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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous Lactate | Drug | The injection solution was 3 ferrous lactate (10ml:0.1g iron) mixed with 20ml saline. |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Faming Faming, PhD | Contact | 02558509670 | fzhang@njmu.edu.cn | |
| Bota Cui | Contact | 02558509883 | cuibota@njmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Faming Faming, PhD | The Second Hospital of Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30704229 | Background | 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. | |
| 31721611 | 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. |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C101012 | ferrous lactate |
| D000077605 | Ferric Oxide, Saccharated |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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| Iron sucrose | Drug | The injection was 3 shots of ferrous lactate (5ml:100mg iron) mixed with 35ml saline. |
|
|
| 0.9% NaCl solution | Drug | The same volume and color as Iron sucrose. |
|
|
| 27556065 | 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. |
| 35576458 | 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. |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |