Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 55 Years|
- - Documented diagnosis of Crohn's disease - Harvey Bradshaw Index (HBI) score <4 (indicating quiescent disease, remission) - Short Crohn's Disease Activity Index score (sCDAI) <150 (indicating quiescent disease, remission) - Signed written informed consent.
- - Able to receive food shipments delivered to a work or home environment.
- - Negative pregnancy test at screening visit in females of childbearing potential - Use of appropriate contraceptive methods for females of childbearing potential and males with procreative capacity during treatment - Stable medication use for ≥2 months at time of study enrolment, including but not limited to: steroids/corticosteroids, biologic therapy (infliximab, adalimumab, certolizumab pagol, golimumab, natalizumab, vedolizumab).
- - Able to take oral nutrition and medication intake for 6 months prior to and at time of study enrolment.
- - Medical Exclusion: - Short bowel syndrome.
- - Hospitalized patients - Body mass Index <19 kg/m or ≥35.
- - Current smoker.
- - Harvey Bradshaw Index (HBI) >4 or a short Crohn's disease Activity Index (sCDAI) >150 - Known clinically significant cardiovascular disease/conditions - Known clinically significant liver/gallbladder/pancreatic disease/dysfunction - Known allergy to soy, wheat, peanuts - Celiac disease - Serious secondary illnesses of an acute or chronic nature, which in the opinion of the Investigator renders the patient unsuitable for inclusion into the study.
- - Dementia.
- - Uncontrolled Diabetes Type I type II (fasting plasma glucose 7.0mM diabetics or pre-diabetics) - Known drug abuse.
- - Known parasitic disease of the digestive system.
- - HIV-infection.
- - Seizure disorder.
- - Presence of an ileal or colonic stoma.
- - Known previous or concurrent malignancy.
- - Anticipated need for surgery within 6 weeks - Albumin<2.0mg/dl, within 4 weeks of screening (if tested as part of routine clinical care) - Current use of hormonal or estrogen replacement therapies.
- - Documented C difficile colitis within four weeks of screening Dietary Exclusion: • Use of exclusively Soy-based diet within 4 weeks of screening Medication Exclusion: - Other conditions that would be a contraindication to and of the study diets (e.g. allergy to soy, wheat, peanuts) or preclude the participant fron completing the study - Use of antibiotics within last 60 days.
- - Use of pre- or probiotics within last 60 days.
- - Start or change dose of IBD related medications within 8 weeks prior to enrollment: thiopurines (azathioprine and 6-MP), methotrexate, natalizumab, or vedolizumab, anti-TNF agents (including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), golimumab (Simponi) or ustekinumab Other - Well-founded doubt about the patient's cooperation.
- - Existing pregnancy, lactation, or intended pregnancy or impregnation within the next 3 months.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Case Western Reserve University|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Fabio Cominelli, MD, PhD|
|Principal Investigator Affiliation||Case Western Reserve University, School of Medicine, Gastroenterology|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
The Central Hypothesis The central hypothesis of this study is that amino acids sourced from soy protein, a lysine rich, non-animal dietary substrate can serve as a major nutrient source for bacterial phyla capable of butyrate synthesis in the gut, and that soy protein has a protective effect for epithelial integrity in periods of low-grade inflammation in Crohn's disease. To answer our central hypothesis, the human diet intervention study represents the one of two specific aims of a study that integrates both a human and experimental research design. Samples collected in the dietary study involving patients with CD (Specific Aim 1, see below) will be used to complete the objectives described under Specific Aim 2 (see below) in experimental mice. Case Western Reserve University's (CWRU) Institutional Animal Care and Use Committee (IACUC) has reviewed and approved the Animal Experimentation 2014-0158 described under Specific Aim 2. Study Objectives This single center open label study is designed to address the following objectives. Specific Aim 1: To compare the effectiveness of a soy-based diet dietary intervention given for 7 days to change the gut microbiota composition to that of baseline (pre-diet) in patients with Crohn's disease (CD) and in remission. Primary Objectives of Specific Aim 1 1. To monitor patients for clinical symptoms related to maintenance of clinical remission during study period. Clinical symptoms will be assessed using the short Crohn's Disease Activity Index (sCDAI), a reliable and valid tool for assessment of Crohn's disease activity. • Hypothesis: