CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 73 enrolled
Drug / intervention
Active fructo-oligosaccharide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00343642
NCT00343642Phase 2Completed
CompareCT.gov

Dietary Treatment of Crohn's Disease

Rush University Medical Center·interventional·Posted Jun 23, 2006·Updated Jun 9, 2021

In Brief

A Phase 2 clinical trial evaluating Active fructo-oligosaccharide, Placebo fructo-oligosaccharide, and 1 other intervention for Crohn's Disease and Inflammatory Bowel Disease. Completed, enrolled 73 participants across 2 sites.

Detailed Summary

Our objective is to determine whether a specific dietary intervention or a fructooligosaccharide (FOS) supplement has anti-oxidant or prebiotic effects and whether it is beneficial in the treatment of Crohn's Disease (CD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease, Inflammatory Bowel Disease
CountriesUnited States
CollaboratorsNational Center for Complementary and Integrative Health (NCCIH)

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 23, 2006
Enrollment StartSep 1, 2006
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 20.0 years ago

Interventions

Active fructo-oligosaccharidedrug

2 teaspoons of active fructo-oligosaccharides daily and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans

Placebo fructo-oligosaccharidedrug

2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily) and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans

Dietdietary

A restrictive anti-inflammatory diet developed by the research team and 2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily)