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Short Bowel SyndromeMSBSNCT02699320

Intestinal Microbial Dysbiosis in Chinese Infants With Short Bowel Syndrome With Different Complications

An observational study of Short Bowel Syndrome and Complications, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There are no reports involved the intestinal microbiota from Chinese infants with short bowel syndrome (SBS) under different clinical status. Alterations in the microbiota are closely correlated with the bile acids and short chain fatty acids metabolism as well as the intestinal immunity. Read more about this study

Who is it for?
Ages Up to 1 year
Conditions the study is for
Short Bowel Syndrome, Complications
What is being tested?
Complications
How many people
33 participants
Where
1 siteChina
Study dates
Jun 2015to Jan 2016
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 Up to 1 year
  • All sexes
  • No healthy volunteers
  • Child

Study population: 18 infants diagnosed with SBS were enrolled from Digestion and Nutrition Division at Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine.

Who may be able to join

  • Infants with short bowel syndrome

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ethics Committee of Xinhua Hospital

    Shanghai, Shanghai Municipality, 200092

Other trials in China

About this study

Official title: Multi-center Clinical Research About Standard Diagnosis and Treatment of Neonate Severe Digestive System Malformation

There are no reports involved the intestinal microbiota from Chinese infants with short bowel syndrome (SBS) under different clinical status. Alterations in the microbiota are closely correlated with the bile acids and short chain fatty acids metabolism as well as the intestinal immunity. A relatively comprehensive profile composed of microbial structure, microbial metabolism products and immune biomarkers in SBS infants may facilitate a better therapy strategy to complications occurred in SBS children.

Read the detailed description

The investigators totally collected 26 fecal samples from 18 infants diagnosed with SBS during parenteral nutrition administration, and these samples were divided into three groups according to complications of enrolled patients at sampling time: asymptomatic group, central catheter-related blood stream infections group and liver injury group. 7 healthy infants with supplementary food were enrolled as control. Fecal microbiota, sIgA and calprotectin, bile acids and short chain fatty acids were also detected by 16S ribosomal ribonucleic acid (rRNA) gene sequencing, enzyme-linked immunosorbent assay and liquid/gas chromatography.

Being tested
Complications
Keywords
Short bowel syndrome, Intestinal microbiota, immune
Medical subject headings
Short Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ComplicationsOther

    Not involved

Study groups in NCT02699320
Study groupRoleWhat they receive
"Asymptomatic""Asymptomatic" meaning patients showed well tolerance to parenteral nutrient (PN) administration and there were no complications occurred within two months (n=7);
Receives: Other: Complications
CLABSIwith central catheter-related blood stream infections (CLABSI) meaning patients had fever, increased neutrophils, documented positive catheter blood culture but exclude other source of infection (n=5)
Receives: Other: Complications
PNALDwith parenteral nutrient associated liver disease (PNALD), meaning SBS patients showed elevated liver enzymes and bilirubin (n=14).
Receives: Other: Complications
healthy controlsSeven healthy infants who had added complementary were served as controls (n=7).
Receives: Other: Complications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Microbial structure in SBS infants

    Fecal microbiota were detected by 16S rRNA gene sequencing.

    Measured: up to 4 months

Secondary outcomes (2)

  1. Metabolism products in SBS infants

    Bile acids and short chain fatty acids were detected by liquid/gas chromatography.

    Measured: up to 4 months

  2. Immune biomarkers in SBS infants

    Secretary IgA and calprotectin were detected by enzyme-linked immunosorbent assay.

    Measured: up to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2016 (estimated)
  2. Study startJun 2015
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

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
Retrospective
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02699320
Sponsor's protocol ID
XH-16-001
Acronym
MSBS
Status last verified
Feb 2016
First submitted
2 Feb 2016
Last updated
4 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Vanderhoof JA, Langnas AN. Short-bowel syndrome in children and adults. Gastroenterology. 1997 Nov;113(5):1767-78. doi: 10.1053/gast.1997.v113.pm9352883.

    PubMed 9352883

  • Wales PW, de Silva N, Kim J, Lecce L, To T, Moore A. Neonatal short bowel syndrome: population-based estimates of incidence and mortality rates. J Pediatr Surg. 2004 May;39(5):690-5. doi: 10.1016/j.jpedsurg.2004.01.036.

    PubMed 15137001

  • Howard L, Ashley C. Management of complications in patients receiving home parenteral nutrition. Gastroenterology. 2003 May;124(6):1651-61. doi: 10.1016/s0016-5085(03)00326-3.

