Hemopathy
Conditions
Interventions
treatment arm:Montmorillonite powder 3g biw, 6 months
control arm:Placebo 3g biw, 6 months
Sponsors
Nanjing Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Patients with blood diseases who have undergone allogeneic hematopoietic stem cell transplantation; 2) Patients with lacks or inadequate lactobacillus colonization of fecal flora; 3) Age between 18~65 years old, gender is not limited; 4) Patients receive treatment voluntarily and sign the informed consent form, and the informed consent process complies with the relevant provisions of GCP.
Exclusion criteria
Exclusion criteria: 1) Patients with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney diseases, hyperthyroidism, diabetes, inflammatory bowel disease, or serious diseases (such as secondary tumors, etc.) that affect their survival and psychiatric patients; 2) Women who are pregnant or planning to become pregnant or breastfeeding; 3) Those who are suspected or have a history of alcohol or drug abuse; 4) Those with cognitive dysfunction who cannot give full informed consent; 5) Patients who have used drugs to treat microflora disorders within 2 weeks and have participated in other clinical trials within 1 month; 6) Patients who have undergone abdominal surgery within 6 months; 7) Those who have general or special contraindications to the drug provided; 8) Patients with habitual constipation and intestinal infections; 9) Patients who are considered by the investigator to have factors that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Times of intestinal flora changes and immune reconstitution in both groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| The frequency of diarrhea in both groups;Changes in minimal residual diseases before and after treatment in both groups; | — |
Countries
China
Contacts
Public ContactXu Peipei
Nanjing Drum Tower Hospital
Outcome results
None listed