NCT00550472

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2007

Completed
Last Updated

April 15, 2008

Status Verified

April 1, 2008

Enrollment Period

7 months

First QC Date

October 25, 2007

Last Update Submit

April 10, 2008

Conditions

Atopic Dermatitis

Keywords

probioticsatopic dermatitisimmune systemhumanLactobacillusBifidobacteriumhealthy subjects

Outcome Measures

Primary Outcomes (1)

  • 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

    8 weeks

Secondary Outcomes (1)

  • cellular and humoral immunological parameters (CD's; Interleukins); detection of bacterial species in faecs, faecal short-chain fatty acids, blood lipids

    8 weeks

Study Arms (1)

Probiotic

EXPERIMENTAL

intervention

Dietary Supplement: probiotics

Interventions

probioticsDIETARY_SUPPLEMENT

Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus 74-2 Bifidobacterium animalis subsp. lactis DGCC 420

Probiotic

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects:
  • No allergic asthma
  • No allergic rhinoconjunctivitis
  • No food allergies
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jena, Institute of Nutrition, Department of Nutritional Physiology

Jena, Thuringia, 07743, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Gerhard Jahreis, Prof. Dr.

    University of Jena, Dept. of Nutritional Physiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2007

First Posted

October 29, 2007

Study Start

December 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

April 15, 2008

Record last verified: 2008-04

Locations

DE(1)