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NCT Number: NCT06487299

Iron Administration Via Colonic TET Combined With WMT for ID

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Ferrous Lactate

Drug

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

Other names: PURAMEX(R)

Iron sucrose

Drug

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

Other names: Iron saccharate

0.9% NaCl solution

Drug

The same volume and color as Iron sucrose.

Other names: saline (medicine)

Primary outcomes

  1. 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

  1. Serum ferritin levels

    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.

Other outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bota Cui

CONTACT

[email protected]

02558509883

Faming Faming, PhD

CONTACT

[email protected]

02558509670

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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