The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
Sponsordsm-firmenich Switzerland AG
About this trial
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
This trial accepts healthy volunteersQualifiers
Be able to give written informed consent.
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).
Self-reported GI issues such as bloating, mild cramping, and urgency, as assessed by the QI.
Be between 18 and 75 years of age, inclusive.
Disqualifiers
Failure to meet any one of the inclusion criteria.
Females who are pregnant, lactating or wish to become pregnant during the study.
Are lactose intolerant or have any other hypersensitivity/allergy to any of the components of the test product.
Related to defecation.
Trial design
Design model
Parallel
Treatments tested in this trial
Humiome ® Post LB
Dietary supplementParticipants will be instructed to take one capsule with a glass of water after the first meal of the day.
Placebo
Other interventionParticipants will be instructed to take one capsule with a glass of water after the first meal of the day.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Humiome® Post LBExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To 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 56Secondary outcomes
1
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 282
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 283
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 564
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 28Other outcomes
1
The difference between Humiome® Post LB and Placebo in GI symptoms
The difference at weeks 4 (Day 28) between Humiome® Post LB and Placebo in GI symptoms as assessed by the Gastrointestinal Symptom Rating Scale (GSRS)
Time frame
Day 0 to 282
The difference between Humiome® Post LB and Placebo in GI symptoms
The difference at weeks 8 (Day 56) between Humiome® Post LB and Placebo in GI symptoms as assessed by the Gastrointestinal Symptom Rating Scale (GSRS)
Time frame
Day 0 to 563
The difference after Humiome® Post LB and Placebo compared to baseline in GI symptoms
The difference after Humiome® Post LB and Placebo at weeks 4 (Day 28) compared to baseline in GI symptoms as assessed by the Gastrointestinal Symptom Rating Scale (GSRS)
Time frame
Day 0 to 284
The difference after Humiome® Post LB and Placebo compared to baseline in GI symptoms
The difference after Humiome® Post LB and Placebo at weeks 8 (Day 56) compared to baseline in GI symptoms as assessed by the Gastrointestinal Symptom Rating Scale (GSRS)
Time frame
Day 0 to 56Sponsors and contacts
Click on the lead sponsor to view all of their trials.
dsm-firmenich Switzerland AG
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov