B. Lactis HN019 for Functional Constipation

Completed · Phase 3 · Has a placebo group

Conditions studied: Constipation

In brief

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

Key facts

Study ID

NCT01463293

Run by

Fonterra Research Centre

People needed

224

Starts

2012-03-01

Expected to finish

2013-05-01

Last updated by the study team

2014-07-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arrowhead Family Health Center — Glendale, Arizona, United States
• Diagnamics, Inc. — Encinitas, California, United States
• Digestive & Liver Disease Specialists — Garden Grove, California, United States
• StayWell Research — Northridge, California, United States
• Sprim ALS — San Francisco, California, United States
• Westlake Medical Research — Westlake Village, California, United States
• Research Across America — Carrollton, Texas, United States
• Research Across America — Dallas, Texas, United States
• Discovery Clinical Trials South Main — Houston, Texas, United States
• Research Across America — Katy, Texas, United States
• Village Health Partners — Plano, Texas, United States
• North Texas Family Medicine — Plano, Texas, United States

Full record on ClinicalTrials.gov

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