search
Back to results

SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Specific Carbohydrate Diet
Mediterranean Diet
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Diet

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • History of active ulcerative colitis for at least 3 months before screening
  • Ulcerative colitis confirmed by colonoscopy or flexible sigmoidoscopy within 2 years of screening
  • Mild to moderate ulcerative colitis at the time of screening (2 < Mayo score < 12)
  • 1 ≤ Endoscopy subscore ≤ 2, or fecal calprotectin > 150 mcg/g within 2 weeks of screening
  • Patients on 5-aminosalicylates (e.g. mesalamine, etc.) must be on a stable dose for ≥ 4 weeks prior to screening
  • Patients on treatment with immunosuppressive (azathioprine/6-mercaptopurine and methotrexate) or biologic medications (infliximab, adalimumab, and golimumab) must be on stable dose for 8 weeks prior to baseline
  • At the time of baseline, patients may be on no more than 20 mg of prednisone and 9 mg of budesonide MMX

Exclusion Criteria:

  • Patients with Crohn's disease or indeterminate colitis
  • History of colectomy
  • Presence of ileal pouch or ostomy
  • History of colonic dysplasia
  • Evidence of active bacterial or viral gastroenteritis as indicated by positive stool studies for ova & parasites, clostridium difficile, and stool culture
  • Severe to fulminant colitis
  • Recent hospitalizations (within 2 weeks of screening) for ulcerative colitis requiring IV steroids
  • Recent systemic antibiotics use (within 2 weeks of screening)
  • Presence of the following labs indicative of severe colitis: a. Hemoglobin < 8.0 g/dl b. Albumin < 3.0 g/dl
  • Use of Total Parenteral Nutrition (TPN)
  • Active use of anti-diarrheal medications
  • Use of cyclosporine, tacrolimus, or thalidomide within 2 months prior to screening

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Specific Carbohydrate Diet

Mediterranean Diet

Arm Description

Exclusive consumption of the specific carbohydrate diet for 6 weeks

Exclusive consumption of the Mediterranean diet for 6 weeks

Outcomes

Primary Outcome Measures

Partial Mayo Clinic Score
The partial Mayo clinic score measures disease activity, on a scale of 0 to 9. The higher scores indicate more severe disease activity (the worse outcome).

Secondary Outcome Measures

Partial Mayo Clinic Score
The partial Mayo clinic score measures disease activity, on a scale of 0 to 9. The higher scores indicate more severe disease activity (the worse outcome).
Inflammatory Bowel Disease Questionnaire (IBDQ10)
The IBDQ10 measures quality of life, on a scale of 10 to 70. The higher scores indicate a better outcome (better quality of life).
Short Form (12) Health Survey (SF-12)
The SF-12 measures health-related quality of life, split into physical and mental health scores on a scale of 0 to 100. The higher scores indicate a better outcome.
Simple Clinical Colitis Activity Index (SCCAI)
The SCCAI measures disease activity, on a scale of 0 to 21. The higher scores indicate a worse outcome (more severe disease activity).
stool microbiome
Stool samples will be taken at screening/baseline and week 6 and 10 to assess change in fecal microbiome pattern, measured using R2Aspread plating, QiagenAllPrep RNA/DNA Mini kit, and whole genome shotgun sequencing.
fecal calprotectin
Stool samples will be taken at screening/baseline and week 6 and 10 to assess change in fecal calprotectin levels.
C-reactive protein
Blood will be drawn at baseline and week 6 to assess change in C-reactive protein levels.

