Iron Deficiency Anemia in ChildbirthPhase 2NCT06487299
Iron Administration Via Colonic TET Combined With WMT for ID
A Phase 2 study testing Ferrous Lactate, Iron sucrose and 0.9% NaCl solution in people with Iron Deficiency Anemia in Childbirth, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Deficiency Anemia in Childbirth
- What is being tested?
- Ferrous Lactate, Iron sucrose and 0.9% NaCl solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2024to 1 Jun 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ferritin ≤30 μg/L;
- feasible colonic TET placement (cephalic end in the ileocecal region);
- completion of 3 WMT sessions.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Microbiota Medicine & Medical Centre for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
About this study
Official title: 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.
Read the 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.
- Conditions
- Iron Deficiency Anemia in Childbirth
- Being tested
- Ferrous Lactate, Iron sucrose, 0.9% NaCl solution
- Keywords
- Iron, Transendoscopic enteral tubing, Washed Microbiota Transplantation, iron deficiency
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous LactateDrug
Also called PURAMEX(R)
The injection solution was 3 ferrous lactate (10ml:0.1g iron) mixed with 20ml saline.
Iron sucroseDrug
Also called Iron saccharate
The injection was 3 shots of ferrous lactate (5ml:100mg iron) mixed with 35ml saline.
0.9% NaCl solutionDrug
Also called saline (medicine)
The same volume and color as Iron sucrose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: 0.9% NaCl solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; Day 4
Secondary outcomes (1)
Serum ferritin levels
To compare the level of ferritin in the serum before and after administration of iron lactate, iron sucrose and saline.
Measured: Baseline; Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start25 Jul 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia in ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Faming Faming, PhD, Principal investigator, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487299
- Sponsor's protocol ID
- TET- RCT-Fe
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30704229Minor 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.
PubMed 31721611Peng 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.
PubMed 27556065Lu 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.
PubMed 35576458
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Administration Via Colonic Transendoscopic Enteral Tubing Combined With Washed Microbiota Transplantation for Iron Deficiency:A Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06487299
- Acronym / sponsor ID
- TET- RCT-Fe
- Conditions
- Iron Deficiency Anemia in Childbirth
- Keywords
- Iron, Transendoscopic enteral tubing, Washed Microbiota Transplantation, iron deficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 25 Jul 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ferrous Lactate | Experimental | Drug: Ferrous LactateFerrous 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 | Drug: Iron sucroseIron 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 | Drug: 0.9% NaCl solution0.9% sodium chloride is administered via the colon as an injectable solution at a dose of 50ml per day for 3 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ferritin ≤30 μg/L;
- feasible colonic TET placement (cephalic end in the ileocecal region);
- completion of 3 WMT sessions.
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous LactateAlso: PURAMEX(R)The injection solution was 3 ferrous lactate (10ml:0.1g iron) mixed with 20ml saline. | Drug | Ferrous Lactate |
| Iron sucroseAlso: Iron saccharateThe injection was 3 shots of ferrous lactate (5ml:100mg iron) mixed with 35ml saline. | Drug | Iron Sucrose |
| 0.9% NaCl solutionAlso: saline (medicine)The same volume and color as Iron sucrose. | Drug | Saline |
Primary outcome
Reticulocyte haemoglobin values in blood
Time frame: Baseline; Day 4
To compare the level of reticulocyte haemoglobin in the blood before and after administration of iron lactate, iron sucrose and saline.
1 secondary outcome
Serum ferritin levels
Time frame: Baseline; Day 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Background: PubMed 30704229Wu 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.
- Background: PubMed 31721611Minor 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.
- Background: PubMed 27556065Peng 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.
- Background: PubMed 35576458Lu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faming Faming, PhD principal investigator
The Second Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ferrous Lactate, Iron sucrose and 0.9% NaCl solution in people with Iron Deficiency Anemia in Childbirth, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Faming Faming, PhD (02558509670, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reticulocyte haemoglobin values in blood (time frame: Baseline; Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06487299, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.