Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease

NCT02193750 | Terminated

• 1 other identifier: H14-01420
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Crohn's Disease

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Tolerability assessment including overall gastrointestinal symptoms and specific symptoms

  4 weeks

• Fatigue assessment

  4 weeks

• Quality of Life Assessment

  4 weeks

• Mood Assessment

  4 weeks

• Disease Activity Asessment

  4 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

1 placebo muesli bars and 1 serving placebo muesli per day (0.55 g total fructans/GOS)

Dietary Supplement: Placebo

Moderate Oligosaccharide Group

EXPERIMENTAL

1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)

Dietary Supplement: Moderate Oligosaccharide Group

High Oligosaccharide Group

EXPERIMENTAL

1 intervention muesli bar and 1 serving intervention muesli per day (5.43 total fructans/GOS)

Dietary Supplement: High Oligosaccharide Group

Interventions

Placebo DIETARY_SUPPLEMENT

1 placebo muesli bar and 1 serving placebo muesli per day (0.55 g total fructans/GOS)

Placebo

Moderate Oligosaccharide Group DIETARY_SUPPLEMENT

1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)

Moderate Oligosaccharide Group

High Oligosaccharide Group DIETARY_SUPPLEMENT

1 placebo muesli bar and 1 serving placebo muesli per day (5.43 g total fructans/GOS)

High Oligosaccharide Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>/= 19 years
• diagnosed with CD for \>/= 6 months, currently in remission based on the Harvey-Bradshaw Index score (\</= 4 points) and C-reactive protein (\<5mg/L)

You may not qualify if:

• unable to provide informed consent;
• have significant hepatic, renal, endocrine, respiratory, neurological, or cardiovascular disease;
• confirmed diagnosis of celiac disease, or have suspected celiac disease and are following a gluten-free diet to manage symptoms with an elevated screening anti-tissue transglutaminase antibody test;
• significant complications of CD which includes a history of extensive colonic resection, including subtotal or total colectomy, history of \>/= 3 small bowel resections or received a diagnosis of short bowel syndrome, current ileostomy, colostomy or ileal-anal pouch, or a fixed symptomatic intestinal stenosis;
• antibiotic use in the 4 weeks prior to study start;
• use of any rectal preparations in the 2 weeks prior to study start;
• use of any non-steroidal anti-inflammatory drugs in the 2 weeks prior to study start;
• use of commercial probiotic supplements in the 4 weeks prior to study start
• change in CD therapy in the 4 weeks prior to study start (excluding steroid taper, however steroid dosing must be stable for 2 weeks prior to study start);
• recently been adhering to a novel dietary intervention for alternative health issues within the last 4 weeks prior to study start.

Sponsors & Collaborators

• University of British Columbia: lead
• The Alfred: collaborator
• Melbourne Health: collaborator

Study Sites (2)

Department of Gastroenterology Alfred Hospital

Melbourne, Australia

Location

GI Clinic, St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (9)

• 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.

  PMID: 21472012 BACKGROUND

• 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.

  PMID: 17904915 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.

  PMID: 18796097 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.

  PMID: 19174807 RESULT

• Pai CG, Khandige GK. Is Crohn's disease rare in India? Indian J Gastroenterol. 2000 Jan-Mar;19(1):17-20.

  PMID: 10659482 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.

  PMID: 15947013 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.

  PMID: 15930979 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.

  PMID: 16246187 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.

  PMID: 3726680 RESULT

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 18, 2014
• Study Start: August 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

CA (1); AU (1)