Iron Deficiency Anemia in Childbirth
Conditions
Keywords
Iron, Transendoscopic enteral tubing, Washed Microbiota Transplantation, iron deficiency
Brief summary
The colon can absorb iron.We propose an integrated approach utilizing colonic transendoscopic enteral tubing to deliver iron in different valence states, coupled with washed microbiota transplantation . This clinical trial aims to assess the feasibility, safety, and efficacy of this approach for the treatment of iron deficiency.
Detailed description
At least 60 subjects who meet all the inclusion criteria but do not meet any exclusion criteria will be enrolled in this study. Data of demographic characteristics, reticulocyte hemoglobin, ferritin and clinical outcomes will be collected. After treatment, they will enter the follow-up period for safety and efficacy evaluation.
Interventions
DRUGFerrous Lactate
The injection solution was 3 ferrous lactate (10ml:0.1g iron) mixed with 20ml saline.
DRUGIron sucrose
The injection was 3 shots of ferrous lactate (5ml:100mg iron) mixed with 35ml saline.
The same volume and color as Iron sucrose.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. ferritin ≤30 μg/L; 2. feasible colonic TET placement (cephalic end in the ileocecal region); 3. completion of 3 WMT sessions.
Exclusion criteria
1. The patient has other co-morbidities that can lead to iron deficiency, such as acute gastrointestinal haemorrhage and menorrhagia.etc. 2. People who are allergic to iron or taking oral medications that interfere with iron absorption. 3. Patients with heart, brain, lung, liver, kidney and other serious diseases; 4. Patients do not cooperate to complete the clinical trial process;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reticulocyte haemoglobin values in blood | Baseline; Day 4 | To compare the level of reticulocyte haemoglobin in the blood before and after administration of iron lactate, iron sucrose and saline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum ferritin levels | Baseline; Day 4 | To compare the level of ferritin in the serum before and after administration of iron lactate, iron sucrose and saline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Baseline; Day 4 | The number of adverse reactions that are associated with iron medicine reported by subjects from the start of treatment to the end of follow-up. |
Countries
China
Contacts
Primary ContactFaming Faming, PhD
Backup ContactBota Cui
Outcome results
None listed