Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
NCT Number: NCT06487299
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Nanjing, Jiangsu, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The injection solution was 3 ferrous lactate (10ml:0.1g iron) mixed with 20ml saline.
Other names: PURAMEX(R)
The injection was 3 shots of ferrous lactate (5ml:100mg iron) mixed with 35ml saline.
Other names: Iron saccharate
The same volume and color as Iron sucrose.
Other names: saline (medicine)
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.
Time frame: Baseline; Day 4
To compare the level of ferritin in the serum before and after administration of iron lactate, iron sucrose and saline.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Bota Cui
CONTACT
Faming Faming, PhD
CONTACT
The Second Hospital of Nanjing Medical University
Other
Iron Administration Via Colonic Transendoscopic Enteral Tubing Combined With Washed Microbiota Transplantation for Iron Deficiency:A Double-blind Randomized Controlled Trial
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