IBDNCT04989374
Regulation of Vitamin D Metabolism by Washed Microbiota Transplantation in Patients With IBD
An observational study of IBD, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
WMT could effectively induce clinical response and maintain remission in patients with Inflammatory bowel disease (IBD). VD maintains gut microbiota and gut microbiota alter intestinal vitamin D metabolism (VDM),The aim of this study was to evaluate the effect of WMT on VD metabolism by measuring the level of serum… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- IBD
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2016to 30 Dec 2021
- Phase
- Observational
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients with UC or CD were recruited from the Second Affiliated Hospital of Nanjing Medical University between March 2016 and June 2021
Who may be able to join
- IBD patients aged 16-65years
Who cannot join
- previous history of partial small bowel resection;
- Abnormal thyroid and parathyroid function;
- Complicated with complicated intestinal fistula and severe infection and treated with antibiotics
- Women during pregnancy, lactation and oral contraceptives.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Secon affiliated hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Faming, MD, 862558509885, fzhang@njmu.edu.cn
About this study
Official title: Regulation of Vitamin D Metabolism by Washed Microbiota Transplantation in Patients With Inflammatory Bowel Disease
WMT could effectively induce clinical response and maintain remission in patients with Inflammatory bowel disease (IBD). VD maintains gut microbiota and gut microbiota alter intestinal vitamin D metabolism (VDM),The aim of this study was to evaluate the effect of WMT on VD metabolism by measuring the level of serum 25(OH)D in IBD patients before and after treatment
Read the detailed description
Inflammatory bowel disease (IBD) is a chronic, relapsing disorder that is represented by Crohn's disease (CD) and Ulcerative colitis (UC), the pathogenesis of IBD is not completely understood, but it is now acknowledged that it is related to intestinal microbiota. The gut microbiota is a central regulator of host metabolism, More and more evidences show that the gut microbiota plays an important physiological role in the pathogenesis of a variety of human metabolic, immune and neurological diseases, including IBD. Fecal microbiota transplantation (FMT) transplants the gut microbiota of healthy donors into the patients' intestines, This is an effective strategy to restore the intestinal microbiota and it is also a hot research topic in recent years. Our previous studies and other studies have proved that FMT could effectively induce clinical response and maintain remission in patients with IBD. Washed microbiota transplantation (WMT) is a fecal bacteria transplantation based on Intelligent fecal bacteria separation system and strict quality control of washing process, It is a new stage of FMT development, our group have proved that WMT is safer, more precise and more quality-controllable than the crude FMT by manual.
Vitamin D(VD) has been shown to have multifaced effects on the skeletal environment,immune system and infection. A number of diseases, including tumors, Type I diabetes, IBD and autoimmune diseases are associated with VD deficiency, VD could have an important role in the prevention and possible treatment of these conditions. Several studies have shown that intestinal microbiota is closely related to VD，VD maintains gut microbiota and gut microbiota alter intestinal vitamin D metabolism (VDM). A clinical trial shows that probiotics supplementation can change the level of 25 hydroxyvitaminD(25(OH)D). Serum 25(OH)D correlates with overall storage of VD, which is the preferred clinical measure to assess VD sufficiency. The aim of this study was to evaluate the effect of WMT on VD metabolism by measuring the level of serum 25(OH)D in IBD patients before and after treatment
- Conditions
- IBD
- Keywords
- IBD, vitaminD, WMT, microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CD patients treated with WMT | the gastrointestinal experts decided the treatment plan according to the patient's condition and the patient's wishes, these CD patients treated with WMT | |
| CD patients treated without WMT | the gastrointestinal experts decided the treatment plan according to the patient's condition and the patient's wishes, these CD patients treated without WMT | |
| UC patients treated with WMT | the gastrointestinal experts decided the treatment plan according to the patient's condition and the patient's wishes, these UC patients treated with WMT | |
| UC patients treated without WMT | the gastrointestinal experts decided the treatment plan according to the patient's condition and the patient's wishes, these UC patients treated without WMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of vitamin D levels in IBD patients after FMT treatment
After WMT treatment, the level of vitamin d in IBD patients increased
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Mar 2016
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for IBDStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989374
- Sponsor's protocol ID
- WMT-CN-160301
- Status last verified
- Jun 2021
- First submitted
- 22 Jul 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pickard JM, Zeng MY, Caruso R, Nunez G. Gut microbiota: Role in pathogen colonization, immune responses, and inflammatory disease. Immunol Rev. 2017 Sep;279(1):70-89. doi: 10.1111/imr.12567.
