51. 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
- Author
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Joanna Rog, Dariusz Juchnowicz, Małgorzata Futyma-Jędrzejewska, Igor Łoniewski, Paweł Krukow, Mariusz Kaczmarczyk, Hanna Karakuła-Juchnowicz, and Karolina Skonieczna-Żydecka
- Subjects
0301 basic medicine ,Male ,Medicine (miscellaneous) ,Gut flora ,Gastroenterology ,law.invention ,Probiotic ,Study Protocol ,0302 clinical medicine ,law ,Medicine ,Prospective Studies ,lcsh:RC620-627 ,chemistry.chemical_classification ,Nutrition and Dietetics ,biology ,Depression ,Intervention study ,Intestines ,lcsh:Nutritional diseases. Deficiency diseases ,Gluten-free diet ,Major depressive disorder ,Female ,lcsh:Nutrition. Foods and food supply ,Gut-brain axis ,Adult ,medicine.medical_specialty ,Glutens ,Gut–brain axis ,030209 endocrinology & metabolism ,lcsh:TX341-641 ,Gut microbiota ,Placebo ,digestive system ,03 medical and health sciences ,Diet, Gluten-Free ,Double-Blind Method ,Internal medicine ,Humans ,Gut permeability ,Inflammation ,Depressive Disorder, Major ,030109 nutrition & dietetics ,Intestinal permeability ,business.industry ,Probiotics ,biology.organism_classification ,medicine.disease ,Gluten ,Diet ,Gastrointestinal Microbiome ,chemistry ,Gluten free ,business ,EEG functional connectivity - Abstract
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. 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. 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. NCT03877393 .
- Published
- 2019