Clinical trial NCT03590418: Microbial Diversity of Small Bowel Stoma Effluent and Colonic Faeces
Official title: Intestinal Microbial Diversity of Small Bowel Stoma Effluent and Colonic Feces of Children With Short Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intestinal Failure
Keywords: Intestinal failure
Microbiota
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Municipal Science and Technology Commission
name: National Natural Science Foundation of China
First posted: 2018-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Microbiota diversity and composition clarified by 16s rRNA sequencing
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
Study officials:
References:
citation: 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.
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.
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.
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.