PubMed 28856738Pittayanon R, Lau JT, Yuan Y, Leontiadis GI, Tse F, Surette M, Moayyedi P. Gut Microbiota in Patients With Irritable Bowel Syndrome-A Systematic Review. Gastroenterology. 2019 Jul;157(1):97-108. doi: 10.1053/j.gastro.2019.03.049. Epub 2019 Mar 30.
PubMed 30940523Ni J, Wu GD, Albenberg L, Tomov VT. Gut microbiota and IBD: causation or correlation? Nat Rev Gastroenterol Hepatol. 2017 Oct;14(10):573-584. doi: 10.1038/nrgastro.2017.88. Epub 2017 Jul 19.
PubMed 28743984Kim JH, Kim K, Kim W. Gut microbiota restoration through fecal microbiota transplantation: a new atopic dermatitis therapy. Exp Mol Med. 2021 May;53(5):907-916. doi: 10.1038/s12276-021-00627-6. Epub 2021 May 20.
PubMed 34017060Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.
PubMed 25168749Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.
PubMed 31919742Lopez-Munoz P, Beltran B, Saez-Gonzalez E, Alba A, Nos P, Iborra M. Influence of Vitamin D Deficiency on Inflammatory Markers and Clinical Disease Activity in IBD Patients. Nutrients. 2019 May 11;11(5):1059. doi: 10.3390/nu11051059.
PubMed 31083541Fletcher J, Cooper SC, Ghosh S, Hewison M. The Role of Vitamin D in Inflammatory Bowel Disease: Mechanism to Management. Nutrients. 2019 May 7;11(5):1019. doi: 10.3390/nu11051019.
PubMed 31067701Thomas RL, Jiang L, Adams JS, Xu ZZ, Shen J, Janssen S, Ackermann G, Vanderschueren D, Pauwels S, Knight R, Orwoll ES, Kado DM. Vitamin D metabolites and the gut microbiome in older men. Nat Commun. 2020 Nov 26;11(1):5997. doi: 10.1038/s41467-020-19793-8.
PubMed 33244003Jones ML, Martoni CJ, Prakash S. Oral supplementation with probiotic L. reuteri NCIMB 30242 increases mean circulating 25-hydroxyvitamin D: a post hoc analysis of a randomized controlled trial. J Clin Endocrinol Metab. 2013 Jul;98(7):2944-51. doi: 10.1210/jc.2012-4262. Epub 2013 Apr 22.
PubMed 23609838
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Vitamin D Metabolism by Washed Microbiota Transplantation in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT04989374
- Acronym / sponsor ID
- WMT-CN-160301
- Conditions
- IBD
- Keywords
- IBD, vitaminD, WMT, microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 4 Aug 2021 (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.
WMT could effectively induce clinical response and maintain remission in patients with Inflammatory bowel disease (IBD). VD maintains gut microbiota and gut microbiota alter intestinal vitamin D metabolism (VDM),The aim of this study was to evaluate the effect of WMT on VD metabolism by measuring the level of serum 25(OH)D in IBD patients before and after treatment
Detailed description
Inflammatory bowel disease (IBD) is a chronic, relapsing disorder that is represented by Crohn's disease (CD) and Ulcerative colitis (UC), the pathogenesis of IBD is not completely understood, but it is now acknowledged that it is related to intestinal microbiota. The gut microbiota is a central regulator of host metabolism, More and more evidences show that the gut microbiota plays an important physiological role in the pathogenesis of a variety of human metabolic, immune and neurological diseases, including IBD. Fecal microbiota transplantation (FMT) transplants the gut microbiota of healthy donors into the patients' intestines, This is an effective strategy to restore the intestinal microbiota and it is also a hot research topic in recent years. Our previous studies and other studies have proved that FMT could effectively induce clinical response and maintain remission in patients with IBD. Washed microbiota transplantation (WMT) is a fecal bacteria transplantation based on Intelligent fecal bacteria separation system and strict quality control of washing process, It is a new stage of FMT development, our group have proved that WMT is safer, more precise and more quality-controllable than the crude FMT by manual.