Full Information

First Posted
February 24, 2020
Last Updated
May 27, 2022
Sponsor
Massachusetts General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04398550
Brief Title
SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
Official Title
Specific Carbohydrate Diet vs. Mediterranean Diet Therapy in Ulcerative Colitis - A Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 3, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Although patients and physicians have shown tremendous interest in the effect of diet on ulcerative colitis, there is a lack of significant evidence for providers to make practical recommendations with. In this study, the investigators hope to find out if dietary therapy by either the Specific Carbohydrate Diet (SCD) or the Mediterranean diet will help improve ulcerative colitis symptoms for patients with mild to moderately active disease. In addition, the investigators will compare disease activity and changes in the intestinal bacterial composition in the colon that occur with the Mediterranean or the SCD diet in active ulcerative colitis. This study is proposed as a single-site randomized trial consisting of 10 study visits to Massachusetts General Hospital (MGH) over 12 weeks. Participants in this study will be randomly assigned to the SCD or Mediterranean diet. The investigators ask that participants exclusively consume their assigned diet for 6 weeks, with all meals and snacks prepared by the metabolic kitchen within MGH. Participants will need to pick up food from MGH every 5-7 days, and will meet with a study dietitian before they begin and weekly during the diet therapy. There will be a screening visit to determine eligibility for the study, as well as study visits at weeks 0, 1, 2, 4, 6, and a 10 week follow-up at MGH, in which participants will fill out questionnaires. Participants will need to provide stool samples at screening, week 6, and week 10. In addition, blood will be drawn at week 0 and week 6, and if participants are getting a clinically-indicated colonoscopy at the time of screening, up to eight research biopsies may be collected during the procedure.
Detailed Description
This randomized, parallel-group feeding study will examine the influence of Mediterranean and SCD diets on gut microbiota, luminal inflammation, and disease-specific clinical indices in patients with mild to moderate ulcerative colitis (UC). 50 patients will be randomized to follow either the SCD or Mediterranean diet in a 1:1 ratio. Once informed consent is obtained, subjects will enter a 2-week screening period. Eligible subjects will be enrolled in the feeding treatment for 6 weeks followed by an additional follow-up visit at 10 weeks (4 weeks after feeding treatment completion). The total time to complete the study is 12 weeks. The metabolic kitchen within the Metabolism and Nutrition Research Center at MGH Translational and Clinical Research (TCRC) Unit will be responsible for preparing and packaging food for participants to pick up, as well as performing all necessary nutritional assessments. Participants will be provided with 3 meals and 2 snacks a day during the 6-week dietary intervention. Patient menus will be identical in each diet and will rotate on a 3-day basis. Total calories for each diet will be tailored according to each participant's body composition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The investigators, subjects, and remaining study staff will not be intentionally unblinded. Due to the nature of the study, subjects, study staff, and investigators interacting with the subjects will likely be able to figure out what diet the subject is assigned to, however, the exact diet will not be explicitly revealed to them.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Specific Carbohydrate Diet
Arm Type
Experimental
Arm Description
Exclusive consumption of the specific carbohydrate diet for 6 weeks
Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
Exclusive consumption of the Mediterranean diet for 6 weeks
Intervention Type
Other
Intervention Name(s)
Specific Carbohydrate Diet
Intervention Description
Diet restricts all but simple carbohydrates and allows for inclusion of fresh fruits, vegetables, unprocessed meats, and homemade lactose-free cheese and yogurt.
Intervention Type
Other
Intervention Name(s)
Mediterranean Diet
Intervention Description
Diet rich in whole vegetables, fruit, plant-based protein, and olive oil, with moderate amounts of seafood and dairy, and limited in sugar-sweetened goods, red meat, and nutrients like heme and sodium.
Primary Outcome Measure Information:
Title
Partial Mayo Clinic Score
Description
The partial Mayo clinic score measures disease activity, on a scale of 0 to 9. The higher scores indicate more severe disease activity (the worse outcome).
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Partial Mayo Clinic Score
Description
The partial Mayo clinic score measures disease activity, on a scale of 0 to 9. The higher scores indicate more severe disease activity (the worse outcome).
Time Frame
Week 1, Week 2, Week 4, Week 10 follow-up
Title
Inflammatory Bowel Disease Questionnaire (IBDQ10)
Description
The IBDQ10 measures quality of life, on a scale of 10 to 70. The higher scores indicate a better outcome (better quality of life).
Time Frame
Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
Title
Short Form (12) Health Survey (SF-12)
Description
The SF-12 measures health-related quality of life, split into physical and mental health scores on a scale of 0 to 100. The higher scores indicate a better outcome.
Time Frame
Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
Title
Simple Clinical Colitis Activity Index (SCCAI)
Description
The SCCAI measures disease activity, on a scale of 0 to 21. The higher scores indicate a worse outcome (more severe disease activity).
Time Frame
Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
Title
stool microbiome
Description
Stool samples will be taken at screening/baseline and week 6 and 10 to assess change in fecal microbiome pattern, measured using R2Aspread plating, QiagenAllPrep RNA/DNA Mini kit, and whole genome shotgun sequencing.
Time Frame
Week 6 and Week 10 follow-up
Title
fecal calprotectin
Description
Stool samples will be taken at screening/baseline and week 6 and 10 to assess change in fecal calprotectin levels.
Time Frame
Week 6 and Week 10 follow-up
Title
C-reactive protein
Description
Blood will be drawn at baseline and week 6 to assess change in C-reactive protein levels.
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of active ulcerative colitis for at least 3 months before screening Ulcerative colitis confirmed by colonoscopy or flexible sigmoidoscopy within 2 years of screening Mild to moderate ulcerative colitis at the time of screening (2 < Mayo score < 12) 1 ≤ Endoscopy subscore ≤ 2, or fecal calprotectin > 150 mcg/g within 2 weeks of screening Patients on 5-aminosalicylates (e.g. mesalamine, etc.) must be on a stable dose for ≥ 4 weeks prior to screening Patients on treatment with immunosuppressive (azathioprine/6-mercaptopurine and methotrexate) or biologic medications (infliximab, adalimumab, and golimumab) must be on stable dose for 8 weeks prior to baseline At the time of baseline, patients may be on no more than 20 mg of prednisone and 9 mg of budesonide MMX Exclusion Criteria: Patients with Crohn's disease or indeterminate colitis History of colectomy Presence of ileal pouch or ostomy History of colonic dysplasia Evidence of active bacterial or viral gastroenteritis as indicated by positive stool studies for ova & parasites, clostridium difficile, and stool culture Severe to fulminant colitis Recent hospitalizations (within 2 weeks of screening) for ulcerative colitis requiring IV steroids Recent systemic antibiotics use (within 2 weeks of screening) Presence of the following labs indicative of severe colitis: a. Hemoglobin < 8.0 g/dl b. Albumin < 3.0 g/dl Use of Total Parenteral Nutrition (TPN) Active use of anti-diarrheal medications Use of cyclosporine, tacrolimus, or thalidomide within 2 months prior to screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamed Khalili, MD, MPH
Phone
978-882-6709
Email
hkhalili@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Williams
Phone
617-643-9374
Email
kwilliams81@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamed Khalili, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Williams
Phone
617-643-9374
Email
kwilliams81@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Jessica McGoldrick
Email
jmcgoldrick2@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Hamed Khalili, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only de-identified information may be shared with other collaborators and entities involved in generating data.
