Decentralized Dietary UC Pilot Trial

Colitis, Ulcerative Clinical Trial

Official title:

A Pilot Study Investigating a Decentralized Approach to Studying Dietary Intervention in Patients With Ulcerative Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02357537
• Other study ID #: TLS-UC-003
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2015
• Last updated: November 5, 2015
• Start date: January 2015

Study information

• Verified date: November 2015
• Source: Transparency Life Sciences
• Contact: Justine States
• Phone: (617) 732-9110
• Email: dietaryUCTrial[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to assess differences in remote and on-site patient study participation in the State of Massachusetts, as well as the significance of dietary interventions and their impact on UC. The study will activate one site with a Principal Investigator who will utilize each subject's local care system (local Gastroenterologist) to collect study data, along with telemonitoring and video visits, to make key study assessments and decisions regarding subjects' progression in the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Males and females between the ages of 18 and 80, inclusive, who reside in the state of Massachusetts.

2. Ability and willingness to provide documented informed consent and to comply with the study procedures, including in-person visits for Arm 1 and video visits for Arm 2.

3. Documented history of moderate to severe active UC

4. Disease duration of =12 weeks at the time of screening (diagnosed according to American College of Gastroenterology practice guidelines)

5. Screening fecal calprotectin>350 mg/g

6. Diagnosis of moderately to severely active UC, including historical endoscopy sub score =2; a rectal bleeding sub score =1 and disease activity a minimum of 25 cm from the anal verge.

7. Documented (via video or report) endoscopy performed within 2 years prior to randomization.

8. Access to a computer or mobile device with internet connection and an active email address.

Exclusion Criteria:

1. Prior extensive colonic resection, subtotal or total colectomy or planned surgery for UC

2. Past or present ileostomy or colostomy

3. Short bowel syndrome

4. Diagnosis of indeterminate colitis, fulminant colitis, toxic megacolon

5. Past or present fistula or abdominal abscess

6. History or current evidence of colonic mucosal dysplasia

7. Use of tube feeding, defined formula diets or parenteral alimentation/nutrition which has not been discontinued =3 weeks prior to study enrollment

8. Use of anticoagulants, herbal supplements and omega-3/fish oil supplements during the study

9. Crohn's Disease

10. Significant uncontrolled co-morbidity, such as neurological, cardiac (e.g., moderate to severe heart failure NYHA class III/IV), pulmonary, renal, hepatic, endocrine or gastrointestinal disorders

11. History of alcohol, drug or chemical abuse within 6 months prior to screening

12. Pregnant females, those intending to become pregnant, and those who are lactating

13. Current participation in any other clinical trial

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Behavioral:
• Combined Anti-inflammatory Diet (CAID)
The CAID requires participants to modify their diet to include certain types of foods that may have anti-inflammatory properties. Participants on the CAID will be required to abstain from red meat and alcoholic beverages.

Locations

Country	Name	City	State
United States	Crohn's and Colitis Center at Brigham and Women's Hospital	Brookline	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Transparency Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score)	Comparison of the proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score between Study Arms 1 and 2.	Week 1
Primary	Compliance (proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study)	Comparison of the proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study between Study Arms 1 and 2.	Week 7
Primary	Combined Anti-inflammatory Diet (Change from baseline in fecal calprotectin/microbiome levels)	Change from baseline in fecal calprotectin/microbiome levels between Control (standard nutritional advice) and CAID (dietary intervention) arms.	Weeks 0, 5 and 7
Secondary	Mayo Score and Patient Simple Clinical Colitis Activity Index Difference (Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index)	Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index between Control and CAID (dietary intervention).	Weeks 1 and 7
Secondary	Adverse Events	Difference in incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) between Study Arms 1 and 2 and between Control and CAID (dietary intervention) arms.	Weekly through week 11
Secondary	Dietary Compliance Comparison	Comparison of patient non-compliance events with dietary regimen between arms 1 and 2.	Week 7
Secondary	Participant Satisfaction Survey	Difference in reported patient satisfaction with trial participation between arms 1 and 2.	Week 7
Secondary	Mayo Score Discrepancy Frequency	Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Endoscopy Sub-Scores for Arm 2 patients at baseline.	Week 7
Secondary	Physician's Global Assessment Discrepancy Frequency	Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Physician's Global Assessment Sub-Score for Arm 2 patients at baseline.	Week 7