Health Condition 1: E638- Other specified nutritional deficiencies
Conditions
Interventions
Intervention1: NIL: NIL
Control Intervention1: NIL: NIL
Sponsors
MicrobioTx Health Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 IBS 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) and 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)Timepoint: The single time point at which the data will be analysed will be 26 weeks from the start of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Design probiotic formulation to improve gut health in NAFLD patientsTimepoint: The single time point at which the data will be analysed will be 1 year from the start of the study. | — |
Countries
India
Contacts
Public ContactDr Palok Aich
MicrobioTx Health Private Limited
Outcome results
None listed