    PubMed 12761723

  • Bull MJ, Plummer NT. Part 1: The Human Gut Microbiome in Health and Disease. Integr Med (Encinitas). 2014 Dec;13(6):17-22.

    PubMed 26770121

  • Caldarini MI, Pons S, D'Agostino D, DePaula JA, Greco G, Negri G, Ascione A, Bustos D. Abnormal fecal flora in a patient with short bowel syndrome. An in vitro study on effect of pH on D-lactic acid production. Dig Dis Sci. 1996 Aug;41(8):1649-52. doi: 10.1007/BF02087915.

    PubMed 8769294

  • Sondheimer JM, Asturias E, Cadnapaphornchai M. Infection and cholestasis in neonates with intestinal resection and long-term parenteral nutrition. J Pediatr Gastroenterol Nutr. 1998 Aug;27(2):131-7. doi: 10.1097/00005176-199808000-00001.

    PubMed 9702641

  • Winter SE, Baumler AJ. Dysbiosis in the inflamed intestine: chance favors the prepared microbe. Gut Microbes. 2014 Jan-Feb;5(1):71-3. doi: 10.4161/gmic.27129. Epub 2014 Jan 29.

    PubMed 24637596

  • Halmos T, Suba I. [Physiological patterns of intestinal microbiota. The role of dysbacteriosis in obesity, insulin resistance, diabetes and metabolic syndrome]. Orv Hetil. 2016 Jan 3;157(1):13-22. doi: 10.1556/650.2015.30296. Hungarian.

    PubMed 26708682

  • Furtado Ede C, Marchini JS, Fonseca CK, Coelho PS, Menegueti MG, Auxiliadora-Martins M, Basile-Filho A, Suen VM. Cyclic parenteral nutrition does not change the intestinal microbiota in patients with short bowel syndrome. Acta Cir Bras. 2013;28 Suppl 1:26-32. doi: 10.1590/s0102-86502013001300006.

    PubMed 23381820

  • Joly F, Mayeur C, Bruneau A, Noordine ML, Meylheuc T, Langella P, Messing B, Duee PH, Cherbuy C, Thomas M. Drastic changes in fecal and mucosa-associated microbiota in adult patients with short bowel syndrome. Biochimie. 2010 Jul;92(7):753-61. doi: 10.1016/j.biochi.2010.02.015. Epub 2010 Feb 19.

    PubMed 20172013

  • Engstrand Lilja H, Wefer H, Nystrom N, Finkel Y, Engstrand L. Intestinal dysbiosis in children with short bowel syndrome is associated with impaired outcome. Microbiome. 2015 May 4;3:18. doi: 10.1186/s40168-015-0084-7. eCollection 2015.

    PubMed 25941569

  • Davidovics ZH, Carter BA, Luna RA, Hollister EB, Shulman RJ, Versalovic J. The Fecal Microbiome in Pediatric Patients With Short Bowel Syndrome. JPEN J Parenter Enteral Nutr. 2016 Nov;40(8):1106-1113. doi: 10.1177/0148607115591216. Epub 2015 Jun 9.

    PubMed 26059898

  • Bharadwaj S, Gohel T, Deen OJ, DeChicco R, Shatnawei A. Fish oil-based lipid emulsion: current updates on a promising novel therapy for the management of parenteral nutrition-associated liver disease. Gastroenterol Rep (Oxf). 2015 May;3(2):110-4. doi: 10.1093/gastro/gov011. Epub 2015 Apr 8.

    PubMed 25858884

  • Raphael BP, Mitchell PD, Finkton D, Jiang H, Jaksic T, Duggan C. Necrotizing Enterocolitis and Central Line Associated Blood Stream Infection Are Predictors of Growth Outcomes in Infants with Short Bowel Syndrome. J Pediatr. 2015 Jul;167(1):35-40.e1. doi: 10.1016/j.jpeds.2015.02.053. Epub 2015 Apr 1.

    PubMed 25841540

  • Greenberg RG, Moran C, Ulshen M, Smith PB, Benjamin DK Jr, Cohen-Wolkowiez M. Outcomes of catheter-associated infections in pediatric patients with short bowel syndrome. J Pediatr Gastroenterol Nutr. 2010 Apr;50(4):460-2. doi: 10.1097/MPG.0b013e3181b99d07.

    PubMed 20179637

Questions about this trial

What is this clinical trial studying?

An observational study of Short Bowel Syndrome and Complications, 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 4 Mar 2016. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microbial structure in SBS infants (time frame: up to 4 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 NCT02699320, which also lists 27 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 4 Mar 2016.

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