Status:
COMPLETED
Effects of Administration of L.Plantarum WCFS1, L.Plantarum CIP104448, L.Plantarum CIP104450 on Small Intestinal Mucosa
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Gastro Intestinal Infection
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The design of this study conforms to a randomized double-blind placebo-controlled cross-over design. The objective of the study is to assess the effect of three probiotics (Lactobacillus plantarum WC...
Eligibility Criteria
Inclusion
- Based on medical history and previous self-admitted examination, no gastrointestinal complaints can be defined.
- Age between 18 and 65 years.
- BMI between 20 and 30 kg/m2.
Exclusion
- History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
- Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing.
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study.
- Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator).
- Pregnancy, lactation.
- Excessive alcohol consumption (\>20 alcoholic consumptions per week).
- Smoking.
- Blood donation within 3 months before or after the study period.
- Self-admitted HIV-positive state.
- Known hypersensitivity or history of allergic reactions towards intake of non-steroidal anti-inflammatory drugs (NSAIDs) or non- or low caloric sweeteners of any kind.
- History of any side effects towards intake of pro- or prebiotic supplements of any kind.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01456767
Start Date
October 1 2011
Last Update
July 19 2012
Active Locations (1)
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1
Health, Medicine and Life Sciences
Maastricht, Limburg, Netherlands, 6200 MD