Evidence map›Paper›PMID 31472678›Full record

ArticleNutrition journal2019

The study evaluating the effect of probiotic supplementation on the mental status, inflammation, and intestinal barrier in major depressive disorder patients using gluten-free or gluten-containing diet (SANGUT study): a 12-week, randomized, double-blind, and placebo-controlled clinical study protocol.

Hanna Karakula-Juchnowicz, Joanna Rog, Dariusz Juchnowicz, Igor Łoniewski, Karolina Skonieczna-Żydecka, Paweł Krukow, Malgorzata Futyma-Jedrzejewska, Mariusz Kaczmarczyk

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Nutrition journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 43 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 4 pooled it
2.7field-weighted citation impact, top 9% of its field
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.

NCT03877393 naunknown statusnot on this map

A 12-week, Randomized, Double-blind, and Placebo-controlled Study Evaluating the Effect of Probiotic Supplementation on the Mental Status, Inflammation, And Intestinal Barrier in Major Depressive Disorder Patients Using Gluten-free or Gluten-containing Diet

TypeinterventionalSponsorMedical University of LublinRan2019 to 2021Enrolled120ConditionsDepressive Disorder, Major, DepressionArmsProbiotic supplementation + gluten-free diet, Placebo supplementation + gluten-free diet, Probiotic supplementation + gluten-containing diet, Placebo supplementation + gluten-containing diet
NCT06860581 nacompletednot on this mapstarted 2023, after this paper: background citation

The Impact of Dietary Supplementation With Lactobacillus Helveticus and Bifidobacterium Longum on the Functioning of the Brain-gut Axis, in the Context of Mental Health, Eating Patterns and Nutritional Status of Young Adults

TypeinterventionalSponsorPoznan University of Life SciencesRan2023 to 2024Enrolled120ConditionsHealthy Volunteers, Young Adult, WomenArmsIntervention (Sanprobi®Stress), Placebo
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 4 syntheses or guidelines pooled it, 89 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Nutraceuticals in Psychiatric Disorders: A Systematic Review.International journal of molecular sciences · 2024
    Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Article
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. Probiotics in reducing obesity by reconfiguring the gut microbiota.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2024
    Review
  20. Article
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

8 authors at 3 institutions in 1 country.

Hanna Karakula-Juchnowicz1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin, Głuska 1, 20-439, Lublin, Poland.
Joanna Rog1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin, Głuska 1, 20-439, Lublin, Poland. rog.joann@gmail.com.
Dariusz JuchnowiczDepartment of Psychiatric Nursing, Medical University of Lublin, 20-124, Lublin, Poland.
Igor ŁoniewskiDepartment of Biochemistry and Human Nutrition, Pomeranian Medical University, 71-460, Szczecin, Poland.
Karolina Skonieczna-ŻydeckaDepartment of Biochemistry and Human Nutrition, Pomeranian Medical University, 71-460, Szczecin, Poland.
Paweł KrukowDepartment of Clinical Neuropsychiatry, Medical University of Lublin, 20-439, Lublin, Poland.
Malgorzata Futyma-Jedrzejewska1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin, Głuska 1, 20-439, Lublin, Poland.
Mariusz KaczmarczykDepartment of Clinical and Molecular Biochemistry, Pomeranian Medical University, 70-111, Szczecin, Poland.
Medical University of Lublin · PLPomeranian Medical University · PLUniversity of Szczecin · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrent treatment of major depressive disorder (MDD) often does not achieve full remission of symptoms. Therefore, new forms of treatment and/or adjunct therapy are needed. Evidence has confirmed the modulation of the gut-brain-microbiota axis as a promising approach in MDD patients. The overall purpose of the SANGUT study-a 12-week, randomized, double-blind, and placebo-controlled Study Evaluating the Effect of Probiotic Supplementation on the Mental Status, Inflammation, and Intestinal Barrier in Major Depressive Disorder Patients Using Gluten-free or Gluten-containing Diet - is to determine the effect of interventions focused on the gut-brain-microbiota axis in a group of MDD patients.

methodsA total of 120 outpatients will be equally allocated into one of four groups: (1) probiotic supplementation+gluten-free diet group (PRO-GFD), (2) placebo supplementation+ gluten-free diet group (PLA-GFD), (3) probiotic supplementation+ gluten containing diet group (PRO-GD), and (4) placebo supplementation+gluten containing diet group (PLA-GD). PRO groups will receive a mixture of psychobiotics (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175), and GFD groups will follow a gluten-free diet. The intervention will last 12 weeks. The primary outcome measure is change in wellbeing, whereas the secondary outcome measures include physiological parameters. DISCUSSION: Microbiota and its metabolites have the potential to influence CNS function. Probiotics may restore the eubiosis within the gut while a gluten-free diet, via changes in the microbiota profile and modulation of intestinal permeability, may alter the activity of microbiota-gut-brain axis previously found to be associated with the pathophysiology of depression. It is also noteworthy that microbiota being able to digest gluten may play a role in formation of peptides with different immunogenic capacities. Thus, the combination of a gluten-free diet and probiotic supplementation may inhibit the immune-inflammatory cascade in MDD course and improve both psychiatric and gut barrier-associated traits.

trial registrationNCT03877393 .

Indexed as

AdultDietDiet, Gluten-FreeDouble-Blind MethodFemaleGastrointestinal MicrobiomeGlutensHumansInflammationIntestinesMajor Depressive DisorderMaleProbioticsProspective StudiesRandomized Controlled Trials as TopicGlutensDepressionEEG functional connectivityGluten-free dietGut-brain axisGut microbiotaGut permeabilityInflammationIntervention studyProbioticsStudy protocol

Identifiers

PMID31472678
PMCPMC6717641
OpenAlexW2971160532

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.