PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial

Crohn Disease Clinical Trial

— PROMOTE  

Official title:

PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06301477
• Other study ID #: 23/109X
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: March 1, 2027

Study information

• Verified date: March 2024
• Source: Children's Hospital of Eastern Ontario
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

Inclusion Criteria:

• Age between 8.0 to 16.9 years of age.
• Capable of giving informed consent, or if appropriate, have an acceptable representative capable of giving consent on the participant's behalf.
• Established Crohn's Disease (CD) diagnosis with the site of disease involving at least the terminal ileum or ascending colon.
• CD is in clinical remission or with mild stable disease activity (weighted Pediatric Crohn's Disease Activity Index of 0 to 39.5).
• Receiving infliximab or adalimumab anti-TNFa monoclonal antibody medication for treatment of CD.
• No changes in medical treatment for the previous month and without anticipated changes for the next month.
• Ability and willingness to comply with study procedures (e.g., stool collection) for the entire length of the study.

Exclusion Criteria:

• Allergy to RS or excipients.
• Co-existing diagnosis with diabetes mellitus type 1.
• Treatment with another investigational drug or intervention throughout the study.
• Current illicit drug or alcohol dependence.
• Inability or unwillingness of an individual or legal guardian to give written informed consent.
• Other conditions requiring immunomodulating or biological medications.
• Pregnancy.
• Participant's microbiota does not increase butyrate production utilizing any RS from the assembled panel as measured through the RapidAIM ex vivo assay.

Related Conditions & MeSH terms

• Crohn Disease
• Inflammatory Bowel Diseases

Intervention

Other:
• Resistant Starch
7.5g/m2 or 5.0g/m2 (body surface area) resistant starch oral consumption
• Placebo
Placebo oral consumption of food-grade cornstarch

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of butyrate production by assessing expression of enzymes using metaproteomic/transcriptomic analysis	Measures of restoration and sustainment of butyrate production by using metaproteomic/transcription to assess the expression of enzymes invovled in butyrate production	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Primary	Measure of butyrate production by assessing production of shorty-chain-fatty-acids including butyrates using metabolomics analysis	Measures of restoration and sustainment of butyrate production by using metabolomics analysis to assess production of short-chain-fatty acids including butyrate.	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Primary	Measure of butyrate production by assessing increases in butyrate producers using metagenomics/16S analysis	Measures of restoration and sustainment of butyrate production by metagenomics/16s analysis to assess increases in butyrate producers	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks.
Secondary	Change in intensification as measured by anti-TNFa dose escalation	To help contextualize the anti-TNFa dose escalation (if applicable), Infliximab or adalimumab information will be recorded at baseline, 12 weeks, 24 weeks, 36 weeks and 48 weeks after start of study product. Type of anti-TNFa drug prescribed, amount of anti-TNFa prescribed, dose changes in timing of administration, trough drug serum levels, weight changes and reason for dose changes will be recorded	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Secondary	Change in intensification as measured by anti-TNFa interval shortening	To help contextualize the anti-TNFa interval shortening (if applicable), Infliximab or adalimumab information will be recorded at baseline, 12 weeks, 24 weeks, 36 weeks and 48 weeks after start of study product. Type of anti-TNFa drug prescribed, amount of anti-TNFa prescribed, dose changes in timing of administration, trough drug serum levels, weight changes and reason for dose changes will be recorded	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Secondary	Change in disease activity	Weighted Pediatric Crohn's Disease Activity Index (wPCDAI) ranges from 0 to 125 points (<12.5 = remission, 12.5 to 40.0 = mild, >40.0 = moderate, >57.5 = severe).	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Secondary	Changes in intestinal mucosal inflammation by measuring fecal calprotectin through stool samples	Measure of fecal calprotectin	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Secondary	Changes in biomarkers of inflammation by measuring c-reactive protein through blood samples	Measure of c-reactive protein	Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Secondary	Changes in patient reported disability outcomes as measured by the IBD Disability Index Questionnaire	The IBD Disability Index consists of 28 questions and a higher overall score is indicative of greater disability.	Baseline, 24 weeks, 48 weeks
Secondary	Changes in patient reported quality of life outcomes as measured by the IMPACT III Questionnaire	The IMPACT III questionnaire ( a health related quality of life questionnaire) consists of 35 questions and ranges in score from 0 to 231. A higher score represents a higher quality of life.	Baseline, 24 weeks, 48 weeks
Secondary	Changes in parent/caregiver reported quality of life outcomes as measured by the IMPACT III-P	The IMPACT III-P questionnaire ( a health related quality of life questionnaire) consists of 35 questions and ranges in score from 0 to 231. A higher score represents a higher quality of life.	Baseline, 24 weeks, 48 weeks