A Pilot Study of Synbiotics in Adults With Depressive Symptoms

Официальное название

A Pilot Study on the Efficacy of a Synbiotic Formula (MQU10) in Improving Mood and Well-being in Adults With Mild to Moderate Depressive Symptoms

Обзор

This study aims to explore the efficacy and safety of a synbiotic formula (MQU10) in improving mood and well-being in adults with mild to moderate depressive symptoms.

Подробное описание

Major depression disorder (MDD) affects up to 20% of the population. In Hong Kong, one in seven suffered from mental health disorders with depressive disorder being one of the most frequent diagnoses. Depression is characterized by persistently low mood and loss of interest, possibly resulting from multifactorial factors including brain chemical abnormalities, genetics, stress, trauma and medical conditions. Current treatments for depression mainly include medication that alters neurotransmission in the brain and cognitive behavioural therapy to change cognitive distortions and their associated behaviours. However, there are side effects associated with the use of antidepressant medications as well as perceived stigma in receiving antidepressants and the uptake and accessibility of psychotherapy is extremely low. Thus, alternative therapeutic options are therefore needed to manage depression and its associated symptoms.

Emerging evidence suggests the important role of gut microbiota and gut-brain axis in mood regulation. In particular, there is high comorbidity among individuals with depression and gastrointestinal conditions such as irritable bowel syndrome and inflammatory bowel disease. There is also evidence suggesting that gut microbiota could produce metabolites and compounds with neuroactive and immunomodulatory properties. Previous studies have also supported the association between the dysbiosis of gut microbiota and affective disorders. Clinical trials on the use of microbiome-based therapeutics showed some efficacy in improving depression and insomnia. Gut microbiota modulation could be a novel therapeutic strategy for improving mood problems.

This pilot, single-arm study aims to explore the efficacy and safety of a synbiotic formula (MQU10), which is composed of food-grade probiotic strains and prebiotic compounds, in improving mood and well-being in adults with mild to moderate depressive symptoms.

Вмешательства

• Пищевая добавка MQU10
  MQU10 consists of a blend of food-grade probiotic strains (20 billion CFU daily) and prebiotic compounds.

Первичные конечные точки

• Proportions of subjects with improvement in condition, assessed by the Clinical Global Impression - Global Improvement Scale (CGI-I) at 6 weeks [Срок оценки: 6 weeks]

Вторичные конечные точки (6)

• Self-report improvement in condition, assessed by Patient Global Impression of Change scale (PGI-C) by 6 weeks [Срок оценки: 6 weeks]
• Changes in depression level, assessed by Patient Health Questionnaire-9 (PHQ-9) by 6 weeks [Срок оценки: 6 weeks]
• Changes in anxiety level, assessed by Generalised Anxiety Disorder 7-item scale (GAD-7) by 6 weeks [Срок оценки: 6 weeks]
• Changes in health-related quality of life, assessed by World Health Organization Quality of Life-BREF (WHOQOL-BREF) by 6 weeks [Срок оценки: 6 weeks]
• Changes in gut microbiota composition and functions by 6 weeks [Срок оценки: 6 weeks]
• Adverse events by 6 weeks [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• Individuals aged 18 or above
• Patient Health Questionnaire-9 (PHQ-9) score between 5 to 14
• Literate and can complete the self-report questionnaires
• Able to understand the consent and sign the informed consent form

Критерии исключения

• Current diagnosis of substance abuse or dependence;
• A current or past history of bipolar disorder, manic or hypomanic episodes, schizophrenia, personality disorder, posttraumatic stress disorder (PTSD), intellectual disability, neurodegenerative disorders (e. g, Parkinson's disease) or organic mental disorder
• Requiring immediate psychiatric care (e. g, imminently suicidal subjects) or have attempted suicide in the past 3 months
• Use of antipsychotics, antidepressants or sedatives, unless on a stable dose in the last 4 weeks
• History of severe organ failure, renal failure on dialysis, HIV infection
• Active malignancy within 5 years
• History of major surgery on the gastrointestinal tract, except cholecystectomy and appendectomy in the past 5 years
• Night shift work
• History of antibiotic use within 4 weeks
• History of allergy to probiotics or lactose leading to a severe allergic reaction
• Known pregnancy or lactating

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Гонконг · 2 центра

• GenieBiome Limited — Гонконг
• Healthymind Centre — Гонконг

Публикации

• Yong SJ, Tong T, Chew J, Lim WL. Antidepressive Mechanisms of Probiotics and Their Therapeutic Potential. Front Neurosci. 2020 Jan 14;13:1361. doi: 10.3389/fnins.2019.01361. eCollection 2019. PMID 32009871
• Poluektova E, Yunes R, Danilenko V. The Putative Antidepressant Mechanisms of Probiotic Bacteria: Relevant Genes and Proteins. Nutrients. 2021 May 10;13(5):1591. doi: 10.3390/nu13051591. PMID 34068669
• Huang R, Wang K, Hu J. Effect of Probiotics on Depression: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Nutrients. 2016 Aug 6;8(8):483. doi: 10.3390/nu8080483. PMID 27509521
• Lau RI, Su Q, Lau ISF, Ching JYL, Wong MCS, Lau LHS, Tun HM, Mok CKP, Chau SWH, Tse YK, Cheung CP, Li MKT, Yeung GTY, Cheong PK, Chan FKL, Ng SC. A synbiotic preparation (SIM01) for post-acute COVID-19 syndrome in Hong Kong (RECOVERY): a randomised, double-blind, placebo-controlled trial. Lancet Infect Dis. 2024 Mar;24(3):256-265. doi: 10.1016/S1473-3099(23)00685-0. Epub 2023 Dec 7. PMID 38071990
• Pirbaglou M, Katz J, de Souza RJ, Stearns JC, Motamed M, Ritvo P. Probiotic supplementation can positively affect anxiety and depressive symptoms: a systematic review of randomized controlled trials. Nutr Res. 2016 Sep;36(9):889-898. doi: 10.1016/j.nutres.2016.06.009. Epub 2016 Jun 21. PMID 27632908
• Ito H, Tomura Y, Kitagawa Y, Nakashima T, Kobanawa S, Uki K, Oshida J, Kodama T, Fukui S, Kobayashi D. Effects of probiotics on sleep parameters: A systematic review and meta-analysis. Clin Nutr ESPEN. 2024 Oct;63:623-630. doi: 10.1016/j.clnesp.2024.07.006. Epub 2024 Aug 2. PMID 39094854
• Gil-Hernandez E, Ruiz-Gonzalez C, Rodriguez-Arrastia M, Ropero-Padilla C, Rueda-Ruzafa L, Sanchez-Labraca N, Roman P. Effect of gut microbiota modulation on sleep: a systematic review and meta-analysis of clinical trials. Nutr Rev. 2023 Nov 10;81(12):1556-1570. doi: 10.1093/nutrit/nuad027. PMID 37023468
• Li Y, Hao Y, Fan F, Zhang B. The Role of Microbiome in Insomnia, Circadian Disturbance and Depression. Front Psychiatry. 2018 Dec 5;9:669. doi: 10.3389/fpsyt.2018.00669. eCollection 2018. PMID 30568608

Идентификаторы

NCT: NCT06905223 · AM01 (GB)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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