CTRI/2024/07/070846尚未招募Unknown
Identify microbial and metabolic biomarkers for building gut profile of a.) Depression and b.) Irritable Bowel Syndrome - NI
MicrobioTx Health Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
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:
- •? Improvement with defecation
- •? Onset associated with a change in frequency of stool
- •? 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
- •1. Any active illness, psychological and/or pathological condition or chronic
- •disease that would interfere with study participation in the opinion of the
- •Investigator.
- •2. Participants with a history of alcohol consumption exceeding 20 grams
- •per day (both male and female)
- •3. Participants taking immunosuppressants, tamoxifen, amiodarone and/or
- •perhexiline;
- •4. Participants who have taken antibiotics in the last 3 months
- •5. Type 2 diabetes mellitus on insulin, or other glucose lowering therapy (eg
- •GLP-1 agonists, SGLT2- inhibitors and DPP4 inhibitors)
- •6. Those who are on drugs, which are likely to induce insulin sensitization
- •such as estrogens, amiodarone, methotrexate, tamoxifen, pioglitazones
- •and metformin.
- •7. Concurrent gastrointestinal diagnosis with symptoms that could mimic
- •8. Pregnant and lactating females
- •9. 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.
- •10. Subjects who have undergone previous abdominal surgery except
- •appendectomy, caesarean section, tubal ligation, laparoscopic
- •cholecystectomy, hysterectomy or abdominal wall hernia repair
研究者
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