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

NCT02699320 | Completed DMC

• 1 other identifier: XH-16-001
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Short Bowel Syndrome; Complications

Keywords

Short bowel syndrome; Intestinal microbiota; immune

Outcome Measures

Primary Outcomes (1)

• Microbial structure in SBS infants

  Fecal microbiota were detected by 16S rRNA gene sequencing.

  up to 4 months

Secondary Outcomes (2)

• Metabolism products in SBS infants

  up to 4 months

• Immune biomarkers in SBS infants

  up to 4 months

Study Arms (4)

"Asymptomatic"

"Asymptomatic" meaning patients showed well tolerance to parenteral nutrient (PN) administration and there were no complications occurred within two months (n=7);

Other: Complications

CLABSI

with 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)

Other: Complications

PNALD

with parenteral nutrient associated liver disease (PNALD), meaning SBS patients showed elevated liver enzymes and bilirubin (n=14).

Other: Complications

healthy controls

Seven healthy infants who had added complementary were served as controls (n=7).

Other: Complications

Interventions

Complications OTHER

Not involved

"Asymptomatic"; CLABSI; PNALD; healthy controls

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Infants with short bowel syndrome

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ethics Committee of Xinhua Hospital

Shanghai, Shanghai Municipality, 200092, China

Location

Related Publications (27)

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MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guangyu Chen, PhD

  Shanghai Municipal Science and Technology Commission

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD.

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: March 4, 2016
• Study Start: June 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)