Intestinal FailureNCT03590418
Microbial Diversity of Small Bowel Stoma Effluent and Colonic Faeces
An observational study of Intestinal Failure, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 1 month to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Failure
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2016to 1 Jun 2020
- 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 1 month to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Hospitalized patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Wei Cai, MD, PhD contact
China1 site, 1 recruiting
- Recruiting
Shanghai Xinhua Hospital, affiliated to Shanghai Jiao Tong University, School of Medicine
Shanghai
Wei Cai, MD, PhD
About this study
Official title: Intestinal Microbial Diversity of Small Bowel Stoma Effluent and Colonic Feces of Children With Short Bowel Syndrome
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.
- Conditions
- Intestinal Failure
- Keywords
- Intestinal failure, Microbiota
- Medical subject headings
- Intestinal Failure
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 |
|---|---|---|
| Intestinal stoma output | No interventions. | |
| Colonic feaces | No interventions. | |
| Healthy Control | No interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start1 Nov 2016
- Primary completion15 Dec 2019 (estimated)
- Study completion1 Jun 2020 (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 Intestinal FailureStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission, National Natural Science Foundation of China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03590418
- Sponsor's protocol ID
- ShanghaiXinhua
- Status last verified
- Nov 2017
- First submitted
- 15 Jun 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25250028Booijink 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.
PubMed 20626454Barrett 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.
PubMed 23349073Huang 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.
PubMed 28425133
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbial Diversity of Small Bowel Stoma Effluent and Colonic Feces of Children With Short Bowel Syndrome
- ClinicalTrials.gov ID
- NCT03590418
- Acronym / sponsor ID
- ShanghaiXinhua
- Conditions
- Intestinal Failure
- Keywords
- Intestinal failure, Microbiota
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission, National Natural Science Foundation of China
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 15 Dec 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 18 Jul 2018 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intestinal stoma output | – | –No interventions. |
| Colonic feaces | – | –No interventions. |
| Healthy Control | – | –No interventions. |
Who may qualify
- Ages
- 1 month to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Hospitalized patients
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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
Microbiota diversity and composition clarified by 16s rRNA sequencing
Time frame: 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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Background: PubMed 25250028Arrieta 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.
- Background: PubMed 20626454Booijink 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.
- Background: PubMed 23349073Barrett 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.
- Background: PubMed 28425133Huang 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.
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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.
Wei Cai, MD, PhD contact
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 Intestinal Failure, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 2 inclusion and 1 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 15 Feb 2019. 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 Wei Cai, MD, PhD (caiw204@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota diversity and composition clarified by 16s rRNA sequencing (time frame: 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). 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 NCT03590418, 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 15 Feb 2019.