Citations:
PubMed Identifier
24503132
Citation
Albenberg LG, Wu GD. Diet and the intestinal microbiome: associations, functions, and implications for health and disease. Gastroenterology. 2014 May;146(6):1564-72. doi: 10.1053/j.gastro.2014.01.058. Epub 2014 Feb 4.
Results Reference
background
PubMed Identifier
8200562
Citation
Ferguson A, Sedgwick DM, Drummond J. Morbidity of juvenile onset inflammatory bowel disease: effects on education and employment in early adult life. Gut. 1994 May;35(5):665-8. doi: 10.1136/gut.35.5.665.
Results Reference
background
PubMed Identifier
14973103
Citation
Poullis A, Foster R, Shetty A, Fagerhol MK, Mendall MA. Bowel inflammation as measured by fecal calprotectin: a link between lifestyle factors and colorectal cancer risk. Cancer Epidemiol Biomarkers Prev. 2004 Feb;13(2):279-84. doi: 10.1158/1055-9965.epi-03-0160.
Results Reference
background
PubMed Identifier
23598352
Citation
Martinez-Medina M, Denizot J, Dreux N, Robin F, Billard E, Bonnet R, Darfeuille-Michaud A, Barnich N. Western diet induces dysbiosis with increased E coli in CEABAC10 mice, alters host barrier function favouring AIEC colonisation. Gut. 2014 Jan;63(1):116-24. doi: 10.1136/gutjnl-2012-304119. Epub 2013 Apr 18.
Results Reference
background
PubMed Identifier
23203158
Citation
Stenman LK, Holma R, Eggert A, Korpela R. A novel mechanism for gut barrier dysfunction by dietary fat: epithelial disruption by hydrophobic bile acids. Am J Physiol Gastrointest Liver Physiol. 2013 Feb 1;304(3):G227-34. doi: 10.1152/ajpgi.00267.2012. Epub 2012 Nov 29.
Results Reference
background
PubMed Identifier
25597840
Citation
Lee D, Albenberg L, Compher C, Baldassano R, Piccoli D, Lewis JD, Wu GD. Diet in the pathogenesis and treatment of inflammatory bowel diseases. Gastroenterology. 2015 May;148(6):1087-106. doi: 10.1053/j.gastro.2015.01.007. Epub 2015 Jan 15.
Results Reference
background
PubMed Identifier
15361498
Citation
Jowett SL, Seal CJ, Pearce MS, Phillips E, Gregory W, Barton JR, Welfare MR. Influence of dietary factors on the clinical course of ulcerative colitis: a prospective cohort study. Gut. 2004 Oct;53(10):1479-84. doi: 10.1136/gut.2003.024828.
Results Reference
background
PubMed Identifier
15705205
Citation
Magee EA, Edmond LM, Tasker SM, Kong SC, Curno R, Cummings JH. Associations between diet and disease activity in ulcerative colitis patients using a novel method of data analysis. Nutr J. 2005 Feb 10;4:7. doi: 10.1186/1475-2891-4-7.
Results Reference
background
PubMed Identifier
25347472
Citation
Degagne E, Pandurangan A, Bandhuvula P, Kumar A, Eltanawy A, Zhang M, Yoshinaga Y, Nefedov M, de Jong PJ, Fong LG, Young SG, Bittman R, Ahmedi Y, Saba JD. Sphingosine-1-phosphate lyase downregulation promotes colon carcinogenesis through STAT3-activated microRNAs. J Clin Invest. 2014 Dec;124(12):5368-84. doi: 10.1172/JCI74188. Epub 2014 Oct 27.
Results Reference
background
PubMed Identifier
20461067
Citation
Jantchou P, Morois S, Clavel-Chapelon F, Boutron-Ruault MC, Carbonnel F. Animal protein intake and risk of inflammatory bowel disease: The E3N prospective study. Am J Gastroenterol. 2010 Oct;105(10):2195-201. doi: 10.1038/ajg.2010.192. Epub 2010 May 11.
Results Reference
background
PubMed Identifier
23273921
Citation
Liang J, Nagahashi M, Kim EY, Harikumar KB, Yamada A, Huang WC, Hait NC, Allegood JC, Price MM, Avni D, Takabe K, Kordula T, Milstien S, Spiegel S. Sphingosine-1-phosphate links persistent STAT3 activation, chronic intestinal inflammation, and development of colitis-associated cancer. Cancer Cell. 2013 Jan 14;23(1):107-20. doi: 10.1016/j.ccr.2012.11.013. Epub 2012 Dec 27.
Results Reference
background
PubMed Identifier
26216954
Citation
Ijssennagger N, Belzer C, Hooiveld GJ, Dekker J, van Mil SW, Muller M, Kleerebezem M, van der Meer R. Gut microbiota facilitates dietary heme-induced epithelial hyperproliferation by opening the mucus barrier in colon. Proc Natl Acad Sci U S A. 2015 Aug 11;112(32):10038-43. doi: 10.1073/pnas.1507645112. Epub 2015 Jul 27.
Results Reference
background
PubMed Identifier
23239972
Citation
IJssennagger N, Derrien M, van Doorn GM, Rijnierse A, van den Bogert B, Muller M, Dekker J, Kleerebezem M, van der Meer R. Dietary heme alters microbiota and mucosa of mouse colon without functional changes in host-microbe cross-talk. PLoS One. 2012;7(12):e49868. doi: 10.1371/journal.pone.0049868. Epub 2012 Dec 11.
