Identify microbial and metabolic biomarkers for building gut profile of a.) Depression and b.) Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sensitivity: Sensitivity is defined as (the number of microbes called within normal range by both the standard of care and MicrobioTx)/(number of microbes called within normal range by the standard of care)
研究概览
简要总结
Disorders of Anxiety and Depression, as well Gastro-Intestinal disorders are two highly prevalent diseases with high burden on the healthcare system. Depression may overtake heart failure as the most prevalent disease in the world by 2030.
These diseases have two things in common - absence of a diagnostic marker, and the presence of gut microbial dysbiosis. Both these diseases are classified based on self-reported or clinically observable symptoms alone. Imbalances of the gut microbiota are also well documented. The human gut has the second-highest concentration of neurons after the brain, and several studies have shown that the gut–brain axis influences the development of anxiety and depression. The importance of gut microbiota dysbiosis in IBS is highlighted by the fact that triggers for IBS such as infections, poor sleep, antibiotic use, diet, and stress can affect intestinal microbiota composition.
The major theme of the current proposal is to develop high-throughput, sensitive, and rapid metabolomic (MS/MS), and metagenomic (fecal microbiome) methodologies to correlate metabolite (from serum) and microbial (from fecal samples) markers in human patients for the above diseases.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •For depression subgroup.
- •Patients with mild-moderate-severe depression, as defined by ICD-11, classified on the basis of self-reported responses to The International Depression Questionnaire (IDQ) 3) For IBS subgroup.
- •Patients with IBS as per Rome III diagnostic criteria. Rome III criteria for diagnosis of IBS is mentioned as below.
- •A patient might have IBS if they recurrent abdominal pain or discomfort for at least three days a month for the last three months, associated with two or more of the following criteria: â— Improvement with defecation â— Onset associated with a change in frequency of stool â— Onset associated with a change in form or appearance of stool Symptom onset greater than 6 months prior to the diagnosis, with the above criteria fulfilled for the past 3 months. Discomfort means an uncomfortable sensation not described as pain. 4) Patients who have normal general health and normal findings on clinical history, physical examination, blood count, no other abnormal clinical or ultrasonographic findings will be included in this study.
排除标准
- •Any active illness, psychological and/or pathological condition or chronic disease that would interfere with study participation in the opinion of the Investigator.
- •Participants with a history of alcohol consumption exceeding 20 grams per day (both male and female)
- •Participants taking immunosuppressants, tamoxifen, amiodarone and/or perhexiline;
- •Participants who have taken antibiotics in the last 3 months
- •Type 2 diabetes mellitus on insulin, or other glucose lowering therapy (eg GLP-1 agonists, SGLT2- inhibitors and DPP4 inhibitors)
- •Those who are on drugs, which are likely to induce insulin sensitization such as estrogens, amiodarone, methotrexate, tamoxifen, pioglitazones and metformin.
- •Concurrent gastrointestinal diagnosis with symptoms that could mimic IBS
- •Pregnant and lactating females
- •Contraindications including bulimia nervosa, substance abuse, change in dose/regime or introduction of vitamin E, C or high dose vitamin D, fish oil or probiotics.
- •Subjects who have undergone previous abdominal surgery except appendectomy, caesarean section, tubal ligation, laparoscopic cholecystectomy, hysterectomy or abdominal wall hernia repair.
结局指标
主要结局
Sensitivity: Sensitivity is defined as (the number of microbes called within normal range by both the standard of care and MicrobioTx)/(number of microbes called within normal range by the standard of care)
时间窗: The single time point at which the data will be analysed will be 26 weeks from the start of the study.
and
时间窗: The single time point at which the data will be analysed will be 26 weeks from the start of the study.
Specificity: Specificity is defined as (number of microbes called deficient by both the standard of care and by MicrobioTx)/(number of microbes called deficient by standard of care)
时间窗: The single time point at which the data will be analysed will be 26 weeks from the start of the study.
次要结局
- Design probiotic formulation to improve gut health in NAFLD patients(The single time point at which the data will be analysed will be 1 year from the start of the study.)
研究者
Dr Palok Aich
MicrobioTx Health Private Limited