Iron Administration Via Colonic TET Combined With WMT for ID

Phase 2

Not yet recruiting

• Conditions: Iron Deficiency Anemia in Childbirth
• Interventions: Drug: 0.9% NaCl solution; Drug: Ferrous Lactate; Drug: Iron sucrose

• Registration Number: NCT06487299
• Lead Sponsor: The Second Hospital of Nanjing Medical University

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 Timeline

• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Status Verified: 2024-07
• Study First Posted: 2024-07-05
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22
• Study Start: 2024-07-25
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline	0.9% NaCl solution	0.9% sodium chloride is administered via the colon as an injectable solution at a dose of 50ml per day for 3 days.
Ferrous Lactate	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.
Iron Sucrose	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China