B. Lactis HN019 for Constipation-predominant Irritable Bowel Syndrome (IBS)

This prospective, double-blind, randomized, placebo-controlled clinical trial will
investigate the effects of 4-week B. lactis HN019 supplementation on whole gut transit time
and gastrointestinal symptoms in adults with constipation-predominant irritable bowel
syndrome (IBS-C). Participants who meet all study entry criteria will enter a 2-week run-in
period. Following successful completion of the run-in period, subjects will be randomized
to 4-week supplementation with B. lactis HN019 (10 billion cfu), B. lactis HN019 (1 billion
cfu), or placebo. The primary outcome of whole gut transit time will be evaluated with
abdominal x-rays on days 0 and 28. Secondary outcomes include IBS-specific questionnaires
(administered on days 0 and 28); abdominal pain severity, bowel movement frequency, stool
consistency, and adverse events (evaluated daily throughout the study); and overall product
satisfaction (evaluated at day 28). Physical activity questionnaires and 24-hour food
recalls will be completed periodically during the trial.

Inclusion Criteria:

- Age 18 to 70 years

- Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and
overweight)

- Meets the Rome III criteria for constipation-predominant irritable bowel syndrome
(IBS-C)

- 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 (including gastric bypass or lap band)

- 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

- Laxative or other constipation medication use within 2 weeks or at any time during
the trial

- 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 3 months of
screening

- Investigator believes that the participant may be uncooperative and/or noncompliant
and should therefore not participate in the study