Tags

Type your tag names separated by a space and hit enter

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.
Nutr J. 2019 08 31; 18(1):50.NJ

Abstract

BACKGROUND

Current 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.

METHODS

A 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 REGISTRATION

NCT03877393 .

Authors+Show Affiliations

1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin, Głuska 1, 20-439, Lublin, Poland. Department of Clinical Neuropsychiatry, Medical University of Lublin, 20-439, Lublin, Poland.1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin, Głuska 1, 20-439, Lublin, Poland. rog.joann@gmail.com.Department of Psychiatric Nursing, Medical University of Lublin, 20-124, Lublin, Poland.Department of Biochemistry and Human Nutrition, Pomeranian Medical University, 71-460, Szczecin, Poland. Sanprobi sp. z o.o. sp. k, Szczecin, Poland.Department of Biochemistry and Human Nutrition, Pomeranian Medical University, 71-460, Szczecin, Poland.Department of Clinical Neuropsychiatry, Medical University of Lublin, 20-439, Lublin, Poland.1st Department of Psychiatry, Psychotherapy and Early Intervention, Medical University of Lublin, Głuska 1, 20-439, Lublin, Poland.Department of Clinical and Molecular Biochemistry, Pomeranian Medical University, 70-111, Szczecin, Poland.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31472678

Citation

Karakula-Juchnowicz, Hanna, et al. "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." Nutrition Journal, vol. 18, no. 1, 2019, p. 50.
Karakula-Juchnowicz H, Rog J, Juchnowicz D, et al. 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. Nutr J. 2019;18(1):50.
Karakula-Juchnowicz, H., Rog, J., Juchnowicz, D., Łoniewski, I., Skonieczna-Żydecka, K., Krukow, P., Futyma-Jedrzejewska, M., & Kaczmarczyk, M. (2019). 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. Nutrition Journal, 18(1), 50. https://doi.org/10.1186/s12937-019-0475-x
Karakula-Juchnowicz H, et al. 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. Nutr J. 2019 08 31;18(1):50. PubMed PMID: 31472678.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Karakula-Juchnowicz,Hanna, AU - Rog,Joanna, AU - Juchnowicz,Dariusz, AU - Łoniewski,Igor, AU - Skonieczna-Żydecka,Karolina, AU - Krukow,Paweł, AU - Futyma-Jedrzejewska,Malgorzata, AU - Kaczmarczyk,Mariusz, Y1 - 2019/08/31/ PY - 2019/05/08/received PY - 2019/08/16/accepted PY - 2019/9/2/entrez PY - 2019/9/2/pubmed PY - 2020/5/5/medline KW - Depression KW - EEG functional connectivity KW - Gluten-free diet KW - Gut microbiota KW - Gut permeability KW - Gut-brain axis KW - Inflammation KW - Intervention study KW - Probiotics KW - Study protocol SP - 50 EP - 50 JF - Nutrition journal JO - Nutr J VL - 18 IS - 1 N2 - BACKGROUND: Current 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. METHODS: A 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 REGISTRATION: NCT03877393 . SN - 1475-2891 UR - https://www.unboundmedicine.com/medline/citation/31472678/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_ L2 - https://nutritionj.biomedcentral.com/articles/10.1186/s12937-019-0475-x DB - PRIME DP - Unbound Medicine ER -