Does the Microbiome in IBD Change Alongside Special Treatment Scenarios?

NCT02526251 | Completed DMC

• 1 other identifier: 49341
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this cohort study is to map, during one year in an e-health setting, patients having Inflammatory Bowel Disease (IBD) with mild to moderate activity in relation to dysbiosis (gut bacteria) and inflammation burden measured by disease activity questionnaires (HBI and SCCAI) and Fecal Calprotectin (FC) on any smart phone. And Secondarily how dysbiosis defined by a dysbiosis index (DI) ranging from 1-5 is related to changes in disease activity and FC under different treatments scenarios. Is a certain DI or specific bacteria probes related to increase or reduced relapse rate. Moreover change in above mentioned parameters/indices will also be correlated to QoL and a fatigue score.

Conditions

Inflammatory Bowel Disease

Keywords

IBD; Fecal calprotectin; Microbiome; Dysbiosis; Disease activity; telemedicine

Outcome Measures

Primary Outcomes (1)

• Microbiome

  Platform signal based on PCR technique of variable regions of 16S rRNA of 54 bacterial probes identifying specific gut bacteria on genus and species level. These platform signals goes through an algorithm to generate a Dysbiosis index (DI) ranging from 1-5. GA Analysis has developed this algorithm.

  one year

Secondary Outcomes (1)

• Total inflammation burden (TIBS)

  one year

Interventions

observational OTHER

No intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

IBD patients in remission or mild to moderate active

You may qualify if:

• IBD patients in remission, SCCAI ≤ 2 (Simple Clinical Colitis Activity Index )) or HBI \< 5 (Harvey \& Bradshaw Activity Index ) or in mild to moderate disease activity ( SCCAI 3-4, HBI \< 16)
• IBD patients who can read, speak and understand Danish
• IBD patients that can take advantage of the Internet and wireless network 18 years or older

You may not qualify if:

• IBD patients with severe disease activity ( HB \> 16 SCCAI ≥ 5 )
• IBD patients with social, medical or psychological issues of a more complex character
• IBD patients with complex issues such as drug and alcohol problems, severe mental / psychiatric disorders and / or serious social impact.
• IBD patients who cannot attend due to language barrier or cognitive disorder.
• Age less than 18 years.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead

Study Sites (1)

North Zealand university hospital, Gastro unit

Frederikssund, Capital Region, 3600, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Dysbiosis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Pia Munkholm, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 18, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 28, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)