Trial reportNutrition journal2017
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.
Trial report in Nutrition journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03064997 (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), which is not on this map. Cited by 21 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
21 citing papers in PubMed.
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- 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 (Basel, Switzerland) · 2019Trial
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- From gluten to therapeutics: molecular mechanisms of celiac disease and emerging alternatives to the gluten-free diet.Frontiers in pharmacology · 2026Review
- Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments.Nutrients · 2025Review
- New Therapeutic Challenges in Pediatric Gastroenterology: A Narrative Review.Healthcare (Basel, Switzerland) · 2025Review
- Nutraceuticals and biotics in pediatric gastrointestinal disorders.European journal of clinical nutrition · 2024Review
- Influence of dietary and lifestyle factors on levels of inflammatory markers (IL-6, IFN-γ and TNF-α) in obese subjects.Central-European journal of immunology · 2024Article
- The Role of Intestinal Microbiota in Celiac Disease and Further Therapeutic Perspectives.Life (Basel, Switzerland) · 2023Review
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- Article
- How Metabolomics Provides Novel Insights on Celiac Disease and Gluten-Free Diet: A Narrative Review.Frontiers in microbiology · 2022Review
- Delivery mode-associated gut microbiota in the first 3 months of life in a country with high obesity rates: A descriptive study.Medicine · 2020Observational
- Probiotics, Prebiotics and Other Dietary Supplements for Gut Microbiota Modulation in Celiac Disease Patients.Nutrients · 2020Review
- Associations of Mediterranean Diet and a Posteriori Derived Dietary Patterns with Breast and Lung Cancer Risk: A Case-Control Study.Nutrients · 2018Article
- A Longitudinal Observational Study of a Powder-Based Supplement for a Future Synbiotic Trial in Breastfed Children From South Africa.Sage open pediatricsArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA lifelong gluten-free diet (GFD) is regarded as the only proven and accepted therapy for coeliac disease (CD). However, even patients who strictly follow a GFD often suffer from intestinal symptoms and malabsorption. Selective modulation of intestinal microbiota with prebiotics could remedy various symptoms associated with CD. The use of prebiotics in the treatment of intestinal diseases remains insufficiently investigated. To our knowledge, this study makes the first attempt to evaluate the effect of prebiotic supplementation on gastrointestinal symptoms and nutritional status of children with CD. We hypothesized that adherence to a GFD supplemented with oligofructose-enriched inulin (Synergy 1) would deliver health benefits to children suffering from CD without any side effects, and that it would alleviate intestinal inflammation, restore and stabilize gut microbial balance and reverse nutritional deficiencies through enhanced absorption of vitamins and minerals.
methodsA randomized, placebo-controlled clinical trial was designed to assess the impact of the Synergy 1 on paediatric CD patients following a GFD. We randomized 34 children diagnosed with CD into an intervention group receiving 10 g of the Synergy 1 supplement daily and a placebo group (receiving maltodextrin) during a 12-week nutritional intervention. Selected biochemical parameters, nutritional status and the characteristics of faecal bacteria will be determined in samples collected before and after the intervention. Analysis of vitamins and amino acids concentration in biological fluids will allow to assess the dietary intake of crucial nutrients. The compliance to a GFD will be confirmed by a Food Frequency Questionnaire (FFQ-6) and the analysis of serum anti-tissue transglutaminase and faecal gluten immunogenic peptides (GIP).
conclusionThe identification of the beneficial effects of the Synergy 1 supplement on children with CD could have important implications for nutritional recommendations for CD patients and for alleviating the harmful effects of the disease.
trial registrationClinicalTrials.gov Registration Number: NCT03064997 .
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