B. Lactis HN019 for Functional Constipation
Condition: Constipation
MeSH terms: Constipation
Intervention: B. lactis HN019; B. lactis HN019; Placebo
Intervention description: Capsule containing 10 billion cfu B. lactis HN019 once a day; Capsule containing 1 billion cfu B. lactis HN019 once a day; Capsule containing no probiotic once a day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: constipation; probiotic; functional constipation; IBS-C

Summary:

      This study will investigate the effects of 4-week probiotic supplementation on whole gut
      transit time and gastrointestinal symptoms in adults with functional constipation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 to 70 years

          -  Body mass index between 18.5 and 34.9 kg/m2

          -  Self-reported unsatisfactory defecation due to infrequent stools and/or difficult
             stool passage, which includes at least one of the following: symptoms of straining,
             difficulty expelling stool, a sense of incomplete evacuation, hard or lumpy stools,
             prolonged time to stool, or a need for manual maneuvers to pass stool.

          -  Estimated stool consistency < 4.0 on BSSF (self-reported at screening) within the past
             month prior to enrollment.

          -  Ability of the participant (in the investigator's opinion) to comprehend the full
             nature and purpose of the study including possible risks and side effects

          -  Consent to the study and willing to comply with study product and methods

        Exclusion Criteria:

          -  Major gastrointestinal complication (e.g. Crohn's disease, ulcer)

          -  Prior abdominal surgery that, in the opinion of the investigator, may present a risk
             for the subject or confound study results

          -  Clinically significant underlying systemic illness that may preclude the subject's
             ability to complete the trial or that may confound the study outcomes (e.g. bowel
             cancer, prostate cancer, terminal illness)

          -  Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2
             weeks of screening and throughout the trial other than the provided study products

          -  Non-laxative constipation medication use within 2 weeks of screening, laxative use
             within 48 hours of screening (rescue medication allowed for intolerable symptoms
             during study)

          -  Daily use of anticholinergic agents, opioid analgesics, calcium supplements,
             calcium-channel blockers, and NSAIDs

          -  Anticipated major dietary or exercise changes during the study

          -  Systemic steroid use

          -  Eating disorder

          -  Contraindication to dairy products (e.g., intolerance to lactose or any substance in
             the study product)

          -  History of alcohol, drug, or medication abuse

          -  Pregnant or lactating female, or pregnancy planned during study period

          -  Participation in another study with any investigational product within 30 days of
             screening

          -  Investigator believes that the participant may be uncooperative and/or noncompliant
             and should therefore not participate in the study