Testing Humiome ® Post LB against a placebo for GI issues

Exclusion

• −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.
• −Are lactose intolerant or have any other hypersensitivity/allergy to any of the components of the test product.
• −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.
• −Failure to meet any one of the inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →.
• −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.
• −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.
• −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 periodRun-in periodA short trial period before the study proper begins.Read more → 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.
• −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 a history of drug and/or alcohol abuse in the past 12 months at the time of enrolmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
• −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.
• −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.
• −Females who are pregnant, lactating or wish to become pregnant during the study.
• −Have planned a major surgery during the study period as assessed by the QI.
• −Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washoutWashout periodA gap with no treatment, so the previous one clears your system.Read more → and abstain for the duration of the study period.