Ulcerative ColitisNCT04398550
SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
A study testing Specific Carbohydrate Diet and Mediterranean Diet in people with Ulcerative Colitis, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Specific Carbohydrate Diet and Mediterranean Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Katherine Williams, 617-643-9374, kwilliams81@mgh.harvard.edu
Jessica McGoldrick, jmcgoldrick2@mgh.harvard.edu
About this study
Official title: Specific Carbohydrate Diet vs. Mediterranean Diet Therapy in Ulcerative Colitis - A Clinical Trial
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.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Specific Carbohydrate Diet, Mediterranean Diet
- Keywords
- Diet
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific Carbohydrate DietOther
Diet restricts all but simple carbohydrates and allows for inclusion of fresh fruits, vegetables, unprocessed meats, and homemade lactose-free cheese and yogurt.
Mediterranean DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Specific Carbohydrate Diet | Experimental | Exclusive consumption of the specific carbohydrate diet for 6 weeks Receives: Other: Specific Carbohydrate Diet |
| Mediterranean Diet | Experimental | Exclusive consumption of the Mediterranean diet for 6 weeks Receives: Other: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 6
Secondary outcomes (7)
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).
Measured: Week 1, Week 2, Week 4, Week 10 follow-up
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).
Measured: Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
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.
Measured: Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
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).
Measured: Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
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.
Measured: Week 6 and Week 10 follow-up
fecal calprotectin
Stool samples will be taken at screening/baseline and week 6 and 10 to assess change in fecal calprotectin levels.
Measured: Week 6 and Week 10 follow-up
C-reactive protein
Blood will be drawn at baseline and week 6 to assess change in C-reactive protein levels.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start3 Sep 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamed Khalili, Massachusetts General Hospital
- Investigators
- Hamed Khalili, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398550
- Sponsor's protocol ID
- 2020P000298
- Status last verified
- May 2022
- First submitted
- 24 Feb 2020
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only de-identified information may be shared with other collaborators and entities involved in generating data.
Publications
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.
PubMed 24503132Ferguson 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.
PubMed 8200562Poullis 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.
PubMed 14973103Martinez-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.
PubMed 23598352Stenman 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.
PubMed 23203158Lee 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.
PubMed 25597840Jowett 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.
PubMed 15361498Magee 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.
PubMed 15705205Degagne 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.
PubMed 25347472Jantchou 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.
PubMed 20461067Liang 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.
PubMed 23273921Ijssennagger 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.
PubMed 26216954IJssennagger 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.
PubMed 23239972Zimmermann 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.
PubMed 20962160Werner 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.
PubMed 21076126
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Carbohydrate Diet vs. Mediterranean Diet Therapy in Ulcerative Colitis - A Clinical Trial
- ClinicalTrials.gov ID
- NCT04398550
- Acronym / sponsor ID
- 2020P000298
- Conditions
- Ulcerative Colitis
- Keywords
- Diet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific Carbohydrate Diet | Experimental | Other: Specific Carbohydrate DietExclusive consumption of the specific carbohydrate diet for 6 weeks |
| Mediterranean Diet | Experimental | Other: Mediterranean DietExclusive consumption of the Mediterranean diet for 6 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific Carbohydrate DietDiet restricts all but simple carbohydrates and allows for inclusion of fresh fruits, vegetables, unprocessed meats, and homemade lactose-free cheese and yogurt. | Other | Specific Carbohydrate Diet |
| Mediterranean DietDiet 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. | Other | Mediterranean Diet |
Primary outcome
Partial Mayo Clinic Score
Time frame: Week 6
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).
7 secondary outcomes
Partial Mayo Clinic Score
Time frame: Week 1, Week 2, Week 4, Week 10 follow-up
Inflammatory Bowel Disease Questionnaire (IBDQ10)
Time frame: Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
Short Form (12) Health Survey (SF-12)
Time frame: Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
Simple Clinical Colitis Activity Index (SCCAI)
Time frame: Week 1, Week 2, Week 4, Week 6, and Week 10 follow-up
stool microbiome
Time frame: Week 6 and Week 10 follow-up
fecal calprotectin
Time frame: Week 6 and Week 10 follow-up
C-reactive protein
Time frame: Week 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Background: PubMed 24503132Albenberg 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.
- Background: PubMed 8200562Ferguson 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.
- Background: PubMed 14973103Poullis 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.
- Background: PubMed 23598352Martinez-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.
- Background: PubMed 23203158Stenman 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.
- Background: PubMed 25597840Lee 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.
- Background: PubMed 15361498Jowett 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.
- Background: PubMed 15705205Magee 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.
- Background: PubMed 25347472Degagne 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.
- Background: PubMed 20461067Jantchou 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.
- Background: PubMed 23273921Liang 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.
- Background: PubMed 26216954Ijssennagger 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.
- Individual participant dataSharing planned: No. Only de-identified information may be shared with other collaborators and entities involved in generating data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hamed Khalili, MD, MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific Carbohydrate Diet and Mediterranean Diet in people with Ulcerative Colitis, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamed Khalili, MD, MPH (978-882-6709, hkhalili@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial Mayo Clinic Score (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398550, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.