Regulation of Vitamin D Metabolism by Washed Microbiota Transplantation in Patients With IBD

NCT04989374 | Unknown DMC

• 1 other identifier: WMT-CN-160301
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 25(OH)D in IBD patients before and after treatment

Conditions

IBD

Keywords

IBD; vitaminD; WMT; microbiota

Outcome Measures

Primary Outcomes (1)

• Changes of vitamin D levels in IBD patients after FMT treatment

  After WMT treatment, the level of vitamin d in IBD patients increased

  3 months

Study Arms (4)

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

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• IBD patients aged 16-65years

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

The Secon affiliated hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 28856738 BACKGROUND

• Pittayanon 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.

  PMID: 30940523 BACKGROUND

• Ni 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.

  PMID: 28743984 BACKGROUND

• Kim 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.

  PMID: 34017060 BACKGROUND

• Cui 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.

  PMID: 25168749 BACKGROUND

• Zhang 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.

  PMID: 31919742 BACKGROUND

• Lopez-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.

  PMID: 31083541 BACKGROUND

• Fletcher 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.

  PMID: 31067701 BACKGROUND

• Thomas 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.

  PMID: 33244003 BACKGROUND

• Jones 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.

  PMID: 23609838 BACKGROUND

Central Study Contacts

Faming Zhang, MD,PHD

CONTACT

086-25-58509883; fzhang@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 4, 2021
• Study Start: March 1, 2016
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: November 8, 2021

Record last verified: 2021-06

Locations

CN (1)