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

TET- RCT-Fe

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.

2024-07-01

2026-01-01

2026-06-01

Not yet recruiting

Early phase I

60

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;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2024-07-04