Results Reference
background
PubMed Identifier
20962160
Citation
Zimmermann MB, Chassard C, Rohner F, N'goran EK, Nindjin C, Dostal A, Utzinger J, Ghattas H, Lacroix C, Hurrell RF. The effects of iron fortification on the gut microbiota in African children: a randomized controlled trial in Cote d'Ivoire. Am J Clin Nutr. 2010 Dec;92(6):1406-15. doi: 10.3945/ajcn.110.004564. Epub 2010 Oct 20.
Results Reference
background
PubMed Identifier
21076126
Citation
Werner T, Wagner SJ, Martinez I, Walter J, Chang JS, Clavel T, Kisling S, Schuemann K, Haller D. Depletion of luminal iron alters the gut microbiota and prevents Crohn's disease-like ileitis. Gut. 2011 Mar;60(3):325-33. doi: 10.1136/gut.2010.216929. Epub 2010 Nov 12.
Results Reference
background
PubMed Identifier
23467095
Citation
Kleinewietfeld M, Manzel A, Titze J, Kvakan H, Yosef N, Linker RA, Muller DN, Hafler DA. Sodium chloride drives autoimmune disease by the induction of pathogenic TH17 cells. Nature. 2013 Apr 25;496(7446):518-22. doi: 10.1038/nature11868. Epub 2013 Mar 6.
Results Reference
background
PubMed Identifier
23467085
Citation
Wu C, Yosef N, Thalhamer T, Zhu C, Xiao S, Kishi Y, Regev A, Kuchroo VK. Induction of pathogenic TH17 cells by inducible salt-sensing kinase SGK1. Nature. 2013 Apr 25;496(7446):513-7. doi: 10.1038/nature11984. Epub 2013 Mar 6.
Results Reference
background
PubMed Identifier
23467089
Citation
Yosef N, Shalek AK, Gaublomme JT, Jin H, Lee Y, Awasthi A, Wu C, Karwacz K, Xiao S, Jorgolli M, Gennert D, Satija R, Shakya A, Lu DY, Trombetta JJ, Pillai MR, Ratcliffe PJ, Coleman ML, Bix M, Tantin D, Park H, Kuchroo VK, Regev A. Dynamic regulatory network controlling TH17 cell differentiation. Nature. 2013 Apr 25;496(7446):461-8. doi: 10.1038/nature11981. Epub 2013 Mar 6.
Results Reference
background
PubMed Identifier
14361377
Citation
HAAS SV, HAAS MP. The treatment of celiac disease with the specific carbohydrate diet; report on 191 additional cases. Am J Gastroenterol. 1955 Apr;23(4):344-60. No abstract available.
Results Reference
background
PubMed Identifier
25016597
Citation
Halmos EP, Christophersen CT, Bird AR, Shepherd SJ, Gibson PR, Muir JG. Diets that differ in their FODMAP content alter the colonic luminal microenvironment. Gut. 2015 Jan;64(1):93-100. doi: 10.1136/gutjnl-2014-307264. Epub 2014 Jul 12.
Results Reference
background
PubMed Identifier
16162680
Citation
Lindsay JO, Whelan K, Stagg AJ, Gobin P, Al-Hassi HO, Rayment N, Kamm MA, Knight SC, Forbes A. Clinical, microbiological, and immunological effects of fructo-oligosaccharide in patients with Crohn's disease. Gut. 2006 Mar;55(3):348-55. doi: 10.1136/gut.2005.074971. Epub 2005 Sep 14.
Results Reference
background
PubMed Identifier
27077959
Citation
Halmos EP, Christophersen CT, Bird AR, Shepherd SJ, Muir JG, Gibson PR. Consistent Prebiotic Effect on Gut Microbiota With Altered FODMAP Intake in Patients with Crohn's Disease: A Randomised, Controlled Cross-Over Trial of Well-Defined Diets. Clin Transl Gastroenterol. 2016 Apr 14;7(4):e164. doi: 10.1038/ctg.2016.22.
Results Reference
background
PubMed Identifier
20679230
Citation
De Filippo C, Cavalieri D, Di Paola M, Ramazzotti M, Poullet JB, Massart S, Collini S, Pieraccini G, Lionetti P. Impact of diet in shaping gut microbiota revealed by a comparative study in children from Europe and rural Africa. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14691-6. doi: 10.1073/pnas.1005963107. Epub 2010 Aug 2.
Results Reference
background
PubMed Identifier
26655069
Citation
Obih C, Wahbeh G, Lee D, Braly K, Giefer M, Shaffer ML, Nielson H, Suskind DL. Specific carbohydrate diet for pediatric inflammatory bowel disease in clinical practice within an academic IBD center. Nutrition. 2016 Apr;32(4):418-25. doi: 10.1016/j.nut.2015.08.025. Epub 2015 Nov 30.
Results Reference
background
PubMed Identifier
28030510
Citation
Suskind DL, Cohen SA, Brittnacher MJ, Wahbeh G, Lee D, Shaffer ML, Braly K, Hayden HS, Klein J, Gold B, Giefer M, Stallworth A, Miller SI. Clinical and Fecal Microbial Changes With Diet Therapy in Active Inflammatory Bowel Disease. J Clin Gastroenterol. 2018 Feb;52(2):155-163. doi: 10.1097/MCG.0000000000000772.
Results Reference
background

Learn more about this trial

SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis

We'll reach out to this number within 24 hrs