NCT03064997

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 27, 2017

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

2 months

First QC Date

February 16, 2017

Last Update Submit

October 25, 2019

Conditions

Celiac Disease

Keywords

prebioticpediatric patientshealth statusintestine permeability

Outcome Measures

Primary Outcomes (1)

  • Assessment of the intestinal permeability

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

    6 months

Secondary Outcomes (3)

  • Assessment of the advers events

    6 months

  • Analysis of the concentration of the short chain fatty acids (SCFAs)

    6 month

  • Molecular characteristic of faecal microbiota

    6 month

Study Arms (2)

Prebiotic Synergy 1-supplemented GFD

ACTIVE COMPARATOR

The application of a prebiotic Synergy 1 together with a strict gluten-free diet

Dietary Supplement: Synergy 1

Placebo-supplemented GFD

PLACEBO COMPARATOR

The application of a placebo together with a strict gluten-free diet

Dietary Supplement: Placebo

Interventions

Synergy 1DIETARY_SUPPLEMENT

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

Prebiotic Synergy 1-supplemented GFD
PlaceboDIETARY_SUPPLEMENT

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

Placebo-supplemented GFD

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Regional Specialized Children'S Hospital

Olsztyn, 10-561, Poland

Location

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

Olsztyn, 10-748, Poland

Location

Related Publications (7)

  • Drabinska N, Jarocka-Cyrta E, Ratcliffe NM, Krupa-Kozak U. The Profile of Urinary Headspace Volatile Organic Compounds After 12-Week Intake of Oligofructose-Enriched Inulin by Children and Adolescents with Celiac Disease on a Gluten-Free Diet: Results of a Pilot, Randomized, Placebo-Controlled Clinical Trial. Molecules. 2019 Apr 5;24(7):1341. doi: 10.3390/molecules24071341.

    PMID: 30959740RESULT

  • Drabinska N, Jarocka-Cyrta E, Zlotkowska D, Abramowicz P, Krupa-Kozak U. Daily oligofructose-enriched inulin intake impacts bone turnover markers but not the cytokine profile in pediatric patients with celiac disease on a gluten-free diet: Results of a randomised, placebo-controlled pilot study. Bone. 2019 May;122:184-192. doi: 10.1016/j.bone.2019.03.001. Epub 2019 Mar 3.

    PMID: 30840918RESULT

  • Ferus K, Drabinska N, Krupa-Kozak U, Jarocka-Cyrta E. A Randomized, Placebo-Controlled, Pilot Clinical Trial to Evaluate the Effect of Supplementation with Prebiotic Synergy 1 on Iron Homeostasis in Children and Adolescents with Celiac Disease Treated with a Gluten-Free Diet. Nutrients. 2018 Nov 21;10(11):1818. doi: 10.3390/nu10111818.

    PMID: 30469412RESULT

  • Drabinska N, Krupa-Kozak U, Abramowicz P, Jarocka-Cyrta E. Beneficial Effect of Oligofructose-Enriched Inulin on Vitamin D and E Status in Children with Celiac Disease on a Long-Term Gluten-Free Diet: A Preliminary Randomized, Placebo-Controlled Nutritional Intervention Study. Nutrients. 2018 Nov 15;10(11):1768. doi: 10.3390/nu10111768.

    PMID: 30445682RESULT

  • Drabinska N, Krupa-Kozak U, Ciska E, Jarocka-Cyrta E. Plasma profile and urine excretion of amino acids in children with celiac disease on gluten-free diet after oligofructose-enriched inulin intervention: results of a randomised placebo-controlled pilot study. Amino Acids. 2018 Oct;50(10):1451-1460. doi: 10.1007/s00726-018-2622-7. Epub 2018 Jul 24.

    PMID: 30043079RESULT

  • Drabinska N, Jarocka-Cyrta E, Markiewicz LH, Krupa-Kozak U. The Effect of Oligofructose-Enriched Inulin on Faecal Bacterial Counts and Microbiota-Associated Characteristics in Celiac Disease Children Following a Gluten-Free Diet: Results of a Randomized, Placebo-Controlled Trial. Nutrients. 2018 Feb 12;10(2):201. doi: 10.3390/nu10020201.

    PMID: 29439526RESULT

  • Krupa-Kozak U, Drabinska N, Jarocka-Cyrta E. The effect of oligofructose-enriched inulin supplementation on gut microbiota, nutritional status and gastrointestinal symptoms in paediatric coeliac disease patients on a gluten-free diet: study protocol for a pilot randomized controlled trial. Nutr J. 2017 Aug 22;16(1):47. doi: 10.1186/s12937-017-0268-z.

    PMID: 28830428DERIVED

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Urszula Krupa-Kozak, Ph.D

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

    PRINCIPAL INVESTIGATOR

  • Elżbieta Jarocka-Cyrta, MD, Ph.D

    Department of Clinical Pediatrics, Faculty of Medical Sciences, University of Warmia and Mazury

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D.

Study Record Dates

First Submitted

February 16, 2017

First Posted

February 27, 2017

Study Start

January 12, 2016

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

October 29, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

PL(2)