Influence of a Delivery System on the Efficacy of a Probiotic Intervention
Completed · Phase 1
Conditions studied: Delayed Transit Time, Irregular Bowel Function
In brief
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 fermentation) or as a supplement (tablet) by assessing 1) bowel habits (transit time); 2) the ecology of the bacterial community in the GIT; and 3) immune status of healthy human volunteers. In addition to providing information about the relative efficacy of the delivery vehicles on probiotic function it will provide novel information about the influence of the yogurt smoothie alone (control) on all the parameters measured.
Key facts
- Study ID
- NCT01399996
- Run by
- Penn State University
- People needed
- 36
- Starts
- 2012-04-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2023-08-21
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Penn State University — University Park, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.