Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03997175
Other study ID # HelsinkiUIG1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 15, 2018
Est. completion date July 30, 2018

Study information

Verified date June 2019
Source Helsinki University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Children were exposed to biodiverse material or non-diverse material in sand pits. The two arms were compared. Immune response and bacterial markers were followed.


Description:

Children of age 3-5 were randomly divided into two groups (arms). One received guidance and biodiverse material for 20 minutes each day for two weeks. The other received the a similar material and guidance but the microbial community in the material was poor in diversity. Bacterial community changes and immune system markers were analyzed and compared between the two arms. Potential changes in Interleukin 10 was the primary outcome.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date July 30, 2018
Est. primary completion date July 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria:

- healthy

- born in Finland

- spends daily (5 d a week) several hours in one of the daycares in which the trial was performed

Exclusion Criteria:

- medication affecting immune system function

- medication affecting microbiota

- cancer

- immune deficiency

- living on a farm

- not born in Finland

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Biodiversity powder
Biodiversity sand contained biodiversity powder that contains a highly diverse and rich microbial community but no known pathogens.
Placebo
Sand that looks like intervention sand but does not have high biodiversity

Locations

Country Name City State
Finland Helsinki University Lahti Häme

Sponsors (2)

Lead Sponsor Collaborator
Helsinki University Tampere University

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Interleukin 10 level in blood The difference between day 0 and a follow up day in intervention two weeks
Secondary changes in microbiota all potential changes in bacterial profile are measured on skin and stool samples two weeks
Secondary changes in interleukin 17 levels all measured changes in interleukin 17 levels two weeks
Secondary changes in tgf-beta levels change in tgf-beta levels two weeks
Secondary ratio il-10 / il-17 potential changes in the ratio of these two citokines two weeks
Secondary long-term changes in microbiota potential changes that last for four weeks four weeks
See also
  Status Clinical Trial Phase
Recruiting NCT03663933 - Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation Phase 2
Completed NCT03563066 - Effect of Benralizumab in Atopic Dermatitis Phase 2
Recruiting NCT04339777 - Allogeneic Hematopoietic Stem Cell Transplant for Patients With Inborn Errors of Immunity Phase 2
Not yet recruiting NCT05969821 - Clonal Hematopoiesis of Immunological Significance
Completed NCT02916888 - A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists N/A
Completed NCT02527187 - Determination of the Sensitivity and Specificity of Prick Test Betula Verrucosa Phase 2
Completed NCT01441076 - Anakinra for Behcet s Disease Phase 1/Phase 2
Completed NCT01472263 - Use of Pentoxifylline in Human T-lymphotropic Virus Type-1 (HTLV-1) Diseases Phase 3
Completed NCT03720470 - Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy Phase 3
Suspended NCT04642066 - Cold Water Immersion and Atherosclerosis, Inflammation, Fat Accumulation and Lipid Profile Parameters N/A
Completed NCT02294552 - Post-transplantation Cyclophosphamide as GVHD Prophylaxis After HSCT Phase 2
Completed NCT01727973 - Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy Phase 1/Phase 2
Completed NCT04103099 - Impact of HLNatural Immune Supplement on Colds N/A
Recruiting NCT03344094 - Mechanism of Action of Ocrelizumab in Multiple Sclerosis N/A
Active, not recruiting NCT05445284 - Group Education Trial to Improve Transition for Parents of Adolescents With T1D N/A
Recruiting NCT06104111 - Epigenetic Memory of Vitamin D Supplementation Phase 1
Not yet recruiting NCT05616117 - Next-generation Effects of Vitamin D Supplementation in Pregnancy
Completed NCT01490177 - Single Center Food Allergy Oral Immunotherapy Study Phase 1
Completed NCT01510626 - Omalizumab With Oral Food Immunotherapy With Food Allergies Open Label Safety Study in a Single Center Phase 1
Completed NCT03922087 - No-worry Baby Project