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NCT02340312 · ClinicalTrials.gov registry record

Functional Dyspepsia Microbiome Study

A clinical trial of Functional Dyspepsia, sponsored by Children's Mercy Hospital Kansas City.

Completed
Registry status
40
Enrollment target
1
Study location

NCT02340312: Completed study of Functional Dyspepsia, sponsored by Children's Mercy Hospital Kansas City.

NCT02340312 is a study of Functional Dyspepsia that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 40 participants, below the 68-participant average among 9 other Functional Dyspepsia trials with a reported enrollment target (41% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02340312, a study of Functional Dyspepsia, has completed, sponsored by Children's Mercy Hospital Kansas City.

COMPLETED
Registry status
40 participants
Enrollment target
1
Study location

Study Summary

Recurrent abdominal pain has long been acknowledged to be the most common chronic pain entities in children. The purpose of this study is to describe the microbiome in children with FD and to explore relationships between the microbiome and postprandial distress syndrome, anxiety scores, and mucosal biomarkers or anxiety. The specific goals of this study are to: 1) Determine the frequencies and relative proportions for specific bacteria or bacteria phyla in children with FD in both duodenal mucosal specimens and stool samples. 2) Determine if the frequencies or proportions of specific bacteria or bacteria phyla differ between children with and without PDS. 3) Determine bi-variate correlations between bacteria/phyla frequency, bacteria/phyla proportions, anxiety scores, and mucosal biomarkers, respectively.

Primary Outcome

Fecal samples and 8 mucosal biopsies (descending duodenum) will be obtained from each subject. Samples will be processed and DNA isolated per standard lab techniques.16S rDNA sequence analysis of microbial communities within patient samples will be analyzed utilizing our HiSeq 1500 rapid run technologies. We will perform 2 X 150 bp paired end sequencing which will give exceptional coverage (reads \> 30,000). We will sequence the V4 region of 16s RNA (E. coli 515-806), which is the method optimiz

Conditions Studied

Interventions

  • PROCEDURE EGD
  • OTHER Collection of Stool Specimens

Study Locations (1)

Missouri

  • The Children's Mercy Hospital - Kansas City

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2015-01
Est. Completion 2018-09

What the finished NCT02340312 record still lists

NCT02340312 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 68-participant average among 9 other Functional Dyspepsia trials with a reported enrollment target (41% lower).

The record links to 1 condition, with Functional Dyspepsia appearing as the primary indexed condition, and to 2 interventions - of which EGD is the first listed.

NCT02340312 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT02340312 about?

NCT02340312 is a clinical study titled "Functional Dyspepsia Microbiome Study". Recurrent abdominal pain has long been acknowledged to be the most common chronic pain entities in children. The purpose of this study is to describe the microbiome in children with FD and to explore relationships between the microbiome and postprandial distress syndrome, anxiety scores, and mucosal...

What is the current status of trial NCT02340312?

This trial is currently completed. The enrollment target is 40 participants. The study started on 2015-01. Estimated completion is 2018-09.

What conditions does trial NCT02340312 study?

This clinical trial studies the following conditions: Functional Dyspepsia.

What interventions are being tested in trial NCT02340312?

The interventions under investigation include: EGD (PROCEDURE), Collection of Stool Specimens (OTHER).

Who is sponsoring clinical trial NCT02340312?

This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02340312 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Functional Dyspepsia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02340312's enrollment target sits among peer trials

40 5th of 9 higher than 4 of 9 other Functional Dyspepsia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Functional Dyspepsia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02340312, the US trial registry maintained by the National Library of Medicine. NCT02340312 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.