Iron Administration Via Colonic TET Combined With WMT for ID

NCT06487299 | Not Yet Recruiting Phase 2

• 1 other identifier: TET- RCT-Fe
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia in Childbirth

Keywords

Iron; Transendoscopic enteral tubing; Washed Microbiota Transplantation; iron deficiency

Outcome Measures

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.

  Baseline; Day 4

Secondary Outcomes (1)

• Serum ferritin levels

  Baseline; Day 4

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Baseline; Day 4

Study Arms (3)

Ferrous Lactate

EXPERIMENTAL

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.

Drug: Ferrous Lactate

Iron Sucrose

ACTIVE COMPARATOR

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.

Drug: Iron sucrose

Saline

PLACEBO COMPARATOR

0.9% sodium chloride is administered via the colon as an injectable solution at a dose of 50ml per day for 3 days.

Drug: 0.9% NaCl solution

Interventions

Ferrous Lactate DRUG

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

Also known as: PURAMEX(R)

Ferrous Lactate

Iron sucrose DRUG

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

Also known as: Iron saccharate

Iron Sucrose

0.9% NaCl solution DRUG

The same volume and color as Iron sucrose.

Also known as: saline (medicine)

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ferritin ≤30 μg/L;
• feasible colonic TET placement (cephalic end in the ileocecal region);
• completion of 3 WMT sessions.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, China

Location

Related Publications (4)

• Wu J, Lu AD, Zhang LP, Zuo YX, Jia YP. [Study of clinical outcome and prognosis in pediatric core binding factor-acute myeloid leukemia]. Zhonghua Xue Ye Xue Za Zhi. 2019 Jan 14;40(1):52-57. doi: 10.3760/cma.j.issn.0253-2727.2019.01.010. Chinese.

  PMID: 30704229 BACKGROUND

• Minor EA, Kupec JT, Nickerson AJ, Narayanan K, Rajendran VM. Increased DMT1 and FPN1 expression with enhanced iron absorption in ulcerative colitis human colon. Am J Physiol Cell Physiol. 2020 Feb 1;318(2):C263-C271. doi: 10.1152/ajpcell.00128.2019. Epub 2019 Nov 13.

  PMID: 31721611 BACKGROUND

• Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.

  PMID: 27556065 BACKGROUND

• Lu G, Wang W, Li P, Wen Q, Cui B, Zhang F. Washed preparation of faecal microbiota changes the transplantation related safety, quantitative method and delivery. Microb Biotechnol. 2022 Sep;15(9):2439-2449. doi: 10.1111/1751-7915.14074. Epub 2022 May 16.

  PMID: 35576458 BACKGROUND

MeSH Terms

Conditions

Iron Deficiencies

Interventions

ferrous lactate; Ferric Oxide, Saccharated; Saline Solution; Sodium Chloride; Dosage Forms

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Faming Faming, PhD

  The Second Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faming Faming, PhD

CONTACT

02558509670; fzhang@njmu.edu.cn

Bota Cui

CONTACT

02558509883; cuibota@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Gastroenterology

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: July 25, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)