Iron Administration Via Colonic TET Combined With WMT for ID

Nanjing Medical University

Status and phase: Not yet enrolling; Phase 2

Conditions: Iron Deficiency Anemia in Childbirth

Treatments: Drug: 0.9% NaCl solution; Drug: Ferrous Lactate; Drug: Iron sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT06487299

TET- RCT-Fe

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups, including a placebo group

Ferrous Lactate

Experimental group

Description:

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.

Treatment:

Drug: Ferrous Lactate

Iron Sucrose

Active Comparator group

Description:

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.

Treatment:

Drug: Iron sucrose

Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: 0.9% NaCl solution