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New treatment option for GI Issues
Official title The Effect of Humiome® Post LB on Gut COMFort in healthY Adult Volunteers
ClinicalTrials.gov ID: NCT06937814
What this study is testing
- What it's testing
- 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?
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Related to defecation.
- Associated with a change in frequency of stool.
See the full eligibility criteria
Who can 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.
- 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...
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant...
- 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
What rules you out
- 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...
- Related to defecation.
- Associated with a change in frequency of stool.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.