Status:
COMPLETED
Effects of Probiotic Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Constipation.
Lead Sponsor:
Danisco Sweeteners Oy
Collaborating Sponsors:
Eurofins Optimed
Conditions:
Constipation
Gastrointestinal Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
To determine if Bifidobacterium lactis HN109 improves transit time and gastrointestinal symptoms in adults with constipation.
Detailed Description
Constipation is a commonly diagnosed gastrointestinal disorder with an estimated prevalence in the general population of 12-19%, which results in lower quality of life and significant healthcare costs...
Eligibility Criteria
Inclusion
- 1\. Age 18 to 70 years
- Body mass index between 18.5 and 34.9 kg/m2
- 3\. Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):
- Must meet 2 or more of the following criteria:
- Straining during at least 25% of defecations
- Lumpy or hard stools in at least 25% of defecations
- Sensation of incomplete evacuation for at least 25% of defecations
- Sensation of anorectal obstruction/blockage for at least 25% of defecations+ Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
- Fewer than three defecations per week
- Loose stools are rarely present without the use of laxatives
- Insufficient criteria for irritable bowel syndrome
Exclusion
- Major gastrointestinal complication (e.g. Crohn's disease, ulcer)
- 2\. Prior abdominal surgery that, in the opinion of the investigator, may present a risk for the participant or confound study results
- 3\. Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness)
- 4\. 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
- 5\. Laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study)
- 6\. Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-Hydroxytryptamine#-antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or nonsteroidal antiinflammatory drugs), within 1 month before screening.
- 7\. Anticipated major dietary or exercise changes during the study
- 8\. Systemic steroid use, within 1 month before screening.
- 9\. Eating disorder
- 10\. Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product)
- 11\. History of alcohol, drug, or medication abuse
- 12\. Pregnant or lactating female, or pregnancy planned during study period.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT02189707
Start Date
August 1 2014
End Date
April 1 2015
Last Update
May 7 2015
Active Locations (1)
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1
EUROFINS OPTIMED Clinical Research
Gières, France, 38610