Iron Administration Via Colonic TET Combined With WMT for ID

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Second Hospital of Nanjing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ferritin ≤30 μg/L;

feasible colonic TET placement (cephalic end in the ileocecal region);

completion of 3 WMT sessions.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ferrous Lactate

    Drug

    The injection solution was 3 ferrous lactate (10ml:0.1g iron) mixed with 20ml saline.

  • Iron sucrose

    Drug

    The injection was 3 shots of ferrous lactate (5ml:100mg iron) mixed with 35ml saline.

  • 0.9% NaCl solution

    Drug

    The same volume and color as Iron sucrose.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Ferrous LactateExperimental treatment 1 intervention
Group B: Iron SucroseActive comparator 1 intervention
Group C: SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reticulocyte haemoglobin values in blood

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

Secondary outcomes

1

Serum ferritin levels

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

Other outcomes

1

Incidence of Treatment-Emergent Adverse Events

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.

Time frame
Baseline; Day 4

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: