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

Crohn's Disease Clinical Trial

Official title:

Assessing the Tolerability of Oligosaccharide Supplementation in Patients With Crohn's Disease: A Randomized, Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02193750
• Other study ID #: H14-01420
• Status: Terminated
• Phase: N/A
• Start date: August 2015
• Est. completion date: September 2020

Study information

• Verified date: April 2021
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Subjects age >/= 19 years with the diagnosis of CD for >/= 6 months, currently in remission based on the Harvey-Bradshaw Index score (

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Dietary Supplement:
• Placebo
1 placebo muesli bar and 1 serving placebo muesli per day (0.55 g total fructans/GOS)
• Moderate Oligosaccharide Group
1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)
• High Oligosaccharide Group
1 placebo muesli bar and 1 serving placebo muesli per day (5.43 g total fructans/GOS)

Locations

Country	Name	City	State
Australia	Department of Gastroenterology Alfred Hospital	Melbourne
Canada	GI Clinic, St. Paul's Hospital	Vancouver	British Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of British Columbia	Melbourne Health, The Alfred

Countries where clinical trial is conducted

Australia,  Canada, 

References & Publications (9)

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. — View Citation

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. Epub 2005 Jun 9. — View Citation

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. — View Citation

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. Ep — View Citation

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 — View Citation

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. Review. — View Citation

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

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Disease Activity Asessment	The proportion of participants who relapse, as well as the time to relapse at study completion between groups.	4 weeks
Secondary	Adherence Assessment	Adherence will be estimated and compared between groups at study completion	4 weeks