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.
Study Goal
The researchers aimed to determine the effect of a gluten-free diet, alone or combined with probiotic supplementation, on mental status, inflammation, and intestinal barrier function in patients with major depressive disorder.
Results Summary
The study suggests that a gluten-free diet, particularly when combined with probiotics, may modulate the gut-brain-microbiota axis, potentially improving psychiatric symptoms and gut barrier function in MDD patients. However, specific results on efficacy are pending as the study is ongoing.
Population
120 outpatients with major depressive disorder (MDD).
Effective Dosage
Not specified for gluten-free diet; probiotics included Lactobacillus helveticus R0052 and Bifidobacterium longum R0175.
Duration
12 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
modulation of the gut-brain-microbiota axis | neutral | treatment of major depressive disorder | MDD patients | - | is a promising approach | #1 |
probiotic supplementation | increase | eubiosis within the gut | - | - | may restore | #2 |
gluten-free diet | neutral | activity of microbiota-gut-brain axis | - | - | may alter | #3 |
combination of a gluten-free diet and probiotic supplementation | decrease | immune-inflammatory cascade in MDD course | - | - | may inhibit | #4 |
combination of a gluten-free diet and probiotic supplementation | increase | psychiatric and gut barrier-associated traits | - | - | may improve | #5 |
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 .