Diet Study on Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

Dietary Control of Fat to Modify Colonic Inflammation in Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147598
• Other study ID #: 20130716
• Status: Completed
• Phase: N/A
• Start date: February 25, 2015
• Est. completion date: September 11, 2018

Study information

• Verified date: October 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to determine the effectiveness of a low-fat or standard American diet (high in fat) in helping people with ulcerative colitis improve their symptoms and the signs of inflammation in blood tests and in bowel biopsies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 11, 2018
• Est. primary completion date: September 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male or Female =18 and =70 years old

2. History of UC of at least 3 months duration

3. UC should be confirmed by colonoscopy within two years of entry into the study

4. Patients with mild to moderate UC, or patients in remission that have had active disease within the past 18 months, regardless of treatment with mesalamines, immunosuppressants, anti-TNFs and/or vedolizumab

• Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for =2 weeks prior to screening

• Patients treated with anti-TNFs or immunosuppressants (AZA, 6-MP, or methotrexate) at screening must have been on a stable dose for =8 weeks and remain on the same dose during the treatment period

• Patients on steroids can be on no more than prednisone 20mg daily or budesonide 9mg daily at screening. If clinically indicated, tapering of steroids after 4 weeks of intervention may occur. Prednisone may be tapered by no more than 2.5mg/week and budesonide by no more than 3mg/week.

• Patients on infliximab, premedication may include intravenous corticosteroid

5. No antibiotic use or probiotic use within 4 weeks prior to screening

6. Signed written informed consent for enrollment into the study

Exclusion Criteria:

1. Patients with Crohn's Disease and Celiac Disease

2. History of colonic dysplasia except for adenoma on prior surveillance colonoscopy

3. Patients with altered anatomy: prior colectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy

4. Clinical manifestations concerning for fulminant disease or toxic megacolon

5. Patients with stool sample positive at during screening period or at least <12 weeks for ova, parasites, or culture for aerobic pathogens including: Aeromonas, Plesiomonas, Shigella, Yersinia, Campylobacter and E.coli spp. or positive for Clostridium difficile B toxin in stools

6. Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening

7. Need for prednisone >20mg daily or budesonide >9mg daily at the time of screening

8. Received intravenous corticosteroids within 2 weeks prior to screening, during screening, or during the study period, except as premedication for anti-TNFs

9. Use of Total Parenteral Nutrition at the time of screening and during the study period

10. Anti-diarrheal use within 2 weeks prior to screening

11. Presence of any of the following laboratory abnormalities during screening period or at least <12 weeks

• Hemoglobin <8.0g/dl

• Albumin <2.8g/dl

12. Conditions/situations such as:

• Patients with short life expectancy

• Uncooperative behavior or any condition that could make the patient potentially non-compliant to the study procedures

• Patients with pacemaker

• Other significant or life-threatening co-morbidities in which diet intervention could negatively affect

13. Failure to meet any of the inclusion criteria

14. Poor compliance with diet during the study period

15. Failure to submit stool samples as indicated at each phase of the study

16. The need for antibiotic use during the study period

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• LFD
Participants will receive daily prepared food trays to achieve a diet with approximately 10% of total fat, 1-5% of calories from saturated fat, and 5-9% of MUFA and PUFA. This diet will contain an approximate ratio of 1:1 of omega-6/omega-3 fatty acids.
• SAD
Participants will receive daily prepared food trays to achieve a diet with approximately 35-40% of calories from fat, 10-11% of saturated fats, and 25-29% would be mono-unsaturated (MUFA) and PUFA. This diet will contain a 20-30:1 ratio of omega-6/omega-3 fatty acids, representing the current SAD.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Broad Medical Research Program Crohn's and Colitis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ).	sIBDQ is a 10-item shortened version of the original IBDQ assessing quality of life (QOL) with total scores ranging from 1 to 7 with a higher score indicating a better QOL.	Baseline, 4 weeks
Primary	Change in quality of life as measured by the Food-Related Quality of Life (FR-QoL-29) Questionnaire.	FR-QoL-29 is a 29-item questionnaire assessing quality of life (QOL) with total scores ranging from 29 to 145 with a score less than 90 suggesting poor food related QoL.	Baseline, 4 weeks
Primary	Change in quality of life as measured by the Medical Outcomes Short Form-36 (SF-36) Questionnaire.	SF-36 is a 36-item questionnaire assessing quality of life (QOL) with total scores ranging from 0 to 100 with a higher score indicating a better QOL.	Baseline, 4 weeks
Primary	Change in the expression of inflammatory markers in the colon.	Change in the expression of interleukin (IL)-1ß, IL-6 and Tumor Necrosis Factor alpha (TNFa) evaluated in pg/mL.	Baseline, 4 weeks
Primary	Change in the expression of cytokine in the colon.	Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluted in mg/L.	Baseline, 4 weeks
Primary	Change in intestinal microbiota	Change in relative abundance of the microbial communities evaluated as a percentage.	Baseline, 4 weeks
Secondary	Change in Ulcerative Colitis (UC) symptoms as measured by the partial Mayo score	The partial Mayo score ranges from 0 to 9 with a higher score indicating worsening UC symptoms.	Baseline, 4 weeks
Secondary	Change in UC symptoms as measured by the Simple Clinical Colitis Activity Index (SCCAI)	SCCAI score ranges from 0 to 19 with a higher score indicating worsening UC symptoms.	Baseline, 4 weeks
Secondary	Rate of adherence to fat intake	Adherence to fat intake is measured by the web-based daily food diary software Nutrihand.	Baseline, 4 weeks
Secondary	Rate of adherence to diet items	Adherence to diet items is measured by the web-based daily food diary software Nutrihand.	Baseline, 4 weeks