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Prebiotic
Oligofructose-enriched Inulin OI for Inflammatory Bowel Disease (TII Trial)
N/A
Waitlist Available
Led By Jessica Breton, MD
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
TII Trial Summary
This study is evaluating whether a prebiotic may help reduce disease activity in individuals with inflammatory bowel disease.
Eligible Conditions
- Inflammatory Bowel Disease
TII Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Alteration of gut microbiota and metabolome
Secondary outcome measures
Change in fecal calprotectin level
TII Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InulinExperimental Treatment1 Intervention
Oligofructose-enriched Inulin (OI) administered for 8 weeks
Group II: PlaceboPlacebo Group1 Intervention
Maltodextrin placebo administered for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oligofructose-enriched Inulin OI
2018
N/A
~60
Find a Location
Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
708 Previous Clinical Trials
8,580,956 Total Patients Enrolled
Beneo GmbHIndustry Sponsor
8 Previous Clinical Trials
350 Total Patients Enrolled
Jessica Breton, MDPrincipal InvestigatorChildren's Hospital of Philadelphia
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