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The team decided to close this study since we are not recruiting and collecting any data.
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| Name | Class |
|---|---|
| The Alfred | OTHER |
| Melbourne Health | OTHER |
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The investigators hypothesize that a novel method for oligosaccharide supplementation, in the form of nutritional bars and/or muesli high in fructans and galacto-oligosaccharides (GOS), will be a safe and tolerable therapeutic intervention in patients with Crohn's disease (CD) in remission.
Subjects age >/= 19 years with the diagnosis of CD for >/= 6 months, currently in remission based on the Harvey-Bradshaw Index score (\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 1 placebo muesli bars and 1 serving placebo muesli per day (0.55 g total fructans/GOS) |
|
| Moderate Oligosaccharide Group | Experimental | 1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS) |
|
| High Oligosaccharide Group | Experimental | 1 intervention muesli bar and 1 serving intervention muesli per day (5.43 total fructans/GOS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 1 placebo muesli bar and 1 serving placebo muesli per day (0.55 g total fructans/GOS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in overall GI symptoms | The primary outcome will be the difference in overall gastrointestinal symptoms quantified by the VAS, at study completion compared to baseline, averaged over the 5-days in which the diet diaries are being completed among the 3 study groups. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability assessment including overall gastrointestinal symptoms and specific symptoms | Secondary outcomes concerning tolerability will include differences in the individual gastrointestinal symptoms (abdominal bloating, abdominal pain, gut rumbling, flatulence) quantified by the VAS at study completion compared to baseline, averaged over the 5-days in which the diet diaries are being completed among the 3 study groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Bressler, MD | Division of Gastroenterology, Department of Medicine St. Paul's Hospital, Vancouver, BC Cananda | Principal Investigator |
| Peter Gibson, MD | Department of Gastroenterology Alfred Hospital, Melbourne, Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology Alfred Hospital | Melbourne | Australia | ||||
| GI Clinic, St. Paul's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21472012 | Background | Talley NJ, Abreu MT, Achkar JP, Bernstein CN, Dubinsky MC, Hanauer SB, Kane SV, Sandborn WJ, Ullman TA, Moayyedi P; American College of Gastroenterology IBD Task Force. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011 Apr;106 Suppl 1:S2-25; quiz S26. doi: 10.1038/ajg.2011.58. No abstract available. | |
| 17904915 |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Moderate Oligosaccharide Group | Dietary Supplement | 1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS) |
|
| High Oligosaccharide Group | Dietary Supplement | 1 placebo muesli bar and 1 serving placebo muesli per day (5.43 g total fructans/GOS) |
|
| 4 weeks |
| Fatigue assessment | Secondary endpoints concerning differences in the scores of the overall FIS (fatigue impact scale) and sub-categories (physical, cognitive, psychosocial) at study completion compared to baseline in all 3 study groups | 4 weeks |
| Quality of Life Assessment | Secondary endpoints concerning differences in physical components summary (PCS) and the mental component summary (MSC) scores at study completion compared to baseline in all 3 study groups respectively | 4 weeks |
| Mood Assessment | Secondary endpoints concerning mood that will include differences in state anxiety, state curiosity, state anger, and state depression scores of the STPI at study completion compared to baseline in all 3 study groups respectively | 4 weeks |
| Disease Activity Asessment | The proportion of participants who relapse, as well as the time to relapse at study completion between groups. | 4 weeks |
| Adherence Assessment | Adherence will be estimated and compared between groups at study completion | 4 weeks |
| Vancouver |
| British Columbia |
| V6Z 1Y6 |
| Canada |
| Kappelman MD, Rifas-Shiman SL, Kleinman K, Ollendorf D, Bousvaros A, Grand RJ, Finkelstein JA. The prevalence and geographic distribution of Crohn's disease and ulcerative colitis in the United States. Clin Gastroenterol Hepatol. 2007 Dec;5(12):1424-9. doi: 10.1016/j.cgh.2007.07.012. Epub 2007 Sep 29. |
| 18796097 | Result | Herrinton LJ, Liu L, Lewis JD, Griffin PM, Allison J. Incidence and prevalence of inflammatory bowel disease in a Northern California managed care organization, 1996-2002. Am J Gastroenterol. 2008 Aug;103(8):1998-2006. doi: 10.1111/j.1572-0241.2008.01960.x. |
| 19174807 | Result | Lichtenstein GR, Hanauer SB, Sandborn WJ; Practice Parameters Committee of American College of Gastroenterology. Management of Crohn's disease in adults. Am J Gastroenterol. 2009 Feb;104(2):465-83; quiz 464, 484. doi: 10.1038/ajg.2008.168. Epub 2009 Jan 6. |
| 10659482 | Result | Pai CG, Khandige GK. Is Crohn's disease rare in India? Indian J Gastroenterol. 2000 Jan-Mar;19(1):17-20. |
| 15947013 | Result | El Mouzan MI, Abdullah AM, Al Habbal MT. Epidemiology of juvenile-onset inflammatory bowel disease in central Saudi Arabia. J Trop Pediatr. 2006 Feb;52(1):69-71. doi: 10.1093/tropej/fmi039. Epub 2005 Jun 9. |
| 15930979 | Result | Ouyang Q, Tandon R, Goh KL, Ooi CJ, Ogata H, Fiocchi C. The emergence of inflammatory bowel disease in the Asian Pacific region. Curr Opin Gastroenterol. 2005 Jul;21(4):408-13. |
| 16246187 | Result | Aghazadeh R, Zali MR, Bahari A, Amin K, Ghahghaie F, Firouzi F. Inflammatory bowel disease in Iran: a review of 457 cases. J Gastroenterol Hepatol. 2005 Nov;20(11):1691-5. doi: 10.1111/j.1440-1746.2005.03905.x. |
| 3726680 | Result | Wright JP, Froggatt J, O'Keefe EA, Ackerman S, Watermeyer S, Louw J, Adams G, Girdwood AH, Burns DG, Marks IN. The epidemiology of inflammatory bowel disease in Cape Town 1980-1984. S Afr Med J. 1986 Jul 5;70(1):10-5. |
| D007410 | Intestinal Diseases |