Treating IBD With Inulin
מילות מפתח
תַקצִיר
תיאור
The pathogenesis of inflammatory bowel disease (IBD) is thought to be due to a combination of genetic, environmental and immunological factors. From a clinical stand point, there is great interest in determining if manipulation of the gut microbiota may be a viable therapeutic strategy in IBD patients. One such strategy involves the use of prebiotic. Prebiotics are oligosaccharides that cannot be enzymatically hydrolyzed in the small intestine, however serve as substrates for fermentation by commensal bacteria in the colon.
Investigators propose to evaluate the modulatory effects of the prebiotic inulin on the composition and function of the microbiota of children with IBD and determine the efficacy of this dietary intervention in reducing disease activity.
תאריכים
| אומת לאחרונה: | 03/31/2020 |
| הוגש לראשונה: | 08/27/2018 |
| ההרשמה המשוערת הוגשה: | 08/27/2018 |
| פורסם לראשונה: | 08/30/2018 |
| העדכון האחרון הוגש: | 04/07/2020 |
| עדכון אחרון פורסם: | 04/09/2020 |
| תאריך תחילת לימוד בפועל: | 10/28/2018 |
| תאריך סיום משוער משוער: | 09/30/2021 |
| תאריך סיום משוער ללימודים: | 09/30/2022 |
מצב או מחלה
התערבות / טיפול
Dietary Supplement: Inulin
Dietary Supplement: Placebo
שלב
קבוצות זרועות
| זְרוֹעַ | התערבות / טיפול |
|---|---|
| Experimental: Inulin Oligofructose-enriched Inulin (OI) administered for 8 weeks | Dietary Supplement: Inulin Consumed as a powder, 8g/d for children <50kg and 16g/d for children ≥50kg, divided in 2 daily doses. |
| Placebo Comparator: Placebo Maltodextrin placebo administered for 8 weeks | Dietary Supplement: Placebo Consumed as a powder, 8g/d for children <50kg and 16g/d for children ≥50kg, divided in 2 daily doses. |
קריטריונים לזכאות
| גילאים הזכאים ללימודים | 8 Years ל 8 Years |
| מינים הזכאים ללימודים | All |
| מקבל מתנדבים בריאים | כן |
| קריטריונים | Inclusion Criteria - Males or females age 8-21 years. - Parental/guardian permission (informed consent) and child assent. - Pediatric diagnosis of inflammatory colonic or ileocolonic Crohn's disease (CD), ulcerative colitis (UC) or inflammatory bowel disease-unclassified (IBDU), as defined by endoscopy, radiology, and clinical findings. - Clinical disease activity index compatible with: - For patients with CD: - Pediatric Crohn's Disease Activity Index (PCDAI) ≤15 or short PCDAI (sPCDAI) ≤17.5 (if unable to complete full PCDAI) or physician global assessment (PGA) compatible with quiescent disease at time of enrollment - No visible blood in bowel movements in the 7 days prior to enrollment - Normal inflammatory laboratory markers (CRP, ESR, Albumin in the case of PCDAI) - For patients with UC/IBDU: - Pediatric Ulcerative Colitis Activity Index (PUCAI) ≤ 20 or PGA compatible with quiescent disease - No visible blood in bowel movements in the 7 days prior to enrollment - Fecal calprotectin (FC) ≥ 50 ≤ 500mcg/g or FC outside of this range but within the 20% margin of error of 500 mcg/g Exclusion Criteria - Positive culture for an enteropathogen up to a month prior to enrollment or during the study period. - PCDAI >15 or sPCDAI >17.5 for patients with CD or PUCAI >20 for patients with UC or IBDU - Presence of an ostomy or prior colonic resection - Short bowel syndrome - Isolated perianal disease. - Patients requiring escalation of treatment during the intervention or preceding enrollment, defined by the following: change in dose of azathioprine/methotrexate during the preceding 12 weeks or 5-amino salicylic acid during the preceding 2 weeks, change in dosing or interval of anti-TNF therapy, or any other biologic therapy (ustekinumab, vedolizumab) for the preceding infusion or injection. De-escalation of therapy (i.e stopping a medication, or spacing the interval of medication or decreasing the dose of a medication) is acceptable. - Use of oral steroids (with the exception of budesonide) within the last 4 weeks of the screening visit or during the study period. - Use of any antibiotics during the preceding 4 weeks or during the study period. - Use of commercially available prebiotic preparations during the preceding 3 weeks prior to starting the study drug or during the study period. - Non-inflammatory Crohn's disease (stricturing and/or penetrating disease behavior) - Isolated small bowel Crohn's disease - Previous ileocecal resection |
תוֹצָאָה
מדדי תוצאות ראשוניים
1. Alteration of gut microbiota and metabolome [8 weeks]
אמצעי תוצאה משניים
1. Change in fecal calprotectin level [8 weeks]
