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
Qualifiers
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
Treatments tested in this trial
- Humiome ® Post LB
- Placebo
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
dsm-firmenich Switzerland AG
Lead sponsor
KGK Science Inc.
Collaborator
Source ClinicalTrials.gov