Evidence map›Paper›PMID 33771763›Full record

Trial reportBMJ open diabetes research & care2021

Lack of effect of

Lidia Groele, Hania Szajewska, Mieczysław Szalecki, Jolanta Świderska, Marta Wysocka-Mincewicz, Agnieszka Ochocińska, Anna Stelmaszczyk-Emmel, Urszula Demkow, Agnieszka Szypowska

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ open diabetes research & care, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03032354 (Effect of Lactobacillus Rhamnosus GG and Bifidobacterium Lactis BB 12 on Beta-cell Function in Children With Newly Diagnosed Type 1 Diabetes - a Randomized Controlled Trial), which is not on this map. Cited by 34 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 9 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT03032354 phase4unknown statusnot on this map

Effect of Lactobacillus Rhamnosus GG and Bifidobacterium Lactis BB 12 on Beta-cell Function in Children With Newly Diagnosed Type 1 Diabetes - a Randomized Controlled Trial

TypeinterventionalSponsorMedical University of WarsawRan2017 to 2018Enrolled96ConditionsDiabetes Mellitus, Type 1ArmsLactobacillus rhamnosus GG and Bifidobacterium lactis BB12, Placebo, (Placebo group)
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  8. Use of probiotics and similar in pediatric patients with Type 1 Diabetes Mellitus: a systematic review.Revista paulista de pediatria : orgao oficial da Sociedade de Pediatria de Sao Paulo · 2024
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  12. Effect ofNutrients · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Lidia GroeleDepartment of Paediatrics, The Children's Clinical Hospital Józef Polikarp Brudziński, Warsaw, Poland lgroele@wp.pl.ORCID 0000-0003-4453-4381
Hania SzajewskaDepartment of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
Mieczysław SzaleckiClinic of Endocrinology and Diabetology, The Children's Memorial Health Institute, Warsaw, Poland.
Jolanta ŚwiderskaClinic of Endocrinology and Diabetology, The Children's Memorial Health Institute, Warsaw, Poland.
Marta Wysocka-MincewiczClinic of Endocrinology and Diabetology, The Children's Memorial Health Institute, Warsaw, Poland.
Agnieszka OchocińskaDepartment of Biochemistry, Radioimmunology and Experimental Medicine, The Children's Memorial Health Institute, Warsaw, Poland.
Anna Stelmaszczyk-EmmelDeparment of Laboratory Diagnostics and Clinical Immunology of Developmental Age, The Medical University of Warsaw, Warsaw, Poland.
Urszula DemkowDeparment of Laboratory Diagnostics and Clinical Immunology of Developmental Age, The Medical University of Warsaw, Warsaw, Poland.
Agnieszka SzypowskaDepartment of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe gut microbiota may be relevant in the development of type 1 diabetes (T1D). We examined the effects of RESEARCH DESIGN AND

methodsChildren aged 8-17 years with newly (within 60 days) diagnosed T1D were enrolled in a double-blind, randomised controlled trial in which they received

resultsNinety-six children were randomised (probiotics, n=48; placebo n=48; median age 12.3 years). Eighty-eight (92%) completed the 6-month intervention, and 87 (91%) completed the follow-up at 12 months. There was no significant difference between the study groups for the AUC of the C-peptide level. For the secondary outcomes at 6 months, there were no differences between the study groups. At 12 months, with one exception, there also were no significant differences between the groups. Compared with the placebo group, there was a significantly increased number of subjects with thyroid autoimmunity in the probiotic group. However, at baseline, there was also a higher frequency of thyroid autoimmunity in the probiotic group. There were no cases of severe hypoglycemia or ketoacidosis in any of the groups. No adverse events related to the study products were reported.

conclusionsTRIAL REGISTRATION NUMBER: NCT03032354.

Indexed as

Bifidobacterium animalisDiabetes Mellitus, Type 1Gastrointestinal MicrobiomeLacticaseibacillus rhamnosusProbioticsChildDouble-Blind MethodHumanscytokinesdiabetes mellitusinflammationtype 1

Identifiers

PMID33771763
PMCPMC8006832

What OpenQuestion holds

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Read underepoch 390

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.