Patients will not experience any clinical symptoms indicative of loss of clinical remission or adverse events as both diet interventions include normal, healthy food. 2. To assess the feasibility of the study diets. Secondary Objectives of Specific Aim 1 1. To quantify change gut bacteria taxonomic profiles in stool samples collected from CD patients after a soy-based dietary intervention, for 7 days each;. • Hypothesis: Patients will have differences in their fecal bacterial composition after consuming a soy-based diet, compared their 'baseline' diet. 2. To quantify gut bacterial butyrate in stool samples collected from CD patients after a soy-based dietary intervention, for 7 days. • Hypothesis: Dietary substrates sourced from a soy-based diet promote butyrate synthesis through different bacterial community members. 3. To assess the proportion of patients who intend to continue the study diets when prepared food is no longer provided without cost, and the reasons for discontinuation of either diet (compared to resuming usual food habits). Dose Rationale of Specific Aim 1 Participants will be asked to exclusively eat for 7 days, a soy-based diet immediately followed by participants resume their usual dietary habits. The primary outcome (self-reported sCDAI) will be assessed during the 7 day period of the diet. The 7-day diet time period was chosen for two reasons. First, dietary interventions in humans, specifically those plant and animal protein based, have been shown to alter gut microbial communities, including microbial gene expression in a rapid, diet-specific manner in as little as days(Wu, et al.Science, 2011; David, et al. Nature, 2014). Therefore 7 days is sufficient to meet the purpose of specific aim 1. Second, we felt that patients would be more likely to adhere to a diet exclusively focused on one specific food type over a shorter, period (7 days) if they did not perceive a direct benefit and to this end, would be more willing to collect stool samples. Specific Aim 2: Determine the functional significance of Soy-based diet altered microbiota in germ-free SAMP1/YitFC (SAMP) mice. The purpose of Aim 2 is to perform fecal microbiota transplantation (FMT) experiments in germ-free (GF) SAMP mice to test directly that the soy-based diet altered microbiota (Specific Aim 1) has increased butyrate producing capacity and to determine whether this could protect epithelial integrity against mild inflammation. Fecal microbiota obtained from CD patients treated with soy diet (Aim 1) will be transplanted into germ-free SAMP mice to test dietary substrates (amino acids sourced from non-animal food) potential for maintaining epithelial integrity via butyrate as a surrogate treatment for maintaining clinical remission in CD patients with, or at risk for residual active disease. We expect to identify potential short-term diet based therapeutic modalities, in context to baseline microbiota, designed for enhancing the anti-inflammatory effects of commensal microbiota on epithelial integrity. Primary Objectives for Specific Aim 2 1. To determine whether the diet-altered fecal microbiota from CD patients (Specific Aim 1) has increased butyrate producing capacity following in recipient GF SAMP mice after FMT. • Hypothesis: Microbial alterations induced by a soy protein based diet has increased butyrate producing capacity and a soy protein can be a surrogate for butyrate production in the gut. 2. To determine the gut microbial metabolite profiles in recipient GF SAMP mice after FMT. • Hypothesis: Transplanted mice will exhibit a mirrored pattern of metabolite profiles found in respective human CD patient donors. 3. To determine whether FMT (as above) in recipient germ-free SAMP mice administered a low concentration of DSS could protect epithelial integrity against mild inflammation.
- - Hypothesis: Microbial alterations induced by a soy protein based diet has a protective effect for epithelial integrity in periods of low-grade inflammation.
Other: Crohn's disease patients in remission
Crohn's disease patients will follow an identical diet intervention protocol therefore no randomization will be performed after enrollment. Participants will follow a soy-based diet for 7 days. The diet will be preceded by a 12-hr overnight fast and will be immediately followed by a wash out period for a minimum of 7 days and no longer than 14 days.
Other: - Soy based diet
The diet will be based on the detailed descriptions according to the American Heart Association, US Food and Drug Administration (FDA), and the Soyfoods Association of North America Website, which all promote soy products as having beneficial nutrient profiles with a daily consumption of 25 grams or more of soy protein (average serving = 6.25 grams), upper limit of 50g.
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