New supplement aims to ease bloating and irregularity
NCT ID NCT06937814
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This study tests whether an 8-week course of Humiome Post LB, a dietary supplement, can improve bowel movements and reduce gastrointestinal discomfort in healthy adults who have mild issues like bloating or irregularity. About 250 participants will take either the supplement or a placebo daily. The main goal is to see if bowel frequency improves compared to placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Humiome Post LB (a dietary supplement)
- What this could lead to
- If it works, this could offer a natural supplement option for improving bowel regularity and reducing bloating or cramping.
- What could go wrong
- This is an early-stage trial with no phase, so results may not be conclusive. The supplement may not outperform placebo, and effects may be small.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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KGK Science Inc.
RECRUITINGLondon, Ontario, Canada
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