Status:
COMPLETED
Influence of a Delivery System on the Efficacy of a Probiotic Intervention
Lead Sponsor:
Penn State University
Collaborating Sponsors:
Dairy Management Inc.
Conditions:
Delayed Transit Time
Irregular Bowel Function
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
In the proposed work we will evaluate the efficacy of a probiotic bacterium (Bifidobacterium animalis subsp. lactis BB12) delivered in a yogurt smoothie (organism to be added before or after fermentat...
Detailed Description
Probiotics (health-promoting bacteria) are often considered "functional ingredients" that act independently of the matrix used to deliver them to the human host. This thinking ignores the impact the d...
Eligibility Criteria
Inclusion
- Generally healthy
- Men and women
- 18-40 years of age
- Body mass index between 20 and 35 kg/m\^2
- Persons with irregular bowel function as determined using the Rome III criteria (1) which is used to classify functional gastrointestinal disorders.
- Increased gastrointestinal transit time \> 60 hours.
Exclusion
- Smoking and/or use of other tobacco products
- Blood pressure greater than 140/90 mm Hg
- A history of myocardial infarction, stroke, diabetes mellitus, liver disease, kidney disease and thyroid disease (unless controlled by medication and blood results within the previous 6 months are provided).
- Lactation, pregnancy or desire to become pregnant during the study
- Use of cholesterol-lowering medication
- Refusal to discontinue intake of putative cholesterol-lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, phytoestrogens, stanol/sterol supplemented foods
- Refusal to discontinue probiotics,nutritional supplements, herbs or vitamins
- Vegetarianism/Veganism
- Lactose intolerance
- Clinical diagnosis of Inflammatory Bowel Disease (IBD), e.g. Crohn's Disease or ulcerative colitis
- Excessive alcohol consumption (\> 14 standard drinks per week)
- Chronic use of anti-inflammatory medications (unless able to discontinue)
- Individuals taking stool softeners or enemas on a regular basis.
- Allergy to polyvinyl chloride (PVC) or any other type of plastic
- Individuals with a bowel transit time of \< 60 hours at time of screening
- Individuals with swallowing disorders or dysphagia to food or pills
- Suspected strictures, fistulas, or physiological GI Obstruction
- GI surgery within the past three months
- Refusal to agree to give blood or plasma for the length of the study.
- Note: If a participant experiences a delay in passing the capsule (beyond five days) they will be treated accordingly and excluded from future participation in the study.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01399996
Start Date
April 1 2012
End Date
August 1 2014
Last Update
August 21 2023
Active Locations (1)
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1
Penn State University
University Park, Pennsylvania, United States, 16802