NCT03281044

Fecal Microbiota Transplantation in Depression

Terminated Phase 2 Last updated 16 April 2020

What this trial tests

Phase 2 trial testing Fecal microbiota capsules in Major Depressive Disorder in 4 participants. Terminated before completion.

Timeline

24 October 2018

Primary endpoint
16 March 2020

16 March 2020

Quick facts

Lead sponsor	Psychiatric Hospital of the University of Basel
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	4
Start date	24 October 2018
Primary completion	16 March 2020
Estimated completion	16 March 2020
Sites	1 location across Switzerland

Drugs / interventions tested

• Fecal microbiota capsules — full drug profile →
• Placebo oral capsule

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Psychiatric Hospital of the University of Basel

Who can join

Adults 18 to 60, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The prevalence of psychiatric disorders such as major depression disorder (MDD) is increasing rapidly. Despite advancements in the development of therapeutics, current treatment options have not reached optimal efficacy.

Recent interest has been drawn towards the importance of the biochemical signalling between the gastrointestinal tract and the central nervous system also known as the "microbiome-gut-brain axis". The pathogenesis of gut microbiota in extra intestinal diseases was inspired by massive studies in germ free (GF) animals, which indicated that the gut microbiota plays a role in the normal regulation of behaviour that are relevant to mood, anxiety and stress. However, the exact mechanisms by which intestinal dysbiosis are involved in the development of psychiatric diseases are not completely clarified.

A new method to alter the composition of the gastrointestinal microbiota involves fecal microbiota transplantation (FMT). The goal of FMT is to introduce or restore a stable microbial community in the gut by transplanting intestinal microbiota from a healthy donor to the patient. FMT, as a microbiota-target therapy, is arguably very effective for curing recurrent Clostridium difficile infection and has good outcomes in other intestinal diseases. At the same time, applications in previously unexpected areas, including metabolic diseases, neuropsychiatric disorders, autoimmune diseases, allergic disorders, and tumors have shown health enhancing results. FMT has initially been conducted using colonoscopy. However, recent evidence has shown that treatment with frozen FMT capsules (to be taken orally) is also safe and beneficial in restoring the gut microbiota in patients with various diseases As FMT capsules may be an effective, pragmatical adjuvant therapy (in addition to standard treatment) for depression, this project is aimed at (1) investigating for the first time if single administration of FMT capsules ameliorates depressive symptoms in patients with moderate to severe MDD 4 weeks after treatment and (2) establishing the safety profile of encapsulated FMT in MDD. Furthermore, we will also test if (3) FMT capsules modulates immune signalling and inflammatory processes, (4) Hypothalamic-pituitary-adrenal (HPA) axis responses, (5) neurogenesis, (6) energy balance hormones, (7) gut microbiota composition and (8) brain perfusion, structure and activation.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fecal microbiota transplantation beyond Clostridioides difficile infections.
   Wortelboer K, Nieuwdorp M, Herrema H. · · 2019 · cited 111× · PMID 31201141 · DOI 10.1016/j.ebiom.2019.05.066
2. Fecal Microbiota Transplantation: A New Therapeutic Attempt from the Gut to the Brain.
   Xu HM, Huang HL, Zhou YL, Zhao HL, et al · · 2021 · cited 59× · PMID 33510784 · DOI 10.1155/2021/6699268
3. Inflamed brain: Targeting immune changes and inflammation for treatment of depression.
   Sakamoto S, Zhu X, Hasegawa Y, Karma S, et al · · 2021 · cited 37× · PMID 34227186 · DOI 10.1111/pcn.13286
4. The forgotten oral microbial transplantation for improving the outcomes of COVID-19.
   AbdelMassih A, Gadalla M, Hussein E, Elahmady M, et al · · 2021 · cited 3× · PMID 34336224 · DOI 10.1016/j.nmni.2021.100923