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Completed

NCT Number: NCT03064997

Prebiotic as a Supplement of Gluten-free Diet in the Management of Celiac Disease in Children

Prebiotics are known as substances affecting beneficially the organism by restoring the intestinal microbiota balance, stabilizing the intestinal barrier and modulating the endocrine and immune functions. In many persons suffering from celiac disease (CD), despite a gluten-free diet (GFD), an impaired intestinal barrier functionality, accompanied by altered intestinal microbiota and ongoing intestinal inflammation is observed. For these reasons, prebiotic could be a promising and low-risk adjuvant in the dietetic management of CD. It was hypothesize that prebiotic preparation Synergy 1 consumed by CD children as a supplement of a GFD will affect beneficial the intestinal permeability and intestinal microbiota without side effects.

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Key information

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Animal Reproduction and Food Research, Polish Academy of Sciences in Olsztyn, Olsztyn, Poland

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About this study

Prebiotics, including inulin-type fructans (ITFs) are a group of the naturally occurring plant carbohydrates stored in various amounts in tubers, bulbs and tuberous roots of several edible fruits and vegetables and in particularly large amounts in the tubers of Helianthus tuberosus (Jerusalem artichoke) and Cichorium intybus (chicory). Because of their unique structural properties, they are not hydrolyzed by the enzymes of the upper intestinal digestive tract and reach the colon unchanged, therefore are classified as prebiotics. Prebiotics are defined as selectively fermented ingredients that allow specific changes in the composition and/or balance of the microbiota. ITFs, particularly the mixture of short- and long-chain polymers, indicate several beneficial effects, including the positive changes in the histological picture of the intestine (proliferation in the crypts and Goblet cells, longer intestinal villi) and modulation of the endocrine and immune functions. Moreover, they have a great potential as agents improving or maintaining a balanced intestinal microbiota both in the lumen and at the mucosal surface, to one in which bifidobacteria and lactobacilli come to greater prominence. This, so-called healthier flora, should provide increased resistance to gut infections and may also have immuno-modulatory properties. Until now, inulin and fructooligosaccharide (FOS) have been tested mainly in animal models of inflammatory bowel diseases (IBD). Reports on animal colitis model suggests that prebiotics have the anti-inflammatory properties as they reduce the inflammation symptoms, along with the increase in bifidobacteria or lactobacilli number, and in some reports, the increase in the concentration of butyrate in the gut.

Prebiotics are known as substances affecting beneficially the organism by restoring the intestinal microbiota balance, stabilizing the intestinal barrier and modulating the endocrine and immune functions. In many persons suffering from celiac disease (CD), despite a gluten-free diet (GFD), an impaired intestinal barrier functionality, accompanied by altered intestinal microbiota and ongoing intestinal inflammation is observed. For these reasons, prebiotics could be a promising and low-risk adjuvant in the dietetic management of CD. It was hypothesized that Synergy 1 consumed by CD children as a supplement of a GFD will affect beneficial the intestinal permeability and intestinal microbiota without side effects. The primary objective of this randomized placebo-controlled study was to determine the effect of 3-months consumption of Synergy 1 versus placebo, as the supplements of a GFD, on the intestinal permeability in CD children, in particular on the concentration of the intestinal fatty acid binding protein (iFABP) as a biomarker of intestinal permeability. The secondary objective was to determine the effect of Synergy 1 versus placebo applied in GFD on the changes in the gut microbiota quantity and metabolism in CD children.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • celiac disease
  • treatment with gluten-free diet for at least 6 months
  • general good health
  • the written informed consent to participate the study

Exclusion criteria

  • participation in another study involving prebiotic and/or probiotic preparations, or intention to use such products during the course of the study
  • other gastrointestinal diseases
  • received antibiotics in the previous month
  • use of dietary supplements containing prebiotic or/and probiotic within the previous month
  • bad or average overall health

Treatment and study plan

Synergy 1

Dietary Supplement

a daily dose: 7 g/day of Synergy1 (oligofructose enriched inulin) consumed for 12 weeks together with a strict gluten-free diet

Placebo

Dietary Supplement

a daily dose: 7 g/day of placebo (maltodextrin) consumed for 12 weeks together with a strict gluten-free diet

Primary outcomes

  1. Assessment of the intestinal permeability

    Time frame: 6 months

    Changes in the concentration of intestinal fatty acid binding protein (iFABP) as a biomarker of intestinal permeability will be determined

Secondary outcomes

  1. Assessment of the advers events

    Time frame: 6 months

    A number of participants with adverse events related to the treatment will be recorded

  2. Analysis of the concentration of the short chain fatty acids (SCFAs)

    Time frame: 6 month

    Changes in the concentration and a profile of the short chain fatty acids (SCFAs) using gas chromatography

  3. Molecular characteristic of faecal microbiota

    Time frame: 6 month

    Quantitative characteristics of faecal bacteria will be conducted with the real-time polymerase chain reaction (RT-PCR) technique and group-specific primers. Population level of Bifidobacterium, Bacteroides, Clostridium coccoides, C. leptum and E. coli groups will be determined among others.

Sponsors and collaborators

Lead sponsor

Polish Academy of Sciences

Other

Collaborators

  • University of Warmia and Mazury

Registry information

Official study title

Assessment of the Impact of Prebiotic Synergy 1 on the Intestine Permeability, Clinical Symptoms, and Selected Biochemical and Nutritional Parameters in the Children With Celiac Disease on a Gluten-free Diet

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 27, 2017
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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