post LB and Placebo at weeks 8 (Day 56) compared to baseline in stool consistency as assessed by the Bristol Stool Scale
Time frame: Day 0 to 56
The difference after Humiome® Post LB and Placebo compared to baseline in quality of life
The difference after Humiome® Post LB and Placebo at weeks 4 (Day 28) compared to baseline in quality of life as assessed by the RAND Short Form Health Survey 36 (SF-36).
Time frame: Day 0 to 28
The difference after Humiome® Post LB and Placebo compared to baseline in quality of life
The difference after Humiome® Post LB and Placebo at weeks 8 (Day 56) compared to baseline in quality of life as assessed by the RAND Short Form Health Survey 36 (SF-36).
Time frame: Day 0 to 56
The difference between Humiome® Post LB and Placebo in fecal microbial composition
The difference at week 8 (Day 56) between Humiome® Post LB and Placebo in fecal microbial composition (i.e., relative abundance of taxa) as assessed by shallow shotgun sequencing.
Time frame: Day 0 to 56
The difference between Humiome® Post LB and Placebo in fecal microbial composition
The difference at week 8 (Day 56) between Humiome® Post LB and Placebo in fecal bacterial diversity as assessed by shallow shotgun sequencing.
Time frame: Day 0 to 56
The difference after Humiome® Post LB and Placebo compared to baseline in fecal microbial composition
The difference after Humiome® Post LB and Placebo at week 8 (Day 56) compared to baseline in fecal microbial composition (i.e., relative abundance of taxa) as assessed by shallow shotgun sequencing.
Time frame: Day 0 to 56
The difference after Humiome® Post LB and Placebo compared to baseline in fecal bacterial diversity
The difference after Humiome® Post LB and Placebo at week 8 (Day 56) compared to baseline in fecal bacterial diversity as assessed by shallow shotgun sequencing.
Time frame: Day 0 to 56
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