Iron Administration Via Colonic Transendoscopic Enteral Tubing Combined With Washed Microbiota Transplantation for Iron Deficiency:A Double-blind Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Reticulocyte haemoglobin values in blood
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ferritin ≤30 μg/L;
- •feasible colonic TET placement (cephalic end in the ileocecal region);
- •completion of 3 WMT sessions.
Exclusion Criteria
- •The patient has other co-morbidities that can lead to iron deficiency, such as acute gastrointestinal haemorrhage and menorrhagia.etc.
- •People who are allergic to iron or taking oral medications that interfere with iron absorption.
- •Patients with heart, brain, lung, liver, kidney and other serious diseases;
- •Patients do not cooperate to complete the clinical trial process;
Arms & Interventions
Ferrous Lactate
Ferrous lactate is administered via the colon as an injectable solution at a dose of 300 mg per day for 3 days, with saline added to 50ml.
Intervention: Ferrous Lactate (Drug)
Iron Sucrose
Iron sucrose is administered via the colon as an injectable solution at a dose of 300mg per day for 3 days, with saline added to 50ml.
Intervention: Iron sucrose (Drug)
Saline
0.9% sodium chloride is administered via the colon as an injectable solution at a dose of 50ml per day for 3 days.
Intervention: 0.9% NaCl solution (Drug)
Outcomes
Primary Outcomes
Reticulocyte haemoglobin values in blood
Time Frame: 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 Outcomes
- Serum ferritin levels(Baseline; Day 4)
Investigators
Faming Zhang
Professor, Gastroenterology
The Second Hospital of Nanjing Medical University