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RecruitingNCT07539727Updated Apr 20, 2026

Clinical Value of Intestinal Ultrasound in Predicting Clinical Relapse in Crohn's Disease Patients in Deep Remission: a Multicenter Prospective Observational Study

An observational study in Inflammatory Bowel Diseases, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Nanfang Hospital, Southern Medical University · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
420
Ages
18 Years to 70 Years
Sex
All
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Study summary

Crohn's disease (CD) is a nonspecific chronic inflammatory condition characterized by a protracted course with alternating periods of relapse and remission. Even patients who achieve deep remission remain prone to recurrence and require long-term follow-up. While various monitoring methods are available, endoscopy plays a primary role in the management and diagnosis of CD; however, its relative invasiveness and the need for bowel preparation limit the feasibility of continuous monitoring. In contrast, transabdominal intestinal ultrasound offers advantages such as non-invasiveness, absence of radiation, good patient tolerance, and low cost, making it suitable for long-term monitoring. However, most studies have focused on exploring its concordance with disease activity and endoscopic findings, with only a limited number of studies examining its clinical significance for long-term prognosis.

Therefore, we conducted a multicenter prospective study involving 18 months of follow-up in CD patients who achieved deep remission. Based on the follow-up results, patients were divided into relapse and non-relapse groups. Stratified analysis was performed according to the Montreal classification to compare color Doppler ultrasound parameters between the two groups and within each stratum, and to establish a predictive model.

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Conditions studied

  • Inflammatory Bowel Diseases
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In context

Inflammatory Bowel Diseases

1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 438 are open to participants now.

This study's planned enrollment of 420 is above the median of 139 across 645 observational studies indexed under Inflammatory Bowel Diseases.

Browse Inflammatory Bowel Diseases studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with CD who have achieved clinical remission as assessed by evaluation and mucosal healing as assessed by endoscopy

Inclusion criteria

  • Patients previously diagnosed with Crohn's disease via endoscopy and histopathology at other hospitals or at our institution; patients aged 18-70 years; Complete clinical data and biochemical parameters are available for the week before and after endoscopy, including comprehensive patient demographics and laboratory indicators such as complete blood count, liver function, kidney function, CRP, and ESR; a color Doppler ultrasound of the intestines was performed at our hospital within one week before or after endoscopy, and the relevant records are complete; patients assessed to have achieved deep remission based on endoscopic and other data.

Exclusion criteria

Exclusion Criteria:

  • Patients with concomitant colorectal cancer; patients with severe cardiovascular, respiratory, or urinary dysfunction; pregnant or lactating women; patients younger than 16 or older than 70 years of age; patients who changed their maintenance therapy regimen upon achieving deep remission; patients with incomplete medical records, such as color Doppler ultrasound of the intestines.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
420 participants (estimated)
Target follow-up
18 Months
Patient registry
Yes

Groups and cohorts

  • Relapse Group

    Patients with Crohn's disease who achieved deep remission at baseline but experienced clinical recurrence during the 18-month follow-up period. Their baseline ultrasound parameters will be analyzed to identify risk factors for recurrence.

    Device: Transabdominal Intestinal Ultrasound

  • Non-Relapse Group

    Patients with Crohn's disease who achieved deep remission at baseline and maintained remission without clinical recurrence throughout the 18-month follow-up period. This group serves as the control for comparing ultrasound parameters.

    Device: Transabdominal Intestinal Ultrasound

Interventions

  • DeviceTransabdominal Intestinal Ultrasound

    Transabdominal intestinal ultrasound using color Doppler will be performed to assess bowel wall thickness and vascularity in Crohn's disease patients who have achieved deep remission. This non-invasive imaging modality will be used to monitor patients over an 18-month period to evaluate its ability to predict clinical recurrence.

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What researchers measure

Primary outcomes

  1. Clinical Recurrence of Crohn's Disease

    The proportion of patients who experience clinical recurrence of Crohn's disease during the follow-up period. Clinical recurrence is defined by the return of active disease symptoms requiring a change in medical therapy or endoscopic confirmation of active inflammation.

    Time frame: 18 months after enrollment

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Study locations

1 of 1 sites recruiting
  • NanFang Hospital of Southern Medical University
    Guangzhou, Guangdong 510515, China
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07539727
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Apr 20, 2026
Start date
Jan 1, 2025
Primary completion
Dec 31, 2027 (estimated)
Completion
Jan 1, 2029 (estimated)
Last update
Apr 20, 2026
View the source record on ClinicalTrials.gov ↗

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