Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications
Conditions
Interventions
None listed
Sponsors
Arogyaseva Medical Academy of India AMAI
Eligibility
Inclusion criteria
Inclusion criteria: i.Adult male and non-pregnant females aged 18 to 65 years ii.Patients who have weak gut health characterized by either constipation or diarrhea (more than 2 episodes per day in the past 5 days) iii.Patients who are diabetic with CKD non-dialysis will be considered in the study. iv.Able to comply with all required study procedures and schedule. v.Able to comply and willing to follow the prescribed diet plan. vi.Willing and able to give written informed consent.
Exclusion criteria
Exclusion criteria: i.Patient on antibiotics or vitamin supplement (except vitamin D analogs) in the last three months. ii.Advanced liver disease, advanced cardiovascular disease, heart failure with EF iii.The use of chemotherapy, antibiotics, immunosuppressive medications, probiotics, and steroid in the last three month. iv.Intravenous or oral iron supplementation, laxatives, and kayexalate in the last month. v.History of intra-abdominal surgery, small or large intestine resection or small bowel obstruction. vi.History of colon cancer or gastrointestinal bleed. vii.Patient who has participated in a clinical study within the last 30 days prior to entering this study. viii.Patients with hypersensitivity to any of the ingredients of the study products. ix.Patients who are taking immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| i. Change in Abdominal pain scale from baseline to end of the treatment. ii. Average scores of gastrointestinal symptoms by questionnaire from baseline to end of the treatment.Timepoint: Baseline to end of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Changes or % incidence of adverse events, laboratory test results, vital signs between the groups from their screening visit to end of treatment. ii. Percentage (%) change in the TNF alpha ILF, IL8 between the groups from their screening visit to end of treatment. iii. Percentage (%) change in the pathogenic microbiome (fecal) between the groups from their screening visit to end of treatment. iv. Percentage (%) change in the non-pathogenic microbiome (fecal) between the groups from their screening visit to end of treatment. v. Changes in the uremic metabolites (uric acid, creatinine) between the groups from their screening visit to end of treatment. vi. Percentage (%) change in the associated symptoms of uremia between the groups from their screening visit to end of treatment.Timepoint: Baseline to End of the treatment | — |
Countries
India
Contacts
Public ContactMr C Devanpally
Ardent Clinical Research Services
Outcome results
None listed