Phase 3
N=224
B. Lactis HN019 for Functional Constipation
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01463293 ↗Enrolled (actual)
224
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Whole Gut Transit Time
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- B. lactis HN019 (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fonterra Research Centre
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whole Gut Transit Time |
— | — |
| SECONDARY Patient Assessment of Constipation Symptoms (PAC-SYM) |
— | — |
| SECONDARY Patient Assessment of Constipation QoL (PAC-QoL) |
— | — |
| SECONDARY Bowel Function Index |
— | — |
| SECONDARY Adequate Relief of Constipation (Yes/no) |
— | — |
| SECONDARY Bowel Movement Frequency |
— | — |
| SECONDARY Stool Consistency |
— | — |
| SECONDARY Overall Product Satisfaction |
— | — |
| SECONDARY Adverse Event Frequency |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT01463293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.