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RecruitingNCT06937814Updated Jul 8, 2026

The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers

An interventional study of Humiome ® Post LB and Placebo in GI Issues, Bowel Movements and Gastrointestinal Symptoms, sponsored by dsm-firmenich Switzerland AG. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by dsm-firmenich Switzerland AG · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • GI Issues
  • Bowel Movements
  • Gastrointestinal Symptoms

Keywords

  • Bowel movements
  • Gastrointestinal symptoms
  • Bristol stool scale
03

In context

Lead sponsor

dsm-firmenich Switzerland AG is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 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

Exclusion criteria

Exclusion Criteria:

  1. Failure to meet any one of the inclusion criteria.
  2. Females who are pregnant, lactating or wish to become pregnant during the study.
  3. Are lactose intolerant or have any other hypersensitivity/allergy to any of the components of the test product.

  4. 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:

    1. Related to defecation.
    2. Associated with a change in frequency of stool.
    3. 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.
  5. 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.
  6. Experience alarm features such as weight loss, rectal bleeding, or recent change in bowel habit (\<3 months), as assessed by the QI.
  7. Have taken antibiotics within the previous 2 months prior to the run-in period as assessed by QI (see Section 5.6.1).
  8. 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.
  9. 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.
  10. 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.
  11. Have planned a major surgery during the study period as assessed by the QI.
  12. Have a history of drug and/or alcohol abuse in the past 12 months at the time of enrolment.
  13. Alcohol intake average of >2 standard drinks per day as assessed by the QI
  14. Have made any major dietary changes in the past 3 months prior to run-in period.
  15. Currently consuming a vegetarian or vegan diet.
  16. Are planning a holiday over the study period that would alter dietary patterns as assessed by the QI.
  17. Have planned major changes in lifestyle (i.e. diet, weight loss program, exercise level, travelling) during the duration of the study.
  18. 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.
  19. Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to abstain for the duration of the study period.
  20. 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.
  21. Participation in other clinical research studies 30 days prior to the run-in period, as assessed by the QI.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
250 participants (estimated)

Study arms

  • Experimental
    Humiome® Post LB

    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.

    Dietary Supplement: Humiome ® Post LB

  • Placebo comparator
    Placebo

    170 mg/day of micro-crystalline cellulose

    Other: Placebo

Interventions

  • Dietary supplementHumiome ® Post LB

    Participants will be instructed to take one capsule with a glass of water after the first meal of the day.

  • OtherPlacebo

    Participants will be instructed to take one capsule with a glass of water after the first meal of the day.

06

What researchers measure

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 56

Secondary 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 28

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

Other 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 28

  2. 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 56

  3. 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 28

  4. 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 56

  5. The difference after Humiome® Post LB and Placebo in perceived benefits

    The difference at week 8 (Day 56) between Humiome® Post LB and Placebo in perceived benefits as assessed by a 5-point Likert scale

    Time frame: Day 0 to 56

  6. To evaluate in healthy volunteers the effect of daily consumption of 170 mg Humiome® Post LB on safety variables

    To evaluate in healthy volunteers the effect of daily consumption of 170 mg Humiome® Post LB on adverse events and serious adverse events.

    Time frame: Day 0 to 56

  7. Clinically relevant changes in blood pressure

    Clinically relevant changes in blood pressure (BP) after supplementation from baseline (visit 2) at end of the study (visit 4).

    Time frame: Day 0 to 56

  8. Clinically relevant changes in heart rate

    Clinically relevant changes in heart rate after supplementation from baseline (visit 2) at end of the study (visit 4).

    Time frame: Day 0 to 56

07

Study locations

1 of 1 sites recruiting
  • KGK Science Inc.
    London, Ontario, Canada
    • Erin Lewis, PhD · Contact · elewis@kgkscience.com · 1-226-242-4551
    • David Crowley, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06937814
Lead sponsor
dsm-firmenich Switzerland AG
Collaborators
KGK Science Inc.
Responsible party
Sponsor
First posted
Apr 22, 2025
Start date
Jun 16, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Jul 8, 2026

Study contacts

Erin Lewis, PhD
Contact
elewis@kgkscience.com
1-226-242-4551 ext. 248
David Crowley, MD
principal investigator · KGK Science Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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