Microbial Diversity of Small Bowel Stoma Effluent and Colonic Faeces

Intestinal Failure Clinical Trial

Official title:

Intestinal Microbial Diversity of Small Bowel Stoma Effluent and Colonic Feces of Children With Short Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03590418
• Other study ID #: ShanghaiXinhua
• Status: Recruiting
• Start date: November 1, 2016
• Est. completion date: June 1, 2020

Study information

• Verified date: November 2017
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Wei Cai, MD, PhD
• Email: caiw204[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Several studies suggested that dysbacteriosis usually happened in patients with intestinal failure (IF). However, differences of microbiota diversity in small intestine stoma effluents and colonic faeces were rarely studies. Thus this study is aimed to investigate the microbiota compositions and differences of output of small intestine stoma and colon in pediatric IF patients. Fecal samples from IF patients. Each patient received fistula closure in our centre and fecal samples from both small intestinal stoma and colon were collected. Fecal microbial compositions were determined by high-throughput sequencing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month to 3 Years

Eligibility

Inclusion Criteria:

• Patients with intestinal failure. Patients showed good tolerance to parenteral and enteral nutrition administration. Proportion of enteral nutrition is more than 80%.

Stool output maintained at less than 50mL/kg/day. No complications occurred for at least 1 week.

Exclusion Criteria:

• Patients depend mainly on parenteral nutrition. Symptoms like fever, abdominal distention and diarrhea. Complications like parenteral nutrition-associated liver disease, pneumonia and catheter related infection.

Related Conditions & MeSH terms

• Intestinal Failure

Locations

Country	Name	City	State
China	Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	National Natural Science Foundation of China, Shanghai Municipal Science and Technology Commission

Country where clinical trial is conducted

China, 

References & Publications (4)

Arrieta MC, Stiemsma LT, Amenyogbe N, Brown EM, Finlay B. The intestinal microbiome in early life: health and disease. Front Immunol. 2014 Sep 5;5:427. doi: 10.3389/fimmu.2014.00427. eCollection 2014. Review. — View Citation

Barrett E, Guinane CM, Ryan CA, Dempsey EM, Murphy BP, O'Toole PW, Fitzgerald GF, Cotter PD, Ross RP, Stanton C. Microbiota diversity and stability of the preterm neonatal ileum and colon of two infants. Microbiologyopen. 2013 Apr;2(2):215-25. doi: 10.1002/mbo3.64. Epub 2013 Jan 24. — View Citation

Booijink CC, El-Aidy S, Rajilic-Stojanovic M, Heilig HG, Troost FJ, Smidt H, Kleerebezem M, De Vos WM, Zoetendal EG. High temporal and inter-individual variation detected in the human ileal microbiota. Environ Microbiol. 2010 Dec;12(12):3213-27. doi: 10.1111/j.1462-2920.2010.02294.x. — View Citation

Huang Y, Guo F, Li Y, Wang J, Li J. Fecal microbiota signatures of adult patients with different types of short bowel syndrome. J Gastroenterol Hepatol. 2017 Dec;32(12):1949-1957. doi: 10.1111/jgh.13806. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiota diversity and composition clarified by 16s rRNA sequencing	DNA of gut microbiota will be extracted. Then purified DNA amplicons are pooled in equimolar and paired-end sequenced (2 × 250) on an Illumina MiSeq platform. Raw Fastq files will be de-multiplexed, quality-filtered using QIIME (version 1.17). Operational taxonomic units (OTUs) will be next clustered with 97% similarity cutoff using UPARSE version 7.1 (http://drive5.com/ uparse/) and chimeric sequences will be identified and removed using UCHIME (http://drive5.com/index.htm). The phylogenetic affiliation of each 16S rRNA gene sequence is analyzed by RDP Classifier (http:// rdp.cme.msu.edu/) against the silva (SSU117/119)16S rRNA. Sobs index and Chao index will be used to evaluate the microbiota diversity. Microbiota composition will be identified on different levels including phylum, family and genus.	1)Samples collection: one day before patients are discharged from hospital; 2)DNA extraction: within one week after samples collection; 3)Sequencing and data analyzing: within one month after DNA extract