IBD-AID
DAIN: A Culturally Tailored Dietary Intervention to Treat Crohn's Disease
The goal of the study is to test the efficacy of a dietary intervention in inducing clinical response and remission for patients with Crohn's disease in a randomized controlled trial. The intervention diet: DAIN has been adapted from the Inflammatory Bowel Disease Anti-Inflammatory Diet or IBD-AID™ taking into account the food availability and preferences of Puerto Ricans. DAIN also includes traditional foods commonly consumed in the typical Puerto Rican diet while maintaining the fundamental components of the IBD-AID™.
Sponsor: University of Massachusetts, Worcester
Trial Type: Interventional
First Posted: Nov. 25, 2022
Modeling Patient Response to a Therapeutic Diet in Crohn's Disease (TDI)
is proposed randomized controlled trial (RCT) explores the efficacy of a Crohn's Disease (CD) Therapeutic Dietary Intervention (TDI) compared to conventional management (CM) to induce steroid-free clinical remission at week 13 in patients with active, mild-to-moderate luminal CD. For asymptomatic patients with active disease, efficacy of the diet will be explored by using fecal calprotectin and sonographic findings.
Sponsor: University of Calgary
Trial Type: Interventional
First Posted: Oct. 22, 2020
Study of Dietary Composition in Crohn's Disease (CD)
A randomized controlled trial of the anti-inflammatory whole food diet versus usual diet for the induction of remission in 104 adults with mild-to-moderate Crohn's Disease (CD). The anti-inflammatory whole food diet will be compared to participants usual diet for understanding its effects on achieving clinical remission, clinical response, reduction in serological and fecal markers of inflammation, and improvement in patient-reported outcomes, such as physical activity, anxiety, depression, fatigue, pain, sleep disturbance, social satisfaction, and quality of life. The study will involve collection of blood and fecal specimens to evaluate the effects of the anti-inflammatory diet on the gut microbiome, bacterial metabolome, innate immune markers, and fecal microRNA profiles. The participants will be placed on anti-inflammatory diet for 8 weeks and assessed every 2 weeks for adherence.
Sponsor: University of California, Los Angeles
Trial Type: Interventional
First Posted: June 16, 2020
SCD,
MED
SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
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.
Sponsor: Massachusetts General Hospital
Trial Type: Interventional
First Posted: May 21, 2020
CDED
Prospective Dietary Therapy Using Crohn's Disease Exclusion Diet for Ileal Pouch Anal Anastomosis Patients
Although, pouchitis patients are former UC patients, the disease occurs in the small intestine, similarly to Crohn's disease (CD). Further, the disease can be clinically similar to CD, involving the proximal gastro-intestinal tract and causing strictures, fistula, or perianal disease. The Crohn's Disease Exclusion Diet (CDED) reduces exposure to all the components identified in rodent models as well as two components that are highly suspect but have not been investigated in models. The diet also provides dietary components that may favor species (especially SCFA producers) which appear to be deficient in CD. The investigator therefore aims to examine the microbial, mucosal and immunological changes of the pouch during one year post IPAA, and examine the impact of the CDED on disease activity and dysbiosis in a cohort of adults suffering from active pouchitis.
Sponsor: Tel-Aviv Sourasky Medical Center
Trial Type: Interventional
First Posted: March 31, 2020
Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease
The study is 3 arms observational study with no intervention that aims to understand the link between Crohn's disease, microbiome and diet in children. 150 children newly diagnosed with Crohn's disease will participate in the study and their data will be used to create an algorithm about their microbiome, disease, diet, etc. 100 other children newly diagnosed will participate in the study and their data will be use to validate the algorithm. The investigators will be recruiting 50 healthy participants: 20 that are undergoing an endoscopy for abdominal pain and 30 that comes to the physician for different reasons.
Sponsor: Weizmann Institute of Science
Trial Type: Observational
First Posted: Feb. 25, 2020
The Impact of Time Restricted Feeding in Crohn's Disease (TRF-CD)
Time-restricted feeding (TRF) is a dietary regimen involving the consumption of food and liquids within a defined time window with or without additional restriction on dietary composition. TRF has been associated with improvements in inflammation, host metabolism, autophagy, gut microbial composition, and gut permeability. Crohn's disease is an inflammatory bowel disease of unknown etiology that likely results from a combination of genetic and environmental factors. This proposed study will test the hypothesis that a time-restricted feeding regimen will improve clinical outcomes and favorably influence the gut microbiome in patients with active Crohn's disease. If time-restricted fasting proves beneficial to this patient population then it will pave the way for larger, prospective studies and clinical trials.
Sponsor: Weill Medical College of Cornell University Collaborator:
Trial Type: Interventional
First Posted: Feb. 17, 2020
Adjunctive Treatment With Vitamin D3 in Patients With Active IBD (ACTIVATED)
Besides its traditional role in bone homeostasis, several studies have recognized the important role Vitamin D plays in modulating the immune response, cancer, and cardiovascular disease. Specifically, Vitamin D may mediate immunity by modulating autophagy in leukocytes and regulating the gut microbiome. Thus, Vitamin D may play an important role in IBD. Furthermore, evidence suggests that the effect of vitamin D may be mediated through the TNF-α pathway, suggesting a synergy with anti-TNF therapy. This is a randomized, double blind, placebo-controlled trial to study the effect of Vitamin D3 as an adjunct therapy for patients with active CD, UC, or IBD unspecified who are undergoing anti-TNF induction therapy.
Sponsor: Massachusetts General Hospital
Trial Type: Interventional
First Posted: Jan. 13, 2020
CD-TREAT
The Intensive Post Exclusive Enteral Nutrition Study (iPENS)
The aim of this study is to investigate this phenomenon by exploring if diet and gut bacteria play a role. Furthermore, the investigators aim to test whether a new, ordinary food-based diet, called the Crohn's Disease TReatment with EATing (CD-TREAT) diet can help control gut inflammation during the early food reintroduction phase, after EEN completion, compared to an unrestricted, free diet.
Sponsor: NHS Greater Glasgow and Clyde
Trial Type: Interventional
First Posted: Jan. 13, 2020
"Tasty and Healthy" Dietary Approach for Crohn's Disease
The aim of this proposal is to explore the effectiveness of the "Tasty&Healthy" dietary approach based on avoiding "pro-inflammatory" and processed ingredients, for inducing and maintaining remission and MH in children and young adults.
Sponsor: Shaare Zedek Medical Center
Trial Type: Interventional
First Posted: Jan. 7, 2020
SCD
Low Animal Protein(LAP) modified Specific Carbohydrate Diet in Pediatric Ulcerative Colitis
For this study, the investigators will examine the effect of low animal protein diet modified SCD in active ulcerative colitis. The investigators are examining how well a LAP SCD is tolerated and whether the LAP SCD appears effective for the treatment of active UC. Patients will be evaluated at 2, 4, 8, and 12 weeks with CBC, sedimentation rate, C-reactive protein, albumin, and stool for microbiome analysis at each follow up visit.
Sponsor: David Suskind, Seattle Children's Hospital
Trial Type: Interventional
First Posted: Jan. 3, 2020
Diet Intervention for Crohn's Disease Patient
The purpose of this study is to determine the effectiveness of a low-fat, high fiber diet (LFD) containing a minimal proportion of fat to improve gastrointestinal symptoms, quality of life and signs of inflammation in blood and stool.
Sponsor: University of Miami
Trial Type: Interventional
First Posted: Dec. 30, 2019