Human and Microbial Determinants of the Onset of IBD Flares | NCT06967311

Studies
Human and Microbial Determinants of the Onset of IBD Flares

NCT06967311

Sponsor

Viome

Status

Recruiting

Last Update Posted

Jun 15, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

IBD (Inflammatory Bowel Disease)

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2025Actual

Primary Completion Date

Feb 2030Estimated

Completion Date

Feb 2030Estimated

First Submitted Date

Mar 28, 2025

First Submission Date that Met QC Criteria

May 7, 2025

First Posted Date

May 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2025

Last Update Posted Date

Jun 15, 2025Actual

Name	Class
Universidade Federal de Santa Catarina	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will collect longitudinal biological samples and survey data to identify the triggers of IBD flares.

Detailed Description

This is a longitudinal observational study whose goals are to identify:

Microbial and human molecular triggers of IBD relapses, Microbial and human molecular pathways strongly associated with flares that could be targeted with nutrition with a therapeutic potential, Biomarkers of IBD for Dx purposes, Identify microbial functions associated with release of BH4.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Label	Type	Description	Intervention Names
Inflammatory Bowel Disease (IBD)		Individuals diagnosed with IBD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stool microbial KEGG orthologs (KOs) associated with IBD	Metatranscriptomic tests will be used to quantify microbial KOs in stool samples. At the end of the study, we will use machine learning to identify KOs whose expression is associated with IBD.	For 12 months from enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient at Universidade Federal de Santa Catarina (UFSC) Hospital, under care of Dr. Vivian Menegassi

Exclusion Criteria:

Cancer Diagnosis/Treatment
Under 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults diagnosed with Crohn's Disease or Ulcerative Colitis that are patients at Universidade Federal de Santa Catarina (UFSC) Hospital and under care of Dr. Vivian Menegassi

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Raquel Clinical Research Coordinator	Contact	425-368-5248		studies@viome.com
Momo Vuyisich Chief Science Officer, PhD	Contact			studies@viome.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
LABOX, Department of Biochemistry, Universidade Federal de Santa Catarina	Recruiting	Florianópolis	Santa Catarina	88037-100	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D015212	Inflammatory Bowel Diseases

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

Browse Leaves

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Browse Branches

Not provided