Trial reportTrials2016
Effect of prebiotic intake on gut microbiota, intestinal permeability and glycemic control in children with type 1 diabetes: study protocol for a randomized controlled trial.
Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02442544 (Effect of Prebiotic Fiber on Gut Microbiota, Intestinal Permeability and Glycemic Control in Children With Type 1 Diabetes), which is not on this map. Cited by 25 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Effect of Prebiotic Fiber on Gut Microbiota, Intestinal Permeability and Glycemic Control in Children With Type 1 Diabetes: A Pilot Randomized, Double Blind, Placebo Controlled Study
Who cites it
25 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.
- Pooled it
- Can probiotic, prebiotic, and synbiotic supplementation modulate the gut-liver axis in type 2 diabetes? A narrative and systematic review of clinical trials.Frontiers in nutrition · 2022Pooled it
- Adjuvant Probiotics ofFrontiers in endocrinology · 2022Trial
- Trial
- The Role of Microbiota in Type 1 Diabetes: Insights into Dysbiosis and Immune Interactions.Nutrients · 2026Review
- The Gut-Pancreas Axis in Type 1 Diabetes: Emerging Insights into Microbiota and Immune Interactions.International journal of molecular sciences · 2026Review
- Inulin as a Modulator of the Intestinal Barrier: Experimental Evidence, Mechanisms and Clinical Implications.Biomedicines · 2026Review
- Pre-Type 1 Diabetes in Adolescents and Teens: Screening, Nutritional Interventions, Beta-Cell Preservation, and Psychosocial Impacts.Journal of clinical medicine · 2025Review
- Assessment of selected muscle damage markers and zonulin concentration after maximum-intensity exercise in men with type 1 diabetes treated with a personal insulin pump.Acta diabetologica · 2023Article
- Fermentation Supernatant of Elderly Feces with Inulin and Partially Hydrolyzed Guar Gum Maintains the Barrier of Inflammation-Induced Caco-2/HT29-MTX-E12 Co-Cultured Cells.Journal of agricultural and food chemistry · 2023Article
- The role and mechanism of the gut microbiota in the development and treatment of diabetic kidney disease.Frontiers in physiology · 2023Review
- Gut Microbiome as Potential Therapeutics in Multiple Sclerosis.Current treatment options in neurology · 2021Article
- Holistic perspective of the role of gut microbes in diabetes mellitus and its management.World journal of diabetes · 2021Review
- What can we learn from β-cell failure biomarker application in diabetes in childhood? A systematic review.World journal of diabetes · 2021Article
- Dysbiosis in the Development of Type I Diabetes and Associated Complications: From Mechanisms to Targeted Gut Microbes Manipulation Therapies.International journal of molecular sciences · 2021Review
- The Gut Microbiota Profile According to Glycemic Control in Type 1 Diabetes Patients Treated with Personal Insulin Pumps.Microorganisms · 2021Article
- Epigenetic Effects of Gut Metabolites: Exploring the Path of Dietary Prevention of Type 1 Diabetes.Frontiers in nutrition · 2020Review
- Early Nutrition and Risk of Type 1 Diabetes: The Role of Gut Microbiota.Frontiers in nutrition · 2020Review
- The Effects of Synbiotic Supplementation on Glycemic Status, Lipid Profile, and Biomarkers of Oxidative Stress in Type 1 Diabetic Patients. A Placebo-Controlled, Double-Blind, Randomized Clinical Trial.Diabetes, metabolic syndrome and obesity : targets and therapy · 2020Article
- Maternal Inulin Supplementation Alters Hepatic DNA Methylation Profile and Improves Glucose Metabolism in Offspring Mice.Frontiers in physiology · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe gut microbiome is increasingly recognized as a contributor to disease states. Patients with type 1 diabetes (DM1) have distinct gut microbiota in comparison to non-diabetic individuals, and it has been linked to changes in intestinal permeability, inflammation and insulin resistance. Prebiotics are non-digestible carbohydrates that alter gut microbiota and could potentially improve glycemic control in children with DM1. This pilot study aims to determine the feasibility of a 12-week dietary intervention with prebiotics in children with DM1. METHODS/
designThis pilot study is a single-centre, randomized, double-blind, placebo-controlled trial in children aged 8 to 17 years with DM1 for at least one year. Participants will be randomized to receive either placebo (maltodextrin 3.3 g orally/day) or prebiotics (oligofructose-enriched inulin 8 g orally/day; Synergy1, Beneo, Mannheim, Germany). Measures to be assessed at baseline, 3 months and 6 months include: anthropometric measures, insulin doses/regimens, frequency of diabetic ketoacidosis, frequency of severe hypoglycemia, average number of episodes of hypoglycemia per week, serum C-peptide, HbA1c, serum inflammatory markers (IL-6, IFN-gamma, TNF-alpha, and IL-10), GLP-1 and GLP-2, intestinal permeability using urine assessment after ingestion of lactulose, mannitol and 3-O-methylglucose, and stool sample collection for gut microbiota profiling. DISCUSSION: This is a novel pilot study designed to test feasibility for a fully powered study. We hypothesize that consumption of prebiotics will alter gut microbiota and intestinal permeability, leading to improved glycemic control. Prebiotics are a potentially novel, inexpensive, low-risk treatment addition for DM1 that may improve glycemic control by changes in gut microbiota, gut permeability and inflammation.
trial registrationClinicalTrials.gov: NCT02442544 . Registered on 10 March 2015.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.