b. lactis hn019 for functional constipation

Conditions: Constipation

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.

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 functional constipation. 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.

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

Keywords: constipation probiotic functional constipation ibs-c