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Immune System Stimulation by Probiotic Food Supplementation

9. februar 2017 opdateret af: Hangzhou Wei Chuan Foods Co., Ltd.

Immune System Stimulation by Probiotic Food Supplementation: a Double-blind, Randomized, Controlled, Parallel-designed, Prospective Trial

The purpose of this study is to investigate the effects of a probiotic supplementation on adult volunteers with having caught the common cold more than 4 times in the past year. This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Subjects received a probiotic drink containing probiotics of Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacilluscasei431® (108CFU/ml) and Lactobacillus fermentiumPCC® (106CFU/ml) or an identical placebo without probiotics for a 12-week study period.

The incidence of flue and cold during the study period were compared between study groups.

Blood and fecal samples were collected at baseline and at the end of the intervention. Fecal samples were collected for the secretory immunoglobulin A (sIgA) analysis. Blood sample was drawn for interferon γ (IFN-γ), interleukin 4 (IL-4), interleukin 10 (IL-10), immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) analysis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

136

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

25 år til 45 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • male or female between 25 to 45 years old;
  • having caught the common cold or flu at least 4 to 6 times in the past calendar year;
  • signed the informed consent forms before entering the study;
  • fully understood the risks and potential benefits in participating this study.

Exclusion Criteria:

  • were diagnosed with the decreased immunity caused by any diagnosed chronic illness;
  • having any gastrointestinal illness with medical treatment at the time of being enrolled;
  • having any diagnosed respiratory illness with similar symptoms as the common cold and flu;
  • currently taking any pain killer drug;
  • having received any vaccine for the upper respiratory infection within 6 months before enrollment;
  • having received any purgative drug or digestion related drug within 2 weeks before enrollment;
  • having taken any dairy product containing prebiotics and probiotics within 10 days before enrollment;
  • currently taking any preventive drug for upper respiratory infection;
  • having received any drug which has impact with the immune system such as antibiotics within 3 months before enrollment;
  • alcoholic or addicted to any drug;
  • pregnant or breastfeeding mothers;
  • having participated another clinical trial within 3 months before enrollment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Weiquan Yogurt with probiotics
Weiquan Yogurt with probiotics contained Lactobacillus paracasei (108 colony forming units (CFU)/ml), Lactobacillus casei 431® (108 CFU/ml) and Lactobacillus fermentum PCC® (106 CFU/ml)
Kosttilskud: Weiquan Yogurt with probiotics
150 ml daily consumption for a total of 12 weeks
Placebo komparator: Weiquan Yogurt without probiotics
Weiquan Yogurt devoid of probiotics, but otherwise similar to the experimental product.
Kosttilskud: Weiquan Yogurt without probiotics
150 ml daily consumption for a total of 12 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of flue symptoms during the study
Tidsramme: end of week 12
Body temperature≥38.0℃, and have one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite.
end of week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of cold symptoms during the study
Tidsramme: end of week 12
Body temperature<38.0℃, and have one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite.
end of week 12
Number of accumulated days of having cold symptoms during the study
Tidsramme: End of week 12
The total number of days of having one or more symptoms of cough, runny nose, throat pain, headache, muscle pain, weak feeling, hard to breath, chest pain or loss of appetite during the 12 week study period.
End of week 12
Serum IFN-γ concentration
Tidsramme: Baseline, end of week 12
Interferon gamma (unit: pg/ml)
Baseline, end of week 12
Serum IL-4 concentration
Tidsramme: Baseline, end of week 12
Interleukin 4 (unit: ng/ml)
Baseline, end of week 12
Serum IL-10 concentration
Tidsramme: Baseline, end of week 12
Interleukin 10 (unit: pg/ml)
Baseline, end of week 12
Serum IgA concentration
Tidsramme: Baseline, end of week 12
Immunoglobulin A (unit: g/L)
Baseline, end of week 12
Serum IgG concentration
Tidsramme: Baseline, end of week 12
Immunoglobulin G (unit: g/L)
Baseline, end of week 12
Serum IgM concentration
Tidsramme: Baseline, end of week 12
Immunoglobulin M (unit: g/L)
Baseline, end of week 12
Fecal sIgA concentration
Tidsramme: Baseline, end of week 12
Secretory Immunoglobulin A (unit: ng/ml)
Baseline, end of week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hangzhou Wei Chuan Foods Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. januar 2016

Primær færdiggørelse (Faktiske)

10. april 2016

Studieafslutning (Faktiske)

2. maj 2016

Datoer for studieregistrering

Først indsendt

8. februar 2017

Først indsendt, der opfyldte QC-kriterier

9. februar 2017

Først opslået (Faktiske)

10. februar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 15-SC-09-WQ-002

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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