- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01020617
The Effect of Probiotics on Low-grade Inflammation, Microbiota and Risk Factors for Metabolic Syndrome in Obese Children
Association Between the Diet, the Composition of Microbiota of the Intestinal Tract, Human Health and Well-being
Metabolic syndrome and thereby obesity is associated with low-grade systemic inflammation and it is likely that this is also the case in children (Ley et al., 2005). It has also been shown that the gut microbiota is different in obese individuals compared to normal weight individuals and that the microbiota seems to have a role in fat storage (Backhead et al, 2004).
Intervention study with overweight and normal weight school age children. The children will be randomised to receive selected probiotics or a placebo. Fecal and blood samples will be collected, and anthropometric measurements (weight, height, skin folds) will be recorded before and after the intervention. The dynamic of the microbiota of the GI will be monitored by molecular methods. Markers of intestinal inflammation (calprotectin) and permeability will be analysed. Blood samples will be analysed to evaluate how the intervention influence the systemic polarization of the immune response by means of cytokine analyses. Furthermore, blood pressure, blood lipid profile and early markers of metabolic syndrome will be evaluated. Hypotheses This study will examine if overweight in children is associated with a different intestinal microbiota and if a change in microbiota caused by probiotics can modify inflammation and risk factors for the metabolic syndrome.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
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Frederiksberg, Danmark, 1958
- Copenhagen University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 12-15 years
- IsoBMI>30
Exclusion Criteria:
- Chronical diseases
- Chronical medication
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Microbiota diversity
Tidsramme: one year
|
one year
|
|
Inflammation, CRP
Tidsramme: 2 months
|
high sensitive C-reactive protein
|
2 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Antropometry
Tidsramme: one year
|
one year
|
Blodtryk
Tidsramme: et år
|
et år
|
Blood lipids
Tidsramme: one year
|
one year
|
Fasting insulin
Tidsramme: one year
|
one year
|
Fasting glucose
Tidsramme: one year
|
one year
|
C-reactive protein (CRP)
Tidsramme: 6 months
|
6 months
|
Fecal calprotectin
Tidsramme: 7 months
|
7 months
|
Interleukin-6 (Il-6)
Tidsramme: one year
|
one year
|
Interleukin-10 (IL-10)
Tidsramme: one year
|
one year
|
Tumor necrosis factor-alpha(TNF-α)
Tidsramme: one year
|
one year
|
Adiponectin
Tidsramme: one year
|
one year
|
Leptin
Tidsramme: one year
|
one year
|
GIP
Tidsramme: one year
|
one year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Kim F Michaelsen, Professor, University of Copenhagen, Department of Human Nutrition
Publikationer og nyttige links
Generelle publikationer
- Larsen N, Vogensen FK, Gobel RJ, Michaelsen KF, Forssten SD, Lahtinen SJ, Jakobsen M. Effect of Lactobacillus salivarius Ls-33 on fecal microbiota in obese adolescents. Clin Nutr. 2013 Dec;32(6):935-40. doi: 10.1016/j.clnu.2013.02.007. Epub 2013 Mar 4.
- Giacco R, Lappi J, Costabile G, Kolehmainen M, Schwab U, Landberg R, Uusitupa M, Poutanen K, Pacini G, Rivellese AA, Riccardi G, Mykkanen H. Effects of rye and whole wheat versus refined cereal foods on metabolic risk factors: a randomised controlled two-centre intervention study. Clin Nutr. 2013 Dec;32(6):941-9. doi: 10.1016/j.clnu.2013.01.016. Epub 2013 Feb 6.
- Gobel RJ, Larsen N, Jakobsen M, Molgaard C, Michaelsen KF. Probiotics to adolescents with obesity: effects on inflammation and metabolic syndrome. J Pediatr Gastroenterol Nutr. 2012 Dec;55(6):673-8. doi: 10.1097/MPG.0b013e318263066c.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D206 ProTeen
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Kliniske forsøg med Betændelse
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-
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-
Paraskevi MatsotaAfsluttet
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Assistance Publique - Hôpitaux de ParisAfsluttetSystemisk inflammation | BiomarkørFrankrig
-
Harokopio UniversityUkendtBlodpladeaggregation og inflammationGrækenland
-
University of EdinburghUmeå UniversityAfsluttet
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University of AarhusAarhus University Hospital; University of CopenhagenAfsluttetSystemisk inflammation | LuftvejsbetændelseDanmark
Kliniske forsøg med Ls-33
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Benha UniversityAfsluttet
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Rockefeller UniversityAfsluttet
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National Institute of Allergy and Infectious Diseases...Rockefeller UniversityTrukket tilbageHIV-infektionerForenede Stater
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The Affiliated Hospital of the Chinese Academy...Chinese PLA General HospitalUkendtRecidiverende og/eller refraktær CD33+ AMLKina
-
Imperial College Healthcare NHS TrustImperial College London; University of Oxford; Oxford University Hospitals...Trukket tilbageLymfom | Leukæmi | Immun trombocytopeni | SARS-CoV2-infektion | SARS-CoV-2 akut luftvejssygdom | Myelom | Trombotisk trombocytopenisk purpura (TTP)Det Forenede Kongerige
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Hoffmann-La RocheAfsluttet