Back to resultsThe Effect of a Probiotic Intervention in Healthy Subjects and Patients With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
probiotics
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring probiotics, atopic dermatitis, immune system, human, Lactobacillus, Bifidobacterium, healthy subjects
Eligibility Criteria
Inclusion Criteria:
Healthy subjects:
- No allergic asthma
- No allergic rhinoconjunctivitis
- No food allergies
- Exclusion of atopic diathesis (< 7 points in Erlangen atopy score)
Patients with AD:
- Clear diagnosis of atopic dermatitis (> 10 points in the Erlangen atopy score) or flexural eczema or pruritis for at least 12 months (recidivating or permanent)
- SCORAD 5-30 (minor or medium AD)
- Willingness to apply for the duration of the study exclusively the cosmetic products recommended by the accompanying doctor and to use the recommended class II corticosteroid (Advantan) as further therapy of AD (for example during an episode)
Exclusion Criteria:
- Pregnancy, lactation
- Immune suppressive or cytostatic therapy or systemic steroids < 1 month before the first intake
- Phototherapy or systemic therapy of AD < 1 month before the first intake
- Active infections of the skin
- Relevant asthma disease, which must be treated with inhalative corticoids (FEV1 < 70 %)
- Patients with an indigestibility of/allergy against the components of milk/lactose intolerance (previously known or detected in the allergy test)
- Patients under long-term treatment with systemic steroids, depot steroids, long-acting antihistamines, tranquilizers, psychopharmaceuticals
- Intake of antihistamines, psychopharmaceuticals with antihistaminic effect and application of steroid containing cream to the forearms within the past 7 days before prick testing resp. treatment of the patient with Astemizol (Hismanal) within 4 weeks before the test. Such patients must be excluded from the study because of the long half-life of the medicament.
- Acute or chronic symptomatic heart disease or severe internistic diseases
- Autoimmune diseases, immune deficiencies (including immune suppressive treatment)
- Immune-complex-induced immunopathies or malignant tumors
- Abuse of alcohol, drugs or medicaments
Sites / Locations
- University of Jena, Institute of Nutrition, Department of Nutritional Physiology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Probiotic
Arm Description
intervention
Outcomes
Primary Outcome Measures
SCORAD change in patients with AD taken at baseline and after 4 and 8 weeks, respectively -change in phagocytic and oxidative burst activity of monocytes and granulocytes at baseline and after 8 weeks
Secondary Outcome Measures
cellular and humoral immunological parameters (CD's; Interleukins); detection of bacterial species in faecs, faecal short-chain fatty acids, blood lipids
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00550472
Brief Title
The Effect of a Probiotic Intervention in Healthy Subjects and Patients With Atopic Dermatitis
Official Title
Intervention Study on the Effects of a Probiotic Yoghurt Drink on the Immune System and Further Physiological Parameters in Patients With Atopic Dermatitis and Healthy Persons
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Jena
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study was performed to investigate the effects of a probiotic supplementation containing Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 and Bifidobacterium animalis subsp. lactis DGCC 420 (B. lactis 420) on clinical, immunological and faecal parameters in healthy volunteers and in patients with atopic dermatitis (AD).
Detailed Description
Recent studies suggest that oral bacteriotheraphy with probiotic bacteria might be useful to alleviate atopic dermatitis in infants. There are few indications about the effect of probiotics in the management of atopic dermatitis in adults.
As a precondition for participating in this study, the subjects were provided information in writing and verbally about the details of the study. Informed consent was obtained from all volunteers. Before the beginning of the study, all participants were subject to a medical examination in the Clinic for Dermatology and Dermatologic Allergology of the Friedrich Schiller University Jena. The AD was diagnosed according to the atopy-score of Diepgen. Severity of eczema was evaluated by using the SCORAD score. A skin prick test was performed for the exclusion of type 1 sensitivity to cow's milk.
The study was designed as a placebo-controlled and cross-over study. After a 3-week run-in period the 30 participants (15 healthy subjects and 15 patients with AD) were randomized to receive either 200 ml/d of a probiotic drink containing L. paracasei Lpc-37, L. acidophilus 74-2 and B. lactis 420 or 200 ml/d of a placebo drink for 8 weeks. After a 2-week washout period the intervention was crossed between the groups and the respective products were consumed for another 8 weeks followed by a 2-week washout period. Venous blood and fresh stool samples were collected before the beginning and at the end of each period. In AD patients the Scoring of atopic dermatitis (SCORAD) was assessed by the same physician every 4 weeks and 2 weeks after the wash-out period, respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
probiotics, atopic dermatitis, immune system, human, Lactobacillus, Bifidobacterium, healthy subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotics
Intervention Description
Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 Bifidobacterium animalis subsp. lactis DGCC 420
Primary Outcome Measure Information:
Title
SCORAD change in patients with AD taken at baseline and after 4 and 8 weeks, respectively -change in phagocytic and oxidative burst activity of monocytes and granulocytes at baseline and after 8 weeks
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
cellular and humoral immunological parameters (CD's; Interleukins); detection of bacterial species in faecs, faecal short-chain fatty acids, blood lipids
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects:
No allergic asthma
No allergic rhinoconjunctivitis
No food allergies
Exclusion of atopic diathesis (< 7 points in Erlangen atopy score)
Patients with AD:
Clear diagnosis of atopic dermatitis (> 10 points in the Erlangen atopy score) or flexural eczema or pruritis for at least 12 months (recidivating or permanent)
SCORAD 5-30 (minor or medium AD)
Willingness to apply for the duration of the study exclusively the cosmetic products recommended by the accompanying doctor and to use the recommended class II corticosteroid (Advantan) as further therapy of AD (for example during an episode)
Exclusion Criteria:
Pregnancy, lactation
Immune suppressive or cytostatic therapy or systemic steroids < 1 month before the first intake
Phototherapy or systemic therapy of AD < 1 month before the first intake
Active infections of the skin
Relevant asthma disease, which must be treated with inhalative corticoids (FEV1 < 70 %)
Patients with an indigestibility of/allergy against the components of milk/lactose intolerance (previously known or detected in the allergy test)
Patients under long-term treatment with systemic steroids, depot steroids, long-acting antihistamines, tranquilizers, psychopharmaceuticals
Intake of antihistamines, psychopharmaceuticals with antihistaminic effect and application of steroid containing cream to the forearms within the past 7 days before prick testing resp. treatment of the patient with Astemizol (Hismanal) within 4 weeks before the test. Such patients must be excluded from the study because of the long half-life of the medicament.
Acute or chronic symptomatic heart disease or severe internistic diseases
Autoimmune diseases, immune deficiencies (including immune suppressive treatment)
Immune-complex-induced immunopathies or malignant tumors
Abuse of alcohol, drugs or medicaments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Jahreis, Prof. Dr.
Organizational Affiliation
University of Jena, Dept. of Nutritional Physiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Jena, Institute of Nutrition, Department of Nutritional Physiology
City
Jena
State/Province
Thuringia
ZIP/Postal Code
07743
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
The Effect of a Probiotic Intervention in Healthy Subjects and Patients With Atopic Dermatitis
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