Vitamin D(VD) has been shown to have multifaced effects on the skeletal environment,immune system and infection. A number of diseases, including tumors, Type I diabetes, IBD and autoimmune diseases are associated with VD deficiency, VD could have an important role in the prevention and possible treatment of these conditions. Several studies have shown that intestinal microbiota is closely related to VD，VD maintains gut microbiota and gut microbiota alter intestinal vitamin D metabolism (VDM). A clinical trial shows that probiotics supplementation can change the level of 25 hydroxyvitaminD(25(OH)D). Serum 25(OH)D correlates with overall storage of VD, which is the preferred clinical measure to assess VD sufficiency. The aim of this study was to evaluate the effect of WMT on VD metabolism by measuring the level of serum 25(OH)D in IBD patients before and after treatment
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CD patients treated with WMT | – | –the gastrointestinal experts decided the treatment plan according to the patient's condition and the patient's wishes, these CD patients treated with WMT |
| CD patients treated without WMT | – | –the gastrointestinal experts decided the treatment plan according to the patient's condition and the patient's wishes, these CD patients treated without WMT |
| UC patients treated with WMT | – | –the gastrointestinal experts decided the treatment plan according to the patient's condition and the patient's wishes, these UC patients treated with WMT |
| UC patients treated without WMT | – | –the gastrointestinal experts decided the treatment plan according to the patient's condition and the patient's wishes, these UC patients treated without WMT |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients with UC or CD were recruited from the Second Affiliated Hospital of Nanjing Medical University between March 2016 and June 2021
Key inclusion criteria (1 listed)
- IBD patients aged 16-65years
Key exclusion criteria (4 listed)
- previous history of partial small bowel resection;
- Abnormal thyroid and parathyroid function;
- Complicated with complicated intestinal fistula and severe infection and treated with antibiotics
- Women during pregnancy, lactation and oral contraceptives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes of vitamin D levels in IBD patients after FMT treatment
Time frame: 3 months
After WMT treatment, the level of vitamin d in IBD patients increased
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Background: PubMed 28856738Pickard JM, Zeng MY, Caruso R, Nunez G. Gut microbiota: Role in pathogen colonization, immune responses, and inflammatory disease. Immunol Rev. 2017 Sep;279(1):70-89. doi: 10.1111/imr.12567.
- Background: PubMed 30940523Pittayanon R, Lau JT, Yuan Y, Leontiadis GI, Tse F, Surette M, Moayyedi P. Gut Microbiota in Patients With Irritable Bowel Syndrome-A Systematic Review. Gastroenterology. 2019 Jul;157(1):97-108. doi: 10.1053/j.gastro.2019.03.049. Epub 2019 Mar 30.
- Background: PubMed 28743984Ni J, Wu GD, Albenberg L, Tomov VT. Gut microbiota and IBD: causation or correlation? Nat Rev Gastroenterol Hepatol. 2017 Oct;14(10):573-584. doi: 10.1038/nrgastro.2017.88. Epub 2017 Jul 19.
- Background: PubMed 34017060Kim JH, Kim K, Kim W. Gut microbiota restoration through fecal microbiota transplantation: a new atopic dermatitis therapy. Exp Mol Med. 2021 May;53(5):907-916. doi: 10.1038/s12276-021-00627-6. Epub 2021 May 20.
- Background: PubMed 25168749Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.
- Background: PubMed 31919742Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.
- Background: PubMed 31083541Lopez-Munoz P, Beltran B, Saez-Gonzalez E, Alba A, Nos P, Iborra M. Influence of Vitamin D Deficiency on Inflammatory Markers and Clinical Disease Activity in IBD Patients. Nutrients. 2019 May 11;11(5):1059. doi: 10.3390/nu11051059.
- Background: PubMed 31067701Fletcher J, Cooper SC, Ghosh S, Hewison M. The Role of Vitamin D in Inflammatory Bowel Disease: Mechanism to Management. Nutrients. 2019 May 7;11(5):1019. doi: 10.3390/nu11051019.
- Background: PubMed 33244003Thomas RL, Jiang L, Adams JS, Xu ZZ, Shen J, Janssen S, Ackermann G, Vanderschueren D, Pauwels S, Knight R, Orwoll ES, Kado DM. Vitamin D metabolites and the gut microbiome in older men. Nat Commun. 2020 Nov 26;11(1):5997. doi: 10.1038/s41467-020-19793-8.
- Background: PubMed 23609838Jones ML, Martoni CJ, Prakash S. Oral supplementation with probiotic L. reuteri NCIMB 30242 increases mean circulating 25-hydroxyvitamin D: a post hoc analysis of a randomized controlled trial. J Clin Endocrinol Metab. 2013 Jul;98(7):2944-51. doi: 10.1210/jc.2012-4262. Epub 2013 Apr 22.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD, 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 1 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 8 Nov 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Zhang, MD,PHD (086-25-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of vitamin D levels in IBD patients after FMT treatment (time frame: 3 months). 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 NCT04989374, which also lists 10 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 8 Nov 2021.