NCT02855762

Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder

Completed NA Last updated 1 February 2019

What this trial tests

NA trial testing High polyunsaturated fatty acid diet. in Bipolar Disorder in 10 participants. Completed in 31 January 2019.

Timeline

8 September 2016

Primary endpoint
31 January 2019

31 January 2019

Quick facts

Lead sponsor	Melvin McInnis, MD
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	10
Start date	8 September 2016
Primary completion	31 January 2019
Estimated completion	31 January 2019
Sites	1 location across United States

Drugs / interventions tested

• High polyunsaturated fatty acid diet.

Conditions studied

• Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

Melvin McInnis, MD

Who can join

Adults 25 to 65, any sex, with Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to determine how specific dietary control alters the microbiome composition to effect clinical outcome measures in a longitudinal study of individuals with bipolar disorder. Our central hypothesis is that a low carbohydrate (CHO) / high polyunsaturated fat (PUFA) diet will increase the fractional representation of specific butyrate producing members of the Firmicutes phylum in the gut microbiome, which will attenuate host inflammation, improve sleep quality and reduce anxiety in bipolar patients. The rationale for the proposed research is to take the first step in a continuum of studies to develop personalized novel approaches to treat mood disorders, including the need to address gut dysbiosis, which often co-occurs with mental illness. The investigators will test our hypothesis and achieve the objective of this proposal with the following Specific Aims: 1) Determine the taxonomical change in the stool microbiome following a low CHO / high PUFA diet; and 2) Determine the changes in sleep quality, anxiety, and depression following a low CHO / high PUFA diet. These aims will be achieved using the unique resources at the University of Michigan, including the Nutrition Assessment Laboratory for dietary intervention, the Host-Microbiome Laboratory for microbial assays, and the ongoing Prechter Longitudinal Study of Bipolar Disorder. At the end of the proposed studies the investigators expect to set the stage for future studies to assess neurochemical mechanisms. These data will provide a greater understanding of the mechanism by which diet controls the specific microbes in the gut microbiome to affect mood disorders and gut dysbiosis and improve response to psychiatric treatment paradigms.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.