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Trial record 41 of 562 for:    maltodextrin

Assessment of Efficacy of the Consumption of a Heat-treated Lactobacillus Paracasei (GM080) on Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT02103972
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

Brief Summary:
The primary objective of this trial is to assess the efficacy of the consumption of heat-treated Lactobacillus paracasei (GM080) on atopic dermatitis as compared to a placebo treatment.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Dietary Supplement: GM080 Dietary Supplement: Maltodextrin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : July 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Placebo Comparator: Maltodextrin
Maltodextrin
Dietary Supplement: Maltodextrin
Active Comparator: GM080
GM080
Dietary Supplement: GM080



Primary Outcome Measures :
  1. Change from Baseline SCORAD Score at 16 weeks of treatment [ Time Frame: between 0 and 16 weeks of treatment ]
    SCORAD documented during the longitudinal observational period of 16 weeks after the subject has enrolled


Secondary Outcome Measures :
  1. Score A, B and C of the SCORAD [ Time Frame: 0, 4, 10 and 16 weeks of treatment ]
    Score A, B and C of the SCORAD The scores A, B and C of the SCORAD as well as the subcategories of the scores B and C will be analyzed separately (measured at V0c, V1, V2 and V3)

  2. Number and duration of atopic dermatitis episodes [ Time Frame: during the 16 weeks intervention period ]
    Number and duration of atopic dermatitis episodes The number of episodes of atopic dermatitis and the total number of days with symptoms during the 16 weeks intervention period

  3. Transepidermal water loss [ Time Frame: 0, 4, 10 and 16 weeks ]
    TEWL will be measured at V0, V1, V2 and V3 on 4 sites of both non-lesional and lesional appearing skin parts

  4. Topical treatment used [ Time Frame: during the 16 weeks of treatment ]
    Topical treatment used (sparing effect) The corticoid sparing effect of the ingredient will be assessed in the placebo and the ingredient group.

  5. total and specific IgE [ Time Frame: 0 and 16 weeks ]
    total and specific IgE

  6. Quality of Life [ Time Frame: 0, 4, 10, 16 weeks and 1 and 4 years later ]
    The infants' dermatitis quality of life index (IDQOL) will be collected

  7. assess the effect of the product on the safety parameters [ Time Frame: 0 and 16 weeks ]
    Biochemistry and Hematology parameters

  8. "Objective" SCORAD, which is composed of part A and B of the SCORAD (measured at V0, V1, V2 and V3) [ Time Frame: 0, 4, 10 and 16 weeks ]

Other Outcome Measures:
  1. Diaper rash episodes and duration will be recorded by the parents/caregivers [ Time Frame: duting the 16 weeks of treatment ]
    Diaper rash episodes and duration will be recorded by the parents/caregivers

  2. Perception/impression of the ingredient by the caregiver [ Time Frame: at 16 weeks ]
    At the end of the 16 weeks intervention trial, the perception of the caregivers toward the ingredient they were randomized to, will be assessed

  3. Assessment of allergic history and skin disease [ Time Frame: 1 and 4 years later ]
  4. Cytokine quantification [ Time Frame: 0 and 16 weeks of treatment ]
    Cytokine quantification (multiplex) will be assessed in plasma of the patients

  5. Genetic characterization of atopic dermatitis associated polymorphism [ Time Frame: 0 week ]
    Five major mutations in the FLG gene, one polymorphism in SPINK5 and one insertion in KLK7 gene will be analyzed in blood DNA



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Ages Eligible for Study:   4 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants aged from 4-30 months (inclusive) at the time of enrolment (63 in each group).
  • With mild to severe atopic symptoms: SCORAD ≥ 20 (at V0b).
  • Having obtained his/her (or his/her legal representative's) written Informed Consent.

Exclusion Criteria:

  • SCORAD inferior to 20 (SCORAD less than 20 at V0b). A SCORAD less than 20 at V0c is not an exclusion criteria.
  • Infants who need a systemic treatment for their skin condition (e.g. glucocorticoids, steroids, cyclosporine A).
  • Infants or mothers who introduce probiotics (other than the study product) in their diet during the 16-weeks intervention study. Of note: Infants or mothers who are used to consume a certain probiotic for more than 1 month before the start of the study (V0b), can continue to use this probiotic during the intervention period and will not be excluded. Recent introduction of probiotics, within a month before the planned start of the study (V0b) should be stopped and recorded; at least 1 month should be between stopping the consumption of the probiotic and V0b).
  • Infants having other inflammatory skin diseases (urticaria, psoriasis).
  • Infants having a congenital illness or malformation that may affect normal growth (especially immunodeficiency).
  • Infants whose parents/caregivers cannot be expected to comply with the study procedures.
  • Infants currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.
  • Infants using topical calcineurin inhibitors (e.g. tacrolimus and pimecrolimus (ELIDEL®)) during the study.
  • Infants who have undergone in the month before the start of the study (V0b), are currently undergoing or are anticipated to undergo ultraviolet light therapy or wet dressing or any other topical treatment of their eczema other than the one provided in the study. Lotion and skin moisturizer are allowed but need to be monitored for frequency and area.
  • The investigator and clinician will assess if the child has to be excluded based on the patient's medical condition and taken into account the values of the safety parameters tested. Therefore, no cut-off values, or normal ranges for the different safety parameters are exclusion criteria. It will be the responsibility of the investigator and clinician, based on their medical judgement, to decide if it is safe or not to include an infant into the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103972


Locations
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Taiwan
Kaohsiung Municipal TA-TUNG Hospital
Kaohsiung City, Qianjin District, Taiwan, 801
Kaohsiung Municipal Hsiao-Kang Hospital
Kaohsiung City, Siaogang District, Taiwan, 812
Taipei Chang Gung Memorial Hospital of the Chang-Gung Medical foundation
Taipei City, Songshan District, Taiwan, 105
Chung Shan Medical University Hospital
Taichung City, South District, Taiwan, 402
Linkou Chang Gung Memorial Hospital
Gueishan Township, Taoyuan County, Taiwan, 333
Cardinal Tien Hospital
New Taipei City, Xindian District, Taiwan, 231
Sponsors and Collaborators
Nestlé

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02103972     History of Changes
Other Study ID Numbers: 11.46.NRC
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Keywords provided by Nestlé:
All subjects of any ethnicity aged from 4 to 30 months with atopic dermatitis skin symptoms with a SCORAD equal or above 20
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases