Safety and Feasibility of Oligofructose-Enriched Inulin in Pediatric Inflammatory Bowel Disease. Short title: The TII Trial: Treating IBD with Inulin (TII)
- To evaluate the effect of the prebiotic fiber inulin on the microbiome of children with IBD who have subclinical disease activity (patients with no symptoms but elevated fecal calprotectin)
- To evaluate the efficacy of the prebiotic fiber inulin in reducing gut inflammation (fecal calprotectin) in IBD
Severity: Clinical remission
The study may be an option for you if:
- You are between 8 and 21 years old
- You have been diagnosed with inflammatory bowel disease and have been on stable IBD therapy for at least 3 months
- Your disease is clinically inactive (no symptoms) but you have a mildly elevated stool calprotectin
- You have not used any systemic steroids or antibiotics within the past month
- You never have had a bowel resection
- The purpose of this clinical research study is to test whether taking a prebiotic fiber supplement, called inulin, can beneficially shift the microbiome, or the bacterial flora of the gut, in patients with IBD.
- This study will also evaluate if those shifts in the gut microbiome lead to a decrease in gut inflammation by measuring stool calprotectin before and after the intervention. Participants will be taking the fiber inulin (tasteless and odorless) or placebo (inactive treatment) everyday for 8 weeks.
- Samples to measure the gut microbiome and calprotectin will be collected at baseline, at week 4, at the end of the intervention (week 8) and 8 weeks after terminating the intervention (week 16).
Description of treatment or intervention (Mechanism of Action)
- Prebiotics are specialized plant fibers that act like "fertilizers" that stimulate the growth of healthy and protective bacteria in the gut.
- Inulin is a type of prebiotic fiber that is naturally found in many fruits and vegetables.
- Previous studies have demonstrated that digestion of the fiber inulin by bacteria in the large bowel (colon) leads to an increase in production of metabolites called short chain fatty acids (SCFAs).
- SCFAs have been shown to have an anti-inflammatory effect, and we know that patients with IBD have a decrease in those beneficial SCFAs.
- Therefore, we hypothesize that prebiotic inulin supplementation will benefit children with IBD by increasing the abundance of healthy SCFA-producing bacteria and their metabolites, resulting in a decrease in gut inflammation.
Patient Participation Requirements
- The entire study will take place remotely
- There are no in person visits required
- The length of the study is 16 weeks, and involves:
- an introductory visit over the phone
- collecting samples including stool
- rectal swabs and urine at 4 time points
- taking inulin or a placebo everyday for 8 weeks
- completing diet questionnaires at 2 time points during the study
Possible risks and side effects
- Increasing your daily intake of fiber by taking a supplement may possibly lead to some gastrointestinal side effects such as bloating, flatulence, diarrhea and abdominal pain.
- These effects are typically transient and disappear after a few days to a week.
Progress to date