GI IssuesNCT06937814
The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers
A study testing Humiome ® Post LB in people with GI Issues and Bowel Movements, run by dsm-firmenich Switzerland AG at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- GI Issues, Bowel Movements, Gastrointestinal Symptoms
- What is being tested?
- Humiome ® Post LB
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jun 2025to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Have a BMI of between 18.5 - 29.9 kg/m2, inclusive.
- Self-reported stable body weight (<5% change) over the past 3 months.
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- Be in general good health, as determined by the QI.
- 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).
- Willing to maintain current dietary habits and lifestyle, including level of physical activity, allowed medication/supplements habits for the duration of the study.
- Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
- Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Abstinence and agrees to use contraception if planning on becoming sexually active during the study
Who cannot join
- 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.
- Meeting Irritable Bowel Syndrome (IBS) diagnostic criteria as defined by Rome IV criteria, i.e. having recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
- Related to defecation.
- Associated with a change in frequency of stool.
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- Associated with a change in form (appearance) of stool. Criteria need to be fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
- Have suffered from diarrhea (defined as ≥3 bowel movements per day and 6-7 on BSS) at any time two weeks prior to run-in, as assessed by the QI.
- Experience alarm features such as weight loss, rectal bleeding, or recent change in bowel habit (<3 months), as assessed by the QI.
- Have taken antibiotics within the previous 2 months prior to the run-in period as assessed by QI (see Section 5.6.1).
- Unstable hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg). Treatment on a stable dose of medication for at least 3 months will be considered by the QI.
- Known history of or ongoing HIV, hepatitis or clinically important, as judged by the QI, endocrine (including Type 1 or Type 2 diabetes mellitus), cardiovascular (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), pulmonary, biliary conditions.
- Current or history of any significant diseases of the gastrointestinal tract (including but not limited to Crohn's disease, ulcerative colitis, celiacs disease, colectomy), as assessed by the QI.
- Have planned a major surgery during the study period as assessed by the QI.
- Have a history of drug and/or alcohol abuse in the past 12 months at the time of enrolment.
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- Have made any major dietary changes in the past 3 months prior to run-in period.
- Currently consuming a vegetarian or vegan diet.
- Are planning a holiday over the study period that would alter dietary patterns as assessed by the QI.
- Have planned major changes in lifestyle (i.e. diet, weight loss program, exercise level, travelling) during the duration of the study.
- Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period.
- Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to abstain for the duration of the study period.
- Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant.
- Participation in other clinical research studies 30 days prior to the run-in period, as assessed by the QI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
KGK Science Inc.
London, Ontario
Erin Lewis, PhD, 1-226-242-4551 ext. 248, elewis@kgkscience.com
David Crowley, MD
About this study
Official title: The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers: a Double-blind, Randomized Placebo-controlled Study
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.
- Conditions
- GI Issues, Bowel Movements, Gastrointestinal Symptoms
- Being tested
- Humiome ® Post LB, Placebo
- Keywords
- Bowel movements, Gastrointestinal symptoms, Bristol stool scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humiome ® Post LBDietary supplement
Participants will be instructed to take one capsule with a glass of water after the first meal of the day.
PlaceboOther
Participants will be instructed to take one capsule with a glass of water after the first meal of the day.
| Study group | Role | What they receive |
|---|---|---|
| Humiome® Post LB | Experimental | A postbiotic comprised of inactivated Limosilactobacillus fermentum (CNCM I-2998) and Lactobacillus delbrueckii (CNCM I-4831), together referred to as Lactobacillus LB, and fermented culture medium. Receives: Dietary Supplement: Humiome ® Post LB |
| Placebo | Placebo comparator | 170 mg/day of micro-crystalline cellulose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 0 to 56
Secondary outcomes (15)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 to 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start16 Jun 2025
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GI IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- dsm-firmenich Switzerland AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937814
- Sponsor's protocol ID
- 2024-10-24-POSTL
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers: a Double-blind, Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT06937814
- Acronym / sponsor ID
- 2024-10-24-POSTL
- Conditions
- GI Issues, Bowel Movements, Gastrointestinal Symptoms
- Keywords
- Bowel movements, Gastrointestinal symptoms, Bristol stool scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- dsm-firmenich Switzerland AGIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Humiome® Post LB | Experimental | Dietary Supplement: Humiome ® Post LBA postbiotic comprised of inactivated Limosilactobacillus fermentum (CNCM I-2998) and Lactobacillus delbrueckii (CNCM I-4831), together referred to as Lactobacillus LB, and fermented culture medium. |
| Placebo | Placebo comparator | Other: Placebo170 mg/day of micro-crystalline cellulose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
- Have a BMI of between 18.5 - 29.9 kg/m2, inclusive.
Key exclusion criteria (24 listed)
- 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.
- Meeting Irritable Bowel Syndrome (IBS) diagnostic criteria as defined by Rome IV criteria, i.e. having recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria:
- Have suffered from diarrhea (defined as ≥3 bowel movements per day and 6-7 on BSS) at any time two weeks prior to run-in, as assessed by the QI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humiome ® Post LBParticipants will be instructed to take one capsule with a glass of water after the first meal of the day. | Dietary supplement | Humiome® Post LB |
| PlaceboParticipants will be instructed to take one capsule with a glass of water after the first meal of the day. | Other | Placebo |
Primary outcome
To evaluate the effect of Humiome ® Post LB (170 mg) supplementation on bowel movements in healthy adult volunteers compared to Placebo
Time frame: Day 0 to 56
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).
15 secondary outcomes
The difference in frequency of bowel movements 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.
Time frame: Day 0 to 28
The difference in frequency of bowel movements after Humiome® Post LB and Placebo compared to baseline.
Time frame: Day 0 to 56
The difference between Humiome® Post LB and Placebo in stool consistency.
Time frame: Day 0 to 28
The difference between Humiome® Post LB and Placebo in stool consistency.
Time frame: Day 0 to 56
The difference between Humiome® Post LB and Placebo in quality of life
Time frame: Day 0 to 28
The difference between Humiome® Post LB and Placebo in quality of life
Time frame: Day 0 to 56
The difference after Humiome® Post LB and Placebo compared to baseline in stool consistency
Time frame: Day 0 to 28
The difference after Humiome® Post LB and Placebo compared to baseline in stool consistency
Time frame: Day 0 to 56
The difference after Humiome® Post LB and Placebo compared to baseline in quality of life
Time frame: Day 0 to 28
The difference after Humiome® Post LB and Placebo compared to baseline in quality of life
Time frame: Day 0 to 56
The difference between Humiome® Post LB and Placebo in fecal microbial composition
Time frame: Day 0 to 56
The difference between Humiome® Post LB and Placebo in fecal microbial composition
Time frame: Day 0 to 56
The difference after Humiome® Post LB and Placebo compared to baseline in fecal microbial composition
Time frame: Day 0 to 56
The difference after Humiome® Post LB and Placebo compared to baseline in fecal bacterial diversity
Time frame: Day 0 to 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humiome ® Post LB in people with GI Issues and Bowel Movements, run by dsm-firmenich Switzerland AG at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Lewis, PhD (1-226-242-4551 ext. 248, elewis@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of Humiome ® Post LB (170 mg) supplementation on bowel movements in healthy adult volunteers compared to Placebo (time frame: Day 0 to 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.