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Trial record 40 of 226 for:    Intestinal | maltodextrin

Prebiotic Fructans on the Incidence of Acute Infectious Diseases in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03241355
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Beneo-Institute

Brief Summary:
The study aims to explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children during a winter period.

Condition or disease Intervention/treatment Phase
Infectious Disease Children, Only Diet Modification Dietary Supplement: prebiotic inulin-type fructan Dietary Supplement: Placebo maltodextrin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double-blind, Parallel, Randomized, (Placebo-controlled) Explorative Study on the Effect of a Mixture of Prebiotic Oligosaccharides on the Composition of Intestinal Microbiota and Selected Health Outcomes in Children 3 to 6 Years of Age
Actual Study Start Date : September 16, 2013
Actual Primary Completion Date : April 28, 2014
Actual Study Completion Date : April 28, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Inulin

Arm Intervention/treatment
Active Comparator: prebiotic inulin-type fructan Dietary Supplement: prebiotic inulin-type fructan
Placebo Comparator: placebo maltodextrin Dietary Supplement: Placebo maltodextrin



Primary Outcome Measures :
  1. Frequency of infectious disease episodes [ Time Frame: 24 weeks period ]

Secondary Outcome Measures :
  1. microbiota composition [ Time Frame: 24 weeks period ]
    fecal microbiota composition (qPCR, illumina)



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is healthy at the time of pre-examination
  • Subject is aged 3-6 years at the time of pre-examination
  • Subject attends a kindergarten at the time of pre-examination

Exclusion Criteria:

  • congenital disease or malformation influencing the gastrointestinal System
  • children with congenital or acquired immunodeficiency
  • children with food intolerance, food allergy or metabolic disorder requiring special diet
  • children who regularly (more than 3 times per week) consumed products or food supplements containing prebiotics or probiotics
  • children who consumed antibiotics or laxatives within 14 days
  • children who had any infectious disease within 14 days at the time of pre-examination

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): NCT03241355


Sponsors and Collaborators
Beneo-Institute
Investigators
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Principal Investigator: Tamás Decsi, Prof. Department of Paediatrics, University of Pécs, Hungary

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Beneo-Institute
ClinicalTrials.gov Identifier: NCT03241355     History of Changes
Other Study ID Numbers: 13004n_Fructan_Study
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Levan
Antineoplastic Agents