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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Iron Deficiency Anemia in Childbirth
• Intervention / Treatment: Drug: Ferrous Lactate; Drug: Iron sucrose; Drug: 0.9% NaCl solution

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bota Cui; Phone Number: 02558509883; Email: cuibota@njmu.edu.cn
• Study Contact Backup: Name: Faming Faming, PhD; Phone Number: 02558509670; Email: fzhang@njmu.edu.cn

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Ferrous Lactate; The injection solution was 3 ferrous lactate (10ml:0.1g iron) mixed with 20ml saline.; Other Names: PURAMEX(R)
Active Comparator: 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.	Drug: Iron sucrose; The injection was 3 shots of ferrous lactate (5ml:100mg iron) mixed with 35ml saline.; Other Names: Iron saccharate
Placebo Comparator: Saline; 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; The same volume and color as Iron sucrose.; Other Names: saline (medicine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum ferritin levels	To compare the level of ferritin in the serum before and after administration of iron lactate, iron sucrose and saline.	Baseline; Day 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline; Day 4

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University
• Investigators: Principal Investigator: Faming Faming, PhD, The Second Hospital of Nanjing Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): July 25, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Iron; iron deficiency; Washed Microbiota Transplantation; Transendoscopic enteral tubing
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Iron Deficiencies; Physiological Effects of Drugs; Trace Elements; Micronutrients; Hematinics; Iron; Ferric Oxide, Saccharated
• Other Study ID Numbers: TET- RCT-Fe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No