NCT06487299

Iron Administration Via Colonic TET Combined With WMT for ID

Iron Administration Via Colonic Transendoscopic Enteral Tubing Combined With Washed Microbiota Transplantation for Iron Deficiency:A Double-blind Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Iron Deficiency Anemia in Childbirth

Interventions

Type	Name	Description
DRUG	Ferrous Lactate	The injection solution was 3 ferrous lactate (10ml:0.1g iron) mixed with 20ml saline.
DRUG	Iron sucrose	The injection was 3 shots of ferrous lactate (5ml:100mg iron) mixed with 35ml saline.
DRUG	0.9% NaCl solution	The same volume and color as Iron sucrose.

Timeline

• Start date: 2024-07-25
• Primary completion: 2026-01-01
• Completion: 2026-06-01
• First posted: 2024-07-05
• Last updated: 2024-07-22

Locations

1 site across 1 country: China