Celiac DiseaseNCT03064997
Prebiotic as a Supplement of Gluten-free Diet in the Management of Celiac Disease in Children
A study testing Synergy 1 in people with Celiac Disease, run by Polish Academy of Sciences at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Synergy 1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 2 sitesPoland
- Study dates
- 12 Jan 2016to 1 Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- celiac disease
- treatment with gluten-free diet for at least 6 months
- general good health
- the written informed consent to participate the study
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Regional Specialized Children'S Hospital
Olsztyn, 10-561
Institute of Animal Reproduction and Food Research, Polish Academy of Sciences in Olsztyn
Olsztyn, 10-748
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Celiac Disease
- Being tested
- Synergy 1, Placebo
- Keywords
- prebiotic, pediatric patients, health status, intestine permeability
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDietary supplement
a daily dose: 7 g/day of placebo (maltodextrin) consumed for 12 weeks together with a strict gluten-free diet
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic Synergy 1-supplemented GFD | Active comparator | The application of a prebiotic Synergy 1 together with a strict gluten-free diet Receives: Dietary Supplement: Synergy 1 |
| Placebo-supplemented GFD | Placebo comparator | The application of a placebo together with a strict gluten-free diet Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Assessment of the advers events
A number of participants with adverse events related to the treatment will be recorded
Measured: 6 months
Analysis of the concentration of the short chain fatty acids (SCFAs)
Changes in the concentration and a profile of the short chain fatty acids (SCFAs) using gas chromatography
Measured: 6 month
Molecular characteristic of faecal microbiota
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start12 Jan 2016
- Primary completion1 Mar 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polish Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warmia and Mazury
- Responsible party
- Principal investigator, Urszula Krupa-Kozak, Polish Academy of Sciences
- Investigators
- Urszula Krupa-Kozak, Ph.D, Principal investigator, Institute of Animal Reproduction and Food Reseach, Polish Academy of Sciences in OlsztynElżbieta Jarocka-Cyrta, MD, Ph.D, Principal investigator, Department of Clinical Pediatrics, Faculty of Medical Sciences, University of Warmia and Mazury
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064997
- Sponsor's protocol ID
- IAR&FR internal project 20
- Status last verified
- Oct 2019
- First submitted
- 16 Feb 2017
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30959740Drabinska 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.
PubMed 30840918Ferus 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.
PubMed 30469412Drabinska 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.
PubMed 30445682Drabinska 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.
PubMed 30043079Drabinska 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.
PubMed 29439526Krupa-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.
PubMed 28830428
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03064997
- Acronym / sponsor ID
- IAR&FR internal project 20
- Conditions
- Celiac Disease
- Keywords
- prebiotic, pediatric patients, health status, intestine permeability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Polish Academy of SciencesUniversity, hospital or other
- Collaborators
- University of Warmia and Mazury
- Study start
- 12 Jan 2016 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prebiotic Synergy 1-supplemented GFD | Active comparator | Dietary Supplement: Synergy 1The application of a prebiotic Synergy 1 together with a strict gluten-free diet |
| Placebo-supplemented GFD | Placebo comparator | Dietary Supplement: PlaceboThe application of a placebo together with a strict gluten-free diet |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- celiac disease
- treatment with gluten-free diet for at least 6 months
- general good health
- the written informed consent to participate the study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synergy 1a daily dose: 7 g/day of Synergy1 (oligofructose enriched inulin) consumed for 12 weeks together with a strict gluten-free diet | Dietary supplement | Prebiotic Synergy 1-supplemented GFD |
| Placeboa daily dose: 7 g/day of placebo (maltodextrin) consumed for 12 weeks together with a strict gluten-free diet | Dietary supplement | Placebo-supplemented GFD |
Primary outcome
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
3 secondary outcomes
Assessment of the advers events
Time frame: 6 months
Analysis of the concentration of the short chain fatty acids (SCFAs)
Time frame: 6 month
Molecular characteristic of faecal microbiota
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Results publication: PubMed 30959740Drabinska 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.
- Results publication: PubMed 30840918Drabinska 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.
- Results publication: PubMed 30469412Ferus 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.
- Results publication: PubMed 30445682Drabinska 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.
- Results publication: PubMed 30043079Drabinska 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.
- Results publication: PubMed 29439526Drabinska 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.
- Derived from this study: PubMed 28830428Krupa-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urszula Krupa-Kozak, Ph.D principal investigator
Institute of Animal Reproduction and Food Reseach, Polish Academy of Sciences in Olsztyn
Elżbieta Jarocka-Cyrta, MD, Ph.D principal investigator
Department of Clinical Pediatrics, Faculty of Medical Sciences, University of Warmia and Mazury
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synergy 1 in people with Celiac Disease, run by Polish Academy of Sciences at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the intestinal permeability (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